U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Maternal and Child Health Bureau

Emergency Medical Services for Children Program

EMSC Network Development Demonstration Project

Announcement Type: New Competing and ContinuationAnnouncement Number: HRSA-11-079

Catalog of Federal Domestic Assistance (CFDA) No. 93.127

FUNDING OPPORTUNITY ANNOUNCEMENT

Fiscal Year 2011

Letter of Intent Due Date: February 15, 2011

Ensure your Grants.gov registration and passwords are current immediately!!Deadline extensions are not granted for lack of registration.

Registration can take up to one month to complete.

Application Due Date: March 16, 2011

Release Date: January 13, 2011Date of Issuance: January 19, 2011

Modified on 1/20/11 to clarify that cost sharing is NOT required for this opportunity (Page 13)

Tasmeen Weik, DrPHPublic Health AnalystEmergency Medical Services for Children ProgramEmail: tweik@hrsa.govTelephone: (301) 443-8927Fax: (301) 443-1296

PART I: COVER PAGE/OVERVIEW

Legislative Authority: Public Health Service Act, Title XIX, Section 1910, (42 U.S.C. 300w-9); as amended by Section 5603 of The Patient Protection and Affordable Care Act, P.L. 111-148.

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EXECUTIVE SUMMARY

We are pleased to provide you with the Emergency Medical Services for Children (EMSC) funding opportunity announcement (FOA) for the Network Development Demonstration Project (NDDP). Support is available from the Division of Child, Adolescent and Family Health (DCAFH), part of the Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA) in the U.S. Department of Health and Human Services (DHHS). Please read the entire FOA carefully before completing the application.

The purpose of the EMSC-NDDP cooperative agreement is to continue to demonstrate the value of an infrastructure or network designed to be the platform from which to conduct investigations on the efficacy of treatments, transport, and care responses in emergency care settings including those preceding the arrival of children to hospital emergency departments. Funded NDDP cooperative agreements and a separately funded data center make up the Pediatric Emergency Care Applied Research Network (PECARN). This infrastructure helps to overcome present challenges in conducting high quality, rigorous, investigations in pediatric emergency medicine. Further information about the currently funded PECARN projects can be found at http://www.pecarn.org

Qualified Applicants: State governments and accredited schools of medicine are the only eligible applicants for funding under the EMSC Program.

Number of Grants: up to six (6) will be awarded.

Funds per year: an award of up to $630,000 in total (direct and indirect) costs per year for four (4) years for each of the six (6) awards.

Application Availability: January 14, 2011

Deadline: March 16, 2011

Award: September 1, 2011

Project Period: September 1, 2011 – August 30, 2015

Applicants may obtain additional information regarding business, administrative, or fiscal issues related to this grant announcement by contacting:

Mail: Ms. Thais Diaz-MacalusoGrants Management SpecialistHRSA Division of Grants Management OperationsParklawn Building, Room 11A-025600 Fishers LaneRockville, Maryland 20857

Telephone: (301) 443-0682Email: TDiaz-macaluso@hrsa.gov

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Additional information related to overall program issues and technical assistance may be obtained by contacting:

Mail: Tasmeen Weik, DrPHEMSC Program DirectorMaternal and Child Health Bureau5600 Fishers LaneRoom 18A-38Rockville, Maryland 20857

Telephone: (301) 443-8927Email: tweik@hrsa.gov

Technical Assistance CallA technical assistance call to answer questions related to this guidance will be held on January 24 at 12:00pm ET. To access the call and online web demonstration, please follow directions below. To Join the Phone Conference: Phone Number (Long Distance):   877-355-6338 Enter 1 to attend meeting.Enter Meeting ID: 1234Tip – Always mute your line when you are not speaking to reduce distractions.  Press #5 to mute and #5 to un-mute.

TO ATTEND THE WEB CONFERENCE: * please follow instructions above to join the audio portion* 1. Go to: https://meetingplace.cnmc.org/a/19c00cc9e21424d0f2ddd97778ea68a4 2. Sign in as a Guest  and click on Attend Meeting.    - Accept any security warnings you receive and wait for the Meeting Room to initialize. 3. Click on CONNECT 

NOTE: do not check the option to have the system call you. Uncheck the box before connecting*

 TEST YOUR BROWSER BEFORE YOU ATTEND YOUR FIRST WEB CONFERENCE Visit https://meetingplace.cnmc.org/test/ to test your web browser for compatibility with the web conference.

Please submit your application early. Applications submitted after the application deadline will not be accepted. The application deadline is March 16, 2011 at 8:00 P.M. ET.

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Table of Contents

I. FUNDING OPPORTUNITY DESCRIPTION...........................................................................1

1. PURPOSE................................................................................................................................12. BACKGROUND.......................................................................................................................2

II. AWARD INFORMATION...................................................................................................11

1. TYPE OF AWARD.................................................................................................................112. SUMMARY OF FUNDING......................................................................................................13

III. ELIGIBILITY INFORMATION.......................................................................................13

1. ELIGIBLE APPLICANTS.......................................................................................................132. COST SHARING/MATCHING................................................................................................133. OTHER.................................................................................................................................13

IV. APPLICATION AND SUBMISSION INFORMATION.................................................14

1. ADDRESS TO REQUEST APPLICATION PACKAGE..............................................................142. CONTENT AND FORM OF APPLICATION SUBMISSION.......................................................14

iii. Application Checklist.....................................................................................................18iv. Budget.............................................................................................................................18v. Budget Justification.......................................................................................................18vi. Staffing Plan and Personnel Requirements.................................................................22vii. Assurances.....................................................................................................................22viii. Certifications..................................................................................................................22ix. Project Abstract..............................................................................................................22x. Program Narrative.........................................................................................................23xi. Program Specific Forms................................................................................................29xii. Attachments....................................................................................................................29

3. SUBMISSION DATES AND TIMES.........................................................................................304. INTERGOVERNMENTAL REVIEW........................................................................................315. FUNDING RESTRICTIONS....................................................................................................316. OTHER SUBMISSION REQUIREMENTS................................................................................31

V. APPLICATION REVIEW INFORMATION.....................................................................32

1. REVIEW CRITERIA..............................................................................................................322. REVIEW AND SELECTION PROCESS...................................................................................323. ANTICIPATED ANNOUNCEMENT AND AWARD DATES.......................................................34

VI. AWARD ADMINISTRATION INFORMATION............................................................34

1. AWARD NOTICES................................................................................................................342. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS...........................................343. REPORTING.........................................................................................................................36

VII. AGENCY CONTACTS......................................................................................................38

VIII. OTHER INFORMATION................................................................................................39

IX. TIPS FOR WRITING A STRONG APPLICATION.......................................................39

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APPENDIX A: MCHB ADMINISTRATIVE FORMS AND PERFORMANCE MEASURES.................................................................................................................................40

IX. TIPS FOR WRITING A STRONG APPLICATION.......................................................39

APPENDIX A: MCHB ADMINISTRATIVE FORMS AND PERFORMANCE MEASURES.................................................................................................................................40

APPENDIX B: PECARN POLICIES AND PROCEDURES………………………………90

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I. Funding Opportunity Description

1. Purpose

The Emergency Medical Services for Children (EMSC) award program is administered by the Department of Health and Human Services (DHHS), Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB). The program is authorized by the Public Health Service Act, Title XIX, Section 1910 (42 U.S.C. 300w-9); as amended by Section 5603 of The Patient Protection and Affordable Care Act, P.L. 111-148. This Federal initiative evolved out of a growing recognition that children have unique needs in emergency situations––needs that often vary from those of adults due to physiological, developmental and psychological differences. The goal of the EMSC program is to reduce child and youth mortality and morbidity sustained as a result of severe illness or trauma. The EMSC program does not intend to promote the development of a separate EMS system for children, but rather to enhance the pediatric capability of EMS systems originally designed primarily for adults. EMS is understood broadly to include the following components: prevention, pre-hospital, hospital-based emergency care, rehabilitation and reentry of the child into the community.

Legislation passed by Congress in 1984 authorized the use of Federal funds to expand and improve emergency medical services for children in each State. Since 1984, 56 States, Territories and the District of Columbia, have received grants. In addition, two national resource centers, the EMSC National Resource Center (EMSC-NRC) and the National EMSC Data Analysis Resource Center (NEDARC) are being supported and several other projects under Targeted Issues grants which support projects of national significance. The current competition is to support the infrastructure for the Pediatric Emergency Care Applied Research Network (PECARN).

The purpose of the funding opportunity announcement (FOA) is to invite cooperative agreement applications from experienced clinical investigators to participate in the Emergency Medical Services for Children Network Development Demonstration Project (EMSC-NDDP). The purpose of the EMSC-NDDP is to demonstrate the value of an infrastructure or network designed to be the platform from which to conduct investigations on the efficacy of treatments, transport, and care responses in pediatric emergency care. This infrastructure helps to overcome present difficulties in assessing efficacy and quality of care that derive from the relatively small incidence rates of pediatric emergency events. The infrastructure is a means to conduct observational and interventional studies on a variety of issues related to EMSC, including processes involved in transferring research results to treatment settings.

Funded NDDP cooperative agreements and a separately funded data center make up the Pediatric Emergency Care Applied Research Network (PECARN). More information on PECARN can be found at http://www.pecarn.org. Specific information about the requirements of the applicant is included in Section IV (x) “Program Narrative.”

MCHB’s intent is to ensure that project interventions are responsive to the cultural and linguistic needs of special populations, that services are family-centered and accessible to consumers, and that the broadest possible representation of culturally distinct and historically under represented groups is supported through programs and projects sponsored by the MCHB.

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2. Background

Pediatric emergencies are of two types, (1) injury related and (2) non-injury related. Injury is the leading cause of death among children between the ages of 1 and 19, claiming more than 20,000 lives each year. Nonfatal injuries occur far more frequently. It is estimated that 20 million children ages 18 and under experienced injuries; 93% of these children required some type of medical attention. Approximately 75% of childhood injuries stem from unintentional causes such as motor vehicle crashes, burns, drowning, drug overdose, and poisoning. The remainder can be attributed to suicide, homicide, and child abuse and neglect.

Non-injury emergencies (illnesses), medical and otherwise, constitute the remaining component of the pediatric emergencies equation. Annual incidence figures are in the millions. This includes emergencies prompted by the exacerbation of underlying chronic conditions such as asthma, chronic cognitive and physical impairments, as well as those related to infectious diseases and to non-specific symptoms interpreted by physicians and/or parents to require prompt diagnostic evaluation and resolution through hospital-based medical care.

Adding complexities to the care and overall management of pediatric emergencies is the uniqueness of childhood. It is more difficult to assess the severity of illness or injury in children than in adults. Important anatomic, physiologic, and developmental differences exist between children and adults: children are smaller and proportioned differently; normal respiratory rates, heart rates, and blood pressure differ; characteristic changes in vital signs that signal deterioration in adults may not occur in children and stages in children’s physiologic, emotional, and behavioral development affect their responses to medical care and their risk of injury and illness.

Despite the many advances in creating and improving EMS systems and incorporating pediatric components into them, relatively little empirical data has been collected about how EMS and EMSC systems operate, about the efficacy of the clinical procedures being employed at the hospital level to treat and manage children who have experienced an emergency event, nor about the efficacy of the transport systems and clinical procedures used to treat and manage children prior to their arrival at the hospital. Information on the cost effectiveness of the various EMS and EMSC system configurations and of the various ways being used to handle clinical pediatric emergencies is also lacking.

The dearth of science-based knowledge about pediatric emergencies and how to best manage them has not gone unnoticed. The issue has been raised by many professionals in the field who have found that it constitutes a major barrier to the prevention and reduction of the annual toll in mortality and morbidity. Calls by experts to mount a nationwide research initiative in emergency medical services were made in 1991 and 1993. In addition, in 2006, the Institute of Medicine published three reports on the emergency care system in the U.S. The three reports focused on emergency medical services, hospital based care and pediatric care. Of particular importance to this competition is the pediatric report and the gaps in research identified by that report. See reference below:

Emergency Care for Children: Growing Pains. 2006 Institute of MedicineAvailable at: http://www.iom.edu/CMS/3809/16107/35002.aspx

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The following information provides the background information necessary to understand the conceptual framework of PECARN and the integration of individual awardees into the PECARN. Specific information about the requirements of the applicant is included in Section IV (x) “Program Narrative”.

PECARN

The Pediatric Emergency Care Applied Research Network (PECARN) was established in response to the above concerns in 2001. Four cooperative agreements were awarded in 2001 along with an award for a Central Data Management Coordinating Center (CDMCC) to support PECARN data functions in 2002. Four interrelated reasons support the continuation of PECARN: 1) Incidence rates of pediatric emergency events are relatively small, requiring pooling of sites and treatment experiences to conduct research; 2) large numbers of children are required to attain diverse and representative study samples; 3) an infrastructure is needed to test the efficacy of treatments and of the transport and care responses that precede the arrival of children to hospital emergency departments; and 4) a mechanism is required by which to study the processes involved in transferring research results to treatment settings. The network is expected to forge partnerships among Federal agencies, EMSC researchers, and EMS and EMSC treatment providers. Establishment of strong partnerships between researchers and emergency care practitioners is essential to assure that new treatments and systems management approaches address the critical needs of community and regional emergency medical services systems and are suitable for those settings. Through this joint effort, the gaps in current treatments and systems management approaches will be addressed, yielding treatments and systems approaches proven in real life emergency medical services systems ready for adoption into practices everywhere.

The overall goal of this project is to demonstrate the value of an infrastructure for collaborative research designed to foster the conduct of investigations on the efficacy of treatments, transport and care responses involved in emergency medical services for children, including those that precede the arrival of children to hospital emergency departments. Funding associated with this award is focused on supporting this infrastructure and not on funding specific research proposals. Awardees would be expected to seek extramural funding for studies conducted through PECARN.

The Emergency Medical Services for Children Network Development Demonstration Projects (EMSC-NDDP) cooperative agreements described in this announcement have been established to meet certain objectives. The intent is to demonstrate that: (1) a well conceived and fully operational infrastructure can be put in place to conduct high priority clinical trials and observational studies on EMSC, using rigorous study designs and methodologies; (2) a research and development process can be instituted within the network to develop proposals, conduct pilot studies, and carry out investigations with additional extramural funding; (3) a plan to study and encourage the transfer of network findings to EMSC practices can be designed and instituted; and (4) a collaboration of EMS personnel, nurses, practitioners and researchers can be fostered, to provide opportunities for bi-directional education and exchange of ideas, information and values between the treatment and academic communities.

Further information about prior activities conducted under PECARN can be found at the PECARN website at http://www.pecarn.org.

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The following describes multiple aspects of PECARN that applicants should consider in development of their application:

Organization and Functions

Research Node

The Research Node is the functional unit of PECARN. A Research Node consists of a Research Node Center (RNC) and multiple Hospital Emergency Department Affiliates (HEDAs). The RNC is to be the site of one of the HEDAs and there should be no more than two (2) HEDAs established by the RNC for a maximum of three (3) HEDAs per cooperative agreement. The RNC serves as the coordinating arm and maintains a research partnership with its HEDAs. This structure is depicted in the diagram below:

The RNC is the recipient of the cooperative agreement award. It is located in the Principal Investigator’s institution. The RNC provides a core of administrative and study operations services as well as scientific leadership and management of observational and randomized studies. The RNC, acting as the local operation center for the Research Node, has primary responsibility for: (1) establishing and maintaining a RNC infrastructure; (2) providing the HEDAs with administration and operations support; and (3) building partnerships with the HEDAs. The site of the RNC is also to be considered one of the HEDAs.

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Required functions of the RNC and HEDA sites for this application are detailed in Section II (Award InformationI).

PECARN Steering Committee

This committee constitutes the primary governing body of the PECARN network. The voting membership of the committee consists of the principal investigators of each Research Node, representatives from HEDAs and the principal investigator of the CDMCC. The steering committee will be responsible for overseeing the scientific aspects of the network. All steering committee decisions are reviewed by the HRSA program officer (PO). The PECARN steering committee follows established bylaws and standard operating procedures to govern the scientific aspects of the PECARN network. These are included in Appendix B of this FOA.

The PECARN steering committee will normally meet up to two (2) times per year. At least one meeting will be in the Washington DC metro area and another meeting in a major city in the US. The committee may meet more often via conference calls as needed.

PECARN Executive Committee

The PECARN executive committee consists of the principal investigator of the node, the principal investigator of the data center, and the HRSA Project Officer (PO). Nodal administrators from the funded nodes and the manager of the data center may be included in selected meetings.

The PECARN executive committee formulates and monitors policies and procedures guiding the research activities, reviews and approves procedures for data acquisition, analysis and management, oversees communication within the PECARN as well as with the greater scientific community and the public. They are also responsible for ensuring that there are well documented policies and operating procedures guiding all aspects of PECARN activities (e.g. protocol development, review, initiation, conduct, and closure, data collection, publication, etc.) and bylaws delineating the requirements and expectations of collaborating institutions, membership criteria, and standards of performance, and procedures for removing institutions due to poor performance. The Executive Committee establishes PECARN network performance goals and standards and monitor progress throughout the life of the PECARN and its research projects. The HRSA PO is a member of the Executive Committee and reviews all decisions to ensure they fall within the scope of the cooperative agreement.

The executive committee will meet at least monthly via teleconference and more often as needed. The committee will meet once in person in the Washington, DC area.

All participating Research Nodes and HEDAs must agree to abide by PECARN study designs and policies. It is important to note that research to be undertaken within the PECARN is not limited to research concepts contained within awardees applications, but will be determined by PECARN.

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Central Data Management and Coordinating Center (CDMCC)

HRSA has established a Central Data Management and Coordinating Center (CDMCC) under a separate cooperative agreement to provide PECARN Research Nodes with data collection, data management, data analysis guidelines, and to serve as a central repository for PECARN generated data. All RNC’s and associate HEDA’s agree to cooperate with the CDMCC by implementing PECARN-wide data standards for collection and analysis of data generated under the PECARN, and to provide the CDMCC timely data for purposes of monitoring the safety and progress of studies conducted under the PECARN. Research Nodes agree to provide the CDMCC final study data according to schedules developed and approved by the PECARN Steering Committee. All RNC’s and HEDA’s must agree to cooperate with the CDMCC to enable study monitoring and assure regulatory compliance and adherence to Good Clinical Practices (GCP) in all PECARN studies.

Quality Control and Monitoring

For protocols requiring an investigational new drug application (IND), the principal investigator or study specific sponsor is primarily responsible for study control and monitoring as defined by FDA rules and regulations. All participants under this award will cooperate with HRSA and the CDMCC to review RNC operations and advise investigators of specific requirements concerning investigational drug management.

With regards to laboratory quality control and data management issues, the RNC and HEDA sites agree to participate in protocol-defined measures to follow methodological and analytic guidelines established by the CDMCC or PECARN and HRSA.

Subject Safety/Oversight

The RNC and HEDA sites will adhere to protocol-specific measures established by the CDMCC to assure the safety and protection of the rights of volunteers who may participate in clinical trials and observational studies to be conducted as a result of this cooperative agreement.

Any project that may utilize human subjects or data from human subjects should consult their Institutional Review Board (IRB) or the federal Office of Human Research Protection (website: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) for the requirements of IRB review. The principal investigatorpi and all HEDA investigators assume and accept the primary responsibility for ensuring PECARN studies are conducted in compliance with all Federal regulations and PECARN policies and procedures.

All investigators agree and assure that adequate records will be maintained, and that access to these records will be available to enable outside monitors (including CDMCC staff) to assess compliance with applicable Federal laws and regulations.

Adverse Experience Reporting

The principal investigator of the Research Node agrees to implement and adhere to an adverse event tracking system operated by the CDMCC.

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Reporting RequirementsIn addition to the Reports described in this FOA (See Section VI. 3. Reports), the awardee agrees to furnish the following:

Protocol-Specific Reports: Awardees are required and agree to provide periodic reports of protocol-specific projects as requested by the CDMCC or HRSA. At a minimum, the Research Node must provide timely enrollment information in a format and according to a schedule defined by the CDMCC and/or the HRSA PO for all HEDA sites. Other protocol-specific reports, such as adverse event reports and other reports needed to monitor the safety and clinical effectiveness of drugs, treatments, or other interventions under investigation will be required to allow HRSA and the PECARN Steering Committee to monitor the research projects undertaken in the PECARN.

Investigational New Drug (IND) Reports: In regard to projects involving IND, awardees are required and agree to provide reports according to regulations and guidelines established by the Food and Drug Administration (FDA).

Data ConfidentialityPursuant to 42 USC 299c-3(c), information obtained in the course of any HRSA supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. PECARN and the CDMCC provides procedures for ensuring the confidentiality of the identifying information to be collected, including who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by awardees under this Funding will be managed in accordance with 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/ .

The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules, if applicable, and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) have published several implementation guides for this circular. They are: “An Introduction to Computer Security: The NIST Handbook”; “Generally Accepted Principals and Practices for Securing Information Technology Systems”; and the “Guide for Developing Security Plans for Information Technology Systems.” The circular and guides are available on the web at

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http://csrc.nist.gov/publications/nistpubs/800-12/ . The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in DataHRSA awardees may copyright, unless otherwise provided in the Notice of Award, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with HRSA funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable HRSA license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, HRSA purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.

Specific to data collected by PECARN, a de-identified dataset will be made available by the CDMCC three (3) years after the last patient completed the study or one (1) year after the primary manuscript for the study has been published, whichever comes sooner.

In addition, subject to HRSA budget constraints, final products may be made available to the health care community and the public by HRSA or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, HRSA publicizes research findings but relies on awardees to publish research results in peer-reviewed journals and to market grant-supported products.

All major PECARN policies and procedures are included in Appendix B of the FOA.

Publication of Data

Prompt and timely presentation and publication in the scientific literature of findings resulting from research undertaken in the PECARN is required. A primary publication from the research should be published no later than two (2) years after the last patient has been enrolled or data collection completed. Investigators must agree to abide by HRSA and PECARN policies concerning all publication of PECARN studies. Prior to the submission of manuscripts for publication Awardees agree to provide preprint copies to the HRSA Program Officer and PECARN steering committee. The publication policy is included in Appendix B.

HRSA’s Office of Communications will be consulted in advance of publication in order to coordinate announcements of new HRSA-supported research results with other HRSA dissemination activities.

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Acknowledgement of Funding Support:

As required by HHS appropriations acts, all HHS recipients must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal funds. Recipients are required to state: (1) the percentage and dollar amounts of the total program or project costs financed with Federal funds, and (2) the percentage and dollar amount of the total costs financed by non-governmental sources.

With respect to copyrightable material that might be developed as a part of the award activity, please note:

“that in accordance with 45 CFR 74.36, the HHS Grants Policy Statement provides that if any copyrightable material (e.g., audiovisuals, software, publications, curricula and training materials, etc.) is developed under this cooperative agreement (by the awardee or contractor) the Department of Health and Human Services (HHS) shall have a royalty-free nonexclusive and irrevocable right to reproduce, publish or otherwise use, and authorize others to use, the work, for purposes which further the objective of the Maternal and Child Health (MCH) program.”

All contracts or other arrangements entered into by the awardee for purpose of developing or procuring such material shall specifically reference and reserve the rights of HHS with respect to the material. The awardee shall provide a master electronic or digital file and four final reproducible copies of all such copyrightable material upon the request of the EMSC Program.

Review of Node and HEDA’s by HRSA

The HRSA Program Officer will monitor the performance of the Research Node participating in research under this cooperative agreement. Performance metrics for the node and HEDA sites such as budget execution, subject enrollment, data acquisition and transmission, and study analysis and reports will be will be reviewed and feedback provided to the RNC principal investigator.

The inability of a Research Node, including sub-recipient HEDA sites, to meet performance requirements and responsibilities may result in an adjustment of funding, withholding of support, restriction of funds already awarded, or suspension or termination of the award by HRSA.

Definitions and Abbreviated Terms

The following definitions and abbreviated terms are provided as guidance for applicants:

"Children" means youths from birth through age 21.

“CDMCC” Central Data Management and Coordinating Center. Serves as a central data collection, data management, data analysis, and repository for the Pediatric Emergency Care Applied Research Network.

“Cultural Competence ” means a set of values, behaviors, attitudes, and practices within a system, organization, or program or among individuals that enables them to work effectively

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cross culturally. Further, it refers to the ability to honor and respect the beliefs, language, interpersonal styles and behaviors of individuals and families receiving services, as well as staff who are providing such services. Cultural competence is a dynamic, ongoing, developmental process that requires a long-term commitment and is achieved over time.

"Emergency Medical Services" or "EMS" means services used in responding to an adult or child's need for immediate medical care in order to prevent loss of life and to prevent aggravation of physiological or psychological illness or injury and disability by appropriate intervention at the very early stages of the event.

"Emergency Medical Services System" means an arrangement of personnel, facilities, and equipment for the effective and coordinated delivery of health care services in an appropriate geographical area, under emergency conditions (occurring either as a result of the patient's condition or of natural disasters or similar situations), and which has the authority and the resources to provide effective administration of the system. An "appropriate geographical area" means an area which is of sufficient size, population, and economic diversity so that an efficient and economically feasible EMS project can be established, taking into consideration existing medical service areas and health service areas. The EMS system is a continuum encompassing primary prevention, pre-hospital and emergency department care, critical care and acute hospitalization, rehabilitation, and return to the community.

“EMSC-NDDP” – Emergency Medical Services for Children Network Development Demonstration Project. Demonstration project funded by HRSA to demonstrate the value of an infrastructure designed to be the platform from which to conduct observational and/or randomized studies related to emergency medical services for children.

"Family-Centered" includes the following key elements of care: maximum possible involvement of families in all phases of the EMSC continuum of care; clear and continuous communication between family members and the emergency care team; attention to the psychological needs of all family members; cultural competence of providers; consumer (parental) involvement in planning and needs assessment; organizational support for the formation of parent advocacy groups; and ongoing partnerships with such groups.

“HEDA” – Hospital Emergency Department Affiliate: Serves as a functional component of the Research Node, participates in the observational studies and randomized clinical trials and takes part in the development of and implementation of concept and protocol of these studies.

“PECARN” – Pediatric Emergency Care Applied Research Network: Functions as a collaborative group of Research Nodes funded by the cooperative agreement described within this funding opportunity announcement. PECARN is the operational name of the four research nodes (and their HEDAs) and the CDMCC. The successful applicants for this competition (EMSC-NDDP) will collectively be known as PECARN. The website http://www.pecarn.org denotes the current holders of these cooperative agreements as well as general information on current network activity.

“RNC” – Research Node Center: Serves as a recipient of the cooperative agreement award and a local operation center for the Research Node, provides a core of administrative and

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study operations services as well as scientific leadership and management of observational and randomized studies. One of the proposed HEDA sites should also be located at the RNC.

"State" means one of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of Northern Mariana Islands.

II. Award Information

1. Type of Award

Funding will be provided in the form of a cooperative agreement. A cooperative agreement, as opposed to a grant, is an award instrument of financial assistance where substantial involvement is anticipated between HRSA and the recipient during performance of the contemplated project.

In addition to the usual monitoring and technical assistance provided under the cooperative agreement, the EMSC Program responsibilities shall include:

1) Assurance of the availability of the services of HRSA personnel or designees to participate in the planning and development of all phases of PECARN;

2) Participation in meetings and seminars conducted during the period of the cooperative agreement including, but not limited to, executive committee calls, nodal administrator calls, executive committee meetings, and steering committee meetings;

3) Prior review of meeting agendas for any business conducted by the network; 4) Review of network policies and procedures established for carrying out project

activities;5) Review of research concepts, protocols or grant submissions prior to their

consideration before the full steering committee;6) Participation in periodic meetings and/or communications with the award recipients to

assess progress;7) Assistance in establishing and maintaining interagency and inter-organizational

contacts necessary to carry out the project;8) Participation in the dissemination of information about project activities; and9) Facilitation of effective communications and accountability to HRSA/MCHB

regarding the project with special attention to new program initiatives and policy development in the public health field relating to maternal and child health.

Requirements and Obligations of the cooperative agreement recipient include:

In addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, Department of Health and Human Services (HHS) Grant Administration regulations at 45 CFR Parts 74 and 92, and other HHS and HRSA Grants Administration policy statements, the specific recipient’s responsibilities are the following:

1) The RNC shall establish agreements with each HEDA that include, at a minimum; a. A statement of work defining the goals and objectives of the projects to be

undertaken under this cooperative agreement;

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b. A budget for support of the projects that clearly identifies the personnel, equipment, materials, and other costs required to successfully conduct high quality work according to the requirements of specific protocols approved for implementation by the PECARN steering committee;

c. A financial and program reporting requirement, including access to data and materials, to facilitate PECARN program operation and project oversight and monitoring; and

d. Each HEDA must have a reasonable and qualified investigator who agrees to fully cooperate with PECARN Steering committee, CDMCC, and MCHB to assure proper implementation of PECARN studies.

2) The RNC will provide HEDA’s with resources to ensure:a. Staff and training needed for the HEDAs to implement a study protocol; b. A training and monitoring system to ensure protocol-specific requirements; andc. Additional support such as quality control to ensure the successful completion

of the scientific goals of the research project. 3) Responsibilities of the HEDA sites include:

a. Agreement to participate in research studies approved by the PECARN steering committee;

b. Enroll adequate number of research participants required for specific studies; c. Agreement to provide routine clinical care to patients participating in protocols;d. Agreement to provide experimental/standard care in accordance with approved

research protocols; e. Maintain patient records and essential documents requirement for each protocol

and permit site monitors to examine those records;f. Collect clinical and laboratory data for research purposes, including biological

specimens when indicated;g. Cooperate with quality control activities and adhere to policies set by the

research node and the PECARN steering committee; h. Initiate and participate in the development of concepts and protocols of

observational studies and clinical trials to be conducted by the network;i. Agreement not to report data prior to collaborative reporting by PECARN;j. Have adequate information technology and information systems supported by

each site’s designated institutional staff;k. Agree to periodic on-site audits by representatives of it’s RNC, CDMCC,

HRSA (or designees) for use of treatments, compliance with protocol specifications, quality control and accuracy of data recording, and completeness of reporting of adverse reactions to treatments;

l. Agreement to adhere to good clinical practice (GCP) and other regulatory requirements concerning human subjects protections (including all Federal, institutional and PECARN defined policies and procedures);

m. Agreement to attend PECARN meetings;n. Participate in PECARN subcommittee and working groups;o. Participate in education training programs required for each study protocol;p. Collect and submit data in a timely manner in accordance with PECARN

steering committee, HRSA and CDMCC policies; q. Comply fully with all protocol requirements of each study;r. Demonstrate the ability and willingness to work cooperatively with HRSA,

other awardees, and the central data management and coordinating center, and

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to follow PECARN study protocols. Letters of agreement from participating HEDA sites should be included in Attachment 1.

2. Summary of Funding

This program will provide funding for Federal fiscal years 2011–2014. Approximately $630,000 is expected to be available annually to fund six (6) awardees for a total of $3,780,000. Applicants may apply for a ceiling amount of up to $630,000 per year (including direct and indirect costs). The period of support is four (4) years. Funding beyond the first year is dependent on the availability of appropriated funds for the EMSC Program in subsequent fiscal years, awardee satisfactory performance, and a decision that continued funding is in the best interest of the Federal government.

III. Eligibility Information

1. Eligible Applicants

Applications may be submitted by State governments and accredited schools of medicine. The term “school of medicine” for the purpose of this application funding opportunity announcement is defined as having the same meaning as set forth in section 799B(1)(A) of the Public Health Service Act (42 U.S.C. 295p(1)(A)) which defines it to mean an accredited public or nonprofit private school in the State that provides training leading, respectively, to a doctor of medicine and including advanced training related to such training provided by any such school. “The term accredited” in this context has the same meaning as set forth in section 799B(1)(E) of the Public Health Service Act (42 U.S.C. 295p(1)(E)) which when applied to a school of medicine defines it to mean a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education, except that a new school or program that, by reason of an insufficient period of operation, is not, at the time of application for a grant or contract under this subchapter, eligible for accreditation by such a recognized body or bodies, shall be deemed accredited for purposes of this subchapter, if the Secretary of Education finds, after consultation with appropriate accreditation body or bodies, that there is reasonable assurance that the school or program will meet the accreditation standards of such body or bodies prior to the beginning of the academic year following the normal graduation date of the first entering class in such school or program.

Applicants must have experience and demonstrable success in enrolling patients in the Emergency Department (ED) in both randomized intervention trials and observational studies.

2. Cost Sharing/Matching

Cost sharing or matching is NOT a requirement for this program.

3. Other

Applications that exceed the ceiling amount will be considered non-responsive and will not be considered for funding under this announcement.

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Any application that fails to satisfy the deadline requirements referenced in Section IV.3 will be considered non-responsive and will not be considered for funding under this announcement.

IV. Application and Submission Information

1. Address to Request Application Package

Application Materials and Required Electronic Submission InformationHRSA requires applicants for this funding opportunity announcement to apply electronically through Grants.gov. All applicants must submit in this manner unless they obtain a written exemption from this requirement in advance by the Director of HRSA’s Division of Grants Policy. Applicants must request an exemption in writing from DGPWaivers@hrsa.gov, and provide details as to why they are technologically unable to submit electronically through the Grants.gov portal. Your email must include the HRSA announcement number for which you are seeking relief, the name, address, and telephone number of the organization and the name and telephone number of the Project Director as well as the Grants.gov Tracking Number (GRANTXXXX) assigned to your submission along with a copy of the “Rejected with Errors” notification you received from Grants.gov. HRSA and its Grants Application Center (GAC) will only accept paper applications from applicants that received prior written approval. However, the application must still be submitted under the deadline.

Refer to HRSA’s Electronic Submission User Guide, available online at http://www.hrsa.gov/grants/userguide.htm for detailed application and submission instructions. Pay particular attention to Sections 2 and 5 that provide detailed information on the competitive application and submission process.

Applicants must submit proposals according to the instructions in the Guide and in this funding opportunity announcement in conjunction with Application Form SF-424. The forms contain additional general information and instructions for applications, proposal narratives, and budgets. The forms and instructions may be obtained from the following site by:

(1) Downloading from ,http://www.grants.gov or

(2) Contacting the HRSA Grants Application Center at:910 Clopper RoadSuite 155 SouthGaithersburg, MD 20878Telephone: 877-477-2123HRSAGAC@hrsa.gov

Specific instructions for preparing portions of the application that must accompany Application Form SF-424 appear in the “Application Format” section below.

2. Content and Form of Application Submission

Application Format Requirements

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The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA, or a total file size of 10 MB. This 80-page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support. Standard forms are NOT included in the page limit.

Applications that exceed the specified limits (approximately 10 MB, or 80 pages when printed by HRSA) will be deemed non-responsive. Non-responsive applications will not be considered under this funding announcement.

Application FormatApplications for funding must consist of the following documents in the following order:

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SF-424 Non Construction – Table of Contents

It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review.It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review. Failure to follow the instructions may make your application non-responsive. Non-responsive applications will not be considered under this funding Failure to follow the instructions may make your application non-responsive. Non-responsive applications will not be considered under this funding

opportunity announcement.opportunity announcement. For electronic submissions, applicants only have to number the electronic attachment pages sequentially, resetting the numbering for each For electronic submissions, applicants only have to number the electronic attachment pages sequentially, resetting the numbering for each

attachment, i.e., start at page 1 for each attachment. Do not attempt to number standard OMB approved form pages.attachment, i.e., start at page 1 for each attachment. Do not attempt to number standard OMB approved form pages. For electronic submissions, no Table of Contents is required for the entire application. HRSA will construct an electronic table of contents in the For electronic submissions, no Table of Contents is required for the entire application. HRSA will construct an electronic table of contents in the

order specified.order specified. When providing any electronic attachment with several pages, add a Table of Contents page specific to the attachment. Such pages will not be When providing any electronic attachment with several pages, add a Table of Contents page specific to the attachment. Such pages will not be

counted towards the page limit.counted towards the page limit.

Application Section Form Type Instruction HRSA/Program GuidelinesApplication for Federal Assistance (SF-424)

Form Pages 1, 2 & 3 of the SF-424 face page. Not counted in the page limit

Project Summary/Abstract Attachment Can be uploaded on page 2 of SF-424 - Box 15

Required attachment. Counted in the page limit. Refer to the funding opportunity announcement for detailed instructions.

Additional Congressional District Attachment Can be uploaded on page 3 of SF-424 - Box 16

As applicable to HRSA; not counted in the page limit.

Application Checklist Form HHS-5161-1

Form Pages 1 & 2 of the HHS checklist. Not counted in the page limit.

Project Narrative Attachment Form Form Supports the upload of Project Narrative document

Not counted in the page limit.

Project Narrative Attachment Can be uploaded in Project Narrative Attachment form.

Required attachment. Counted in the page limit. Refer to the funding opportunity announcement for detailed instructions. Provide table of contents specific to this document only as the first page.

SF-424A Budget Information - Non-Construction Programs

Form Page 1 & 2 to supports structured budget for the request of Non-construction related funds.

Not counted in the page limit.

Budget Narrative Attachment Form Form Supports the upload of Project Narrative document.

Not counted in the page limit.

Budget Narrative Attachment Can be uploaded in Budget Narrative Attachment form.

Required attachment. Counted in the page limit. Refer to the funding opportunity announcement for detailed instructions.

SF-424B Assurances - Non-Construction Programs

Form Supports assurances for non-construction programs.

Not counted in the page limit.

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Application Section Form Type Instruction HRSA/Program GuidelinesProject/Performance Site Location(s)

Form Supports primary and 29 additional sites in structured form.

Not counted in the page limit.

Additional Performance Site Location(s)

Attachment Can be uploaded in the SF-424 Performance Site Location(s) form. Single document with all additional site location(s)

Not counted in the page limit.

Disclosure of Lobbying Activities (SF-LLL)

Form Supports structured data for lobbying activities.

Not counted in the page limit.

Other Attachments Form Form Supports up to 15 numbered attachments. This form only contains the attachment list.

Not counted in the page limit.

Attachments 1-5 Attachment Can be uploaded in Other Attachments form 1-5.

Refer to the attachment table provided below for specific sequence. Counted in the page limit.

To ensure that attachments are organized and printed in a consistent manner, follow the order provided below. Note that these instructions may To ensure that attachments are organized and printed in a consistent manner, follow the order provided below. Note that these instructions may vary across programs.vary across programs.

Evidence of Non-Profit status and invention related documents, if applicable, must be provided in the other attachment form. Evidence of Non-Profit status and invention related documents, if applicable, must be provided in the other attachment form. Additional supporting documents, if applicable, can be provided using the available rows. Do not use the rows assigned to a specific purpose in theAdditional supporting documents, if applicable, can be provided using the available rows. Do not use the rows assigned to a specific purpose in the

program funding opportunity announcement.program funding opportunity announcement. Merge similar documents into a single document. Where several pages are expected in the attachment, ensure that you place a table of contents Merge similar documents into a single document. Where several pages are expected in the attachment, ensure that you place a table of contents

cover page specific to the attachment. The Table of Contents page will not be counted in the page limit.cover page specific to the attachment. The Table of Contents page will not be counted in the page limit.

Attachment Number Attachment Description (Program Guidelines)Attachment 1 Letters of Commitment from Participating HEDA’sAttachment 2 Biographical Sketches for Key PersonnelAttachment 3 Biographical Sketches for HEDA PI’sAttachment 4 Concept ProposalsAttachment 5 Other relevant documents

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Application Format

i. Application Face Page Complete Application Form SF-424 provided with the application package. Prepare according to instructions provided in the form itself. For information pertaining to the Catalog of Federal Domestic Assistance, the CFDA Number is 93.127.

DUNS NumberAll applicant organizations (and subrecipients of HRSA award funds) are required to have a Data Universal Numbering System (DUNS) number in order to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a unique nine-character identification number provided by the commercial company, Dun and Bradstreet. There is no charge to obtain a DUNS number. Information about obtaining a DUNS number can be found at http://fedgov.dnb.com/webform or call 1-866-705-5711. Please include the DUNS number in item 8c on the application face page. Applications will not be reviewed without a DUNS number. Note: A missing or incorrect DUNS number is the number one reason for applications being “Rejected for Errors” by Grants.gov.

Additionally, the applicant organization (and any subrecipient of HRSA award funds) is required to register annually with the Federal Government’s Central Contractor Registry (CCR) in order to do electronic business with the Federal Government. It is extremely important to verify that your CCR registration is active. Information about registering with the CCR can be found at http://www.ccr.gov.

ii. Table of ContentsThe application should be presented in the order of the Table of Contents provided earlier. Again, for electronic applications no table of contents is necessary as it will be generated by the system. (Note: the Table of Contents will not be counted in the page limit.)

iii. Application Checklist Complete the HHS Application Checklist Form HHS 5161-1 provided with the application package.

iv. BudgetComplete Application Form SF-424A Budget Information – Non-Construction Programs provided with the application package. Please complete Sections A, B, E, and F, and then provide a line item budget for each year of the project period using Section B Budget Categories of the SF-424A. Applicants must use the Section B columns (2) through (4) for subsequent budget years (up to four years).

v. Budget JustificationProvide a narrative that explains the amounts requested for each line in the budget. The budget justification should specifically describe how each item will support the achievement of proposed objectives. The budget period is for ONE year. However, the applicant must submit one-year budgets for each of the subsequent budget periods within the requested project period (usually one to four years) at the time of application. Line item information must be provided to explain the costs entered in Application Form SF-424. The budget

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justification must clearly describe each cost element and explain how each cost contributes to meeting the project’s objectives/goals. Be very careful about showing how each item in the “other” category is justified. For subsequent budget years, the justification narrative should highlight the changes from year one or clearly indicate that there are no substantive budget changes during the project period. The budget justification MUST be concise. Do NOT use the justification to expand the project narrative.

Budget for Multi-Year AwardThis announcement is inviting applications for project periods up to four (4) years. Awards, on a competitive basis, will be made for a one-year budget period; although the project period may be for up to four (4) years. Submission and HRSA approval of your Progress Report(s) and any other required submission or report is the basis for the budget period renewal and release of subsequent year funds. Funding beyond the one-year budget period but within the 4-year project period is subject to availability of funds, satisfactory progress of the awardee and a determination that continued funding would be in the best interest of the Federal government.

Include the following in the Budget Justification narrative:

Personnel Costs: Personnel costs should be explained by listing each staff member who will be supported from funds, name (if possible), position title, percentage of full-time equivalency, and annual salary.

The following guidelines are recommended for personnel costs based on past experience with PECARN:

The principal investigator (the applicant) should anticipate funding at a minimum of 20% Full Time Equivalent (FTE). The principal investigator can also serve as the site principal investigator for their HEDA site.

A nodal administrator at each RNC with adequate effort to support the activities of the node and PECARN administration.

Funding at 10% FTE for a HEDA principal investigator at the two (2) HEDA sites that are in addition to the RNC site.

A full-time (100%) Research Coordinator (RC) for each HEDA.

Each awardee will be expected to contribute to the leadership of the network by chairing subcommittees or serving as the chair or vice chair of the PECARN steering committee. It is recommended that each awardee budget an additional 5% of time for the nodal PI or a HEDA PI to serve in this role. There are 4 major PECARN subcommittees and 3 steering committee leadership positions so each awardee should budget for 1-2 leadership positions.

Fringe Benefits: List the components that comprise the fringe benefit rate, for example health insurance, taxes, unemployment insurance, life insurance, retirement plan, tuition reimbursement. The fringe benefits should be directly proportional to that portion of personnel costs that are allocated for the project.

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Travel: List travel costs according to local and long distance travel. For local travel, the mileage rate, number of miles, reason for travel and staff member/consumers completing the travel should be outlined. The budget should also reflect the travel expenses associated with participating in meetings and other proposed trainings or workshops.

In addition, the following travel is required to be budgeted.

Travel expenses associated with the nodal principal investigator, a representative from each HEDA, and a nodal administrator participating in up to two in-person Steering Committee meetings a year. At least one meeting will be held in the Washington metro area with an additional meeting in a major city in the US.

Travel expenses for the principal investigator and nodal administrator to travel to one executive committee meeting a year in the Washington, DC area. For budgeting purposes, this meeting can be combined with the EMSC annual meeting by adding two days to the EMSC annual meeting.

There may be Steering Committee meetings whose agenda includes information or training of importance to research coordinators. Thus at least one research coordinator from each site should be budgeted for travel twice a year for study related trainings.

The budget must include funds allocated for two individuals (the Principal investigator and another individual with a designated role in the project) to attend the EMSC program’s annual meeting. The EMSC award program requires attendance by the principal investigator and another individual with a designated role in the project (usually the nodal administrator). Please note that attendance at all days of this meeting is required.

Listed below are cost estimates that applicants may find helpful in preparing their application. Note: actual costs may vary slightly:

EMSC Annual Meeting

2012-2014: EMSC Annual Meeting Lodging: 3 nights @ $250 per night; Airfare travel to Washington, DC area

PECARN Steering Committee Meeting (up to 2 Steering Committee meetings per year for an anticipated total of 10 meetings during the cooperative agreement period of Sept 1, 2011 – August 30, 2015)

Lodging: 3 nights @ $250 per nightTravel: Airfare average of $600 per person depending upon meeting location.

At least one meeting per year will be held in the Washington, DC area.

Registration/Meeting Expenses: Each node should budget an estimated $5,000 per meeting (total of $10,000 per year) to cover PECARN meeting expenses such as room rental, AV costs etc.

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Meetings are coordinated by the EMSC National Resource Center and hotel meeting costs are invoiced to awardees.

It is also recommended that travel for presentation at scientific meetings be budgeted as appropriate.

Equipment: List equipment costs and provide justification for the need of the equipment to carry out the program’s goals. Extensive justification and a detailed status of current equipment must be provided when requesting funds for the purchase of computers and furniture items that meet the definition of equipment (a unit cost of $5000 or more and a useful life of one or more years).

Supplies: List the items that the project will use. In this category, separate office supplies from medical and educational purchases. Office supplies could include paper, pencils, and the like; medical supplies are syringes, blood tubes, plastic gloves, etc., and educational supplies may be pamphlets and educational videotapes. Remember, they must be listed separately.

Contractual: Applicants are responsible for ensuring that their organization or institution has in place an established and adequate procurement system with fully developed written procedures for awarding and monitoring all contracts. Applicants must provide a clear explanation as to the purpose of each contract, how the costs were estimated, and the specific contract deliverables. Reminder: recipients must notify their potential subrecipients that entities receiving subawards must provide the recipient with their DUNS number.

Note that contracts with HEDA sites should be listed in this section.

Consultants can also be listed in this section. For each consultant, specify the scope of work for the consultant, the hourly rate, and the number of hours of expected effort.

Other: Put all costs that do not fit into any other category into this category and provide an explanation of each cost in this category. In some cases, rent, utilities and insurance fall under this category if they are not included in an approved indirect cost rate.

Indirect Costs: Indirect costs are those costs incurred for common or joint objectives which cannot be readily identified but are necessary to the operations of the organization, e.g., the cost of operating and maintaining facilities, depreciation, and administrative salaries. For institutions subject to OMB Circular A-21, the term “facilities and administration” is used to denote indirect costs. If an organization applying for an assistance award does not have an indirect cost rate, the applicant may wish to obtain one through HHS’s Division of Cost Allocation (DCA).  Visit DCA’s website at http://rates.psc.gov/ to learn more about rate agreements, the process for applying for them, and the regional offices which negotiate them.

Please note that if indirect costs are requested, the applicant must submit a copy of the latest negotiated rate agreement. This project supports an infrastructure from which to conduct research, but is not a research project in and of itself, therefore, it is not eligible for research indirect rates. The indirect costs rate refers to the "Other Sponsored Program/Activities" rate and to neither the research rate, nor the education/training program rate. Those applicants

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without an established indirect cost rate for “other sponsored programs” may only request 10% of salaries and wages, and must request an “other sponsored programs” rate from DCA.

Direct cost amounts for equipment (capital expenditures), tuition and fees, and contracts in excess of $25,000 are excluded from the actual direct cost base for purposes of this calculation.

Note: HRSA/MCHB allows awardees to utilize contractors but not to issue subgrants.

vi. Staffing Plan and Personnel RequirementsApplicants must present a staffing plan and provide a justification for the plan that includes education and experience qualifications and rationale for the amount of time being requested for each staff position. Position descriptions that include the roles, responsibilities, and qualifications of proposed project staff must be included in the section titled “capabilities of the applicant”. Biographical sketches for any key employed personnel that will be assigned to work on the proposed project must be included in Attachment 2. In addition, biographical sketches for HEDA PI’s should be included in Attachment 3.

vii. AssurancesComplete Application Form SF-424B Assurances – Non-Construction Programs provided with the application package.

viii. CertificationsUse the Certifications and Disclosure of Lobbying Activities Application Form provided with the application package.

ix. Project AbstractProvide a summary of the application. Because the abstract is often distributed to provide information to the public and Congress, please prepare this so that it is clear, accurate, concise, and without reference to other parts of the application. It must include a brief description of the proposed project including the needs to be addressed, the proposed services, and the population group(s) to be served.

Please place the following at the top of the abstract: Project Title Applicant Name Address Contact Phone Numbers (Voice, Fax) E-Mail Address Web Site Address, if applicable

Abstract content:

PROBLEM: Briefly (in one or two paragraphs) state the principal needs and problems which are addressed by the project.

GOAL(S) AND OBJECTIVES: Identify the major goal(s) and objectives for the project period. Typically, the goal is stated in a sentence or paragraph, and the objectives are presented in a numbered list.

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METHODOLOGY: Describe the programs and activities used to attain the objectives and comment on innovation, cost, and other characteristics of the methodology. This section is usually several paragraphs long and describes the activities which have been proposed or are being implemented to achieve the stated objectives. Lists with numbered items are sometimes used in this section as well.

COORDINATION: Describe the coordination planned with appropriate national, regional, state and/or local health agencies and/or organizations in the area(s) served by the project.

EVALUATION: Briefly describe the evaluation methods used to assess program outcomes and the effectiveness and efficiency of the project in attaining goals and objectives. This section is usually one or two paragraphs in length.

ANNOTATION: Provide a three- to five-sentence description of your project that identifies the project’s purpose, the needs and problems, which are addressed, the goals and objectives of the project, the activities, which will be used to attain the goals and the materials which will be developed.

The project abstract must be single-spaced and limited to one page in length.

x. Program NarrativeThis section provides a comprehensive framework and description of all aspects of the proposed program. It should be succinct, self-explanatory and well organized so that reviewers can understand the proposed project.The project narrative should be structured in five (5) sections described below. Attachments may be used to provide supporting documentation, but substantive information corresponding to review criteria must be contained within the program narrative. The reviewers are required to evaluate a proposal based only upon the information provided in the application. Any other information may not be considered in the review. The project narrative should be responsive to the Review Criteria (See Section V. Review Criteria).

Please make special note of the requirements described in each of the sections below. Use the following section headers for the Project Narrative:

Section 1. Background and Significance

Section II. Specific Goals and Objectives

Section III. Capability of HEDA Sites

Section IV. Methods and Evaluation

Section V. Plan and Schedule of Implementation, and Capability of Applicant

Background and Significance - Section IIn this section, the applicant should demonstrate a thorough knowledge and understanding of multi-institute emergency care research. Identify issues of concern to and needs of those involved in the emergency care of children as it relates to improving care through evidence-based research. The applicant should demonstrate how multi-site research studies can address this issue. The applicant should provide a brief literature review that discusses the

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significance of the multi-institute research and demonstrates their understanding of high priority research needs in pediatric emergency care.

Specific Goals and Objectives – Section II

This section of the narrative should include a numbered list of the specific goals and objectives to be accomplished during the funding period. The specific objectives should be succinctly stated. The applicant should direct attention to the scope of expected activities listed below and earlier in the funding opportunity announcement.

Expected Activities for the RNC and HEDAs

The RNC agrees to identify and establish agreements with two (2) other Hospital Emergency Department Affiliates (HEDAs) to conduct projects under this cooperative agreement. Note: the site of the RNC will serve as one of the HEDA’s for a total of three (3) HEDAs.

The RNC shall establish agreements with each HEDA that include, at a minimum, 1) a statement of work defining the goals and objectives of the projects to be undertaken

under this cooperative agreement; 2) a budget for support of the projects that clearly identifies the personnel, equipment,

materials, and other costs required to successfully conduct high quality works according to the requirements of specific protocols approved for implementation by the PECARN Steering Committee;

3) a financial and program reporting requirement, including access to data and materials, to facilitate PECARN program operation and project oversight and monitoring; and

4) a requirement that each HEDA must have a responsible and qualified investigator who agrees to fully cooperate with the PECARN Steering Committee, CDMCC, and HRSA to assure proper implementation of PECARN studies.

The application should provide documentation in Attachment 1 (letters of agreement from HEDA principal investigators) of participation of two HEDAs (in addition to the RNC’s HEDA).

Responsibility Toward the Hospital Emergency Departments Affiliates (HEDAs):

The application should address how the RNC will manage HEDA sites.

The RNC provides the HEDAs with resources to ensure:

(1) staff and training needed for the HEDAs to implement a study protocol;

(2) training and monitoring to ensure adherence to protocol specific requirements; and

(3) additional support such as quality control to ensure the successful completion of the scientific goals of a research project.

Responsibility of Each HEDA Site:

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The site of the RNC is also to be considered one of the HEDAs. Each HEDA should:

1) Agree to participate in observational studies and controlled clinical trials, including randomization methods for assignment of patients to experimental or control groups or randomization of care delivered to different conditions;

2) Enroll adequate numbers of research participants required for specific studies; (see requirement in the next section to demonstrate historical success in enrollment)

3) Agree to provide routine clinical care to patients participating in protocols;

4) Agree to provide experimental/standard care in accord with approved research protocols;

5) Maintain patient records and essential documents required for each protocol and permit site monitors to examine those records;

6) Collect clinical and laboratory data, including biological specimens when indicated;

7) Cooperate with quality control activities and adhere to policies set by the Research Node and the PECARN Steering Commitee;

8) Participate in the development of concept and protocol of observational and clinical trials studies to be conducted by the Research Node;

9) Agree not to report data prior to collaborative reporting;

10) Provide adequate information technology and information systems support by each site’s designated institutional staff;

11) Agree to periodic on-site audits by representatives of its RNC, CDMCC, HRSA, or HRSA designee for use of treatments, compliance with protocol specifications, quality control and accuracy of data recording, and completeness of reporting of adverse reactions to treatments;

12) Agree to adhere to good clinical practice (GCP) and other regulatory requirements concerning clinical trials (including all Federal, institutional policies related to human subjects protections);

13) Agree to attend PECARN meetings. Applicants should include budgets for travel to these Steering Committee meetings in their application and should assure that adequate provisions are made to allow the Principal Investigator and HEDA representatives to participate fully in activities of the PECARN Steering Committee and its subcommittees/workgroups;.

14) Participate in subcommittees;

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15) Participate in educational training programs required for each study protocol;

16) Collect and submit data in a timely manner in accordance with PECARN Steering Committee and Central Data Management and Coordinating Center (CDMCC) policies;

17) Comply fully with protocol requirements for each study; and

18) Demonstrate their ability and willingness to work cooperatively with HRSA, other awardees, and the central data management and coordinating center, and to follow common study protocols. Letters of agreement from participating HEDA sites should be included in attachment 1.

Capability of HEDA Sites—Section IIIA significant portion of the review criteria is based on the ability to demonstrate historical success with conducting pediatric emergency medicine research and enrolling patients in interventional and observational studies.

The applicant should document their ability to conduct pediatric emergency medicine research by both:

1) Enrolling pediatric research participants for all HEDA sites (in both observational and interventional trials); and

2) Leading pediatric emergency medicine research (demonstrated by documenting notable publications of the HEDA PI and/or grants/contracts where the HEDA PI was the principal investigator or co-investigator).

The following information must be included for each HEDA site (including the RNC site):

1) Total number of pediatric ED visits at the HEDA site.2) Characteristics of pediatric ED visits (demographics, percent trauma versus medical,

and other available statistics).3) Structure of each HEDA site that facilitates ED research (for example, resources

available at the site such as electronic health records, presence of trained research personnel, or trauma center designation, etc that create a conducive environment to conduct research).

4) List of ED based studies that the HEDA site participated in the past 5 years that enrolled pediatric patients. For each study, provide a table that includes the following information:

a. Brief description of the study including study type (interventional versus observational)

b. Number of patients enrolled at the HEDA sitec. For multicenter studies: Percent of total patients enrolled at the HEDA site (i.e

number of patients enrolled at the HEDA site divided by total patients enrolled across all sites)

5) Qualifications and experience of the HEDA PI (including the RNC PI if they are serving as the HEDA PI). The following specific items should be included:

HRSA-11-079 26

a. Major publications of the HEDA PI that involved a pediatric emergency medicine research study. Note, a publications list can be provided in a biosketch. This section should highlight noteworthy publications.

b. Grants/contracts obtained by the HEDA PI to conduct pediatric emergency medicine studies. Note: a detailed list can be provided in the biosketch. This section should be used for noteworthy grants.

6) Procedures for obtaining Institutional Review Board (IRB) approval for PECARN research protocols. Include specific information on the frequency of IRB meetings and typical review times for study protocols at each HEDA site. Historical information for the amount of time needed to obtain IRB approval for the studies described above should be included.

Project Design: Methods and Evaluation – Section IV

This section of the narrative should provide detailed descriptions of the methodology for accomplishing each of the specific objectives. Specific activities and tasks should be detailed.

An organizational chart to describe the functional structure for involving appropriate RNC and HEDA personnel in the design and implementation of a variety of treatments or services should be provided. An organizational chart and a description of the RNC operation should describe the relationship between the research, clinical practices, and administrative functional units within the Research Node.

In each of these areas, it is crucial that the applicant describe how the health providers and/or researchers will function in true partnership with the RNC in terms of study origination, design, execution and administration. Applicants should anticipate potential problems and challenges that may arise in this process, and propose mechanisms for collaborative resolution among the Research Node participants.

One important aspect of successful participation in PECARN is the ability to generate research ideas and proposals. Applicants should identify a process that will be used with the RNC and HEDA sites to generate and review research ideas generated in the node. As a demonstration of the applicant’s ability to generate such ideas, two concept proposals should be submitted in Attachment 4. The concept proposal should be no more than two (2) pages in length and address the following;

Significance of the topic Specific objectives Research methods (study design, statistical sampling frame and plan for

evaluation) Funding Plan (identify where an external grant application may be submitted to

fund the proposal).

Note: these concept proposals are a demonstration of ability only. Implementation of these ideas will need to follow applicable PECARN bylaws (included in Appendix B of this funding opportunity announcement).

HRSA-11-079 27

Evaluation: For each described objective, an evaluation measure should be included. The evaluation measure should be measurable and a timeline for evaluation should be presented consistent with the plan and schedule of implementation for the goals and objectives.

The applicant is encouraged to list and discuss anticipated obstacles that may be encountered in conducting research and how each obstacle will be overcome. Specifically, applicants should discuss how they will monitor HEDA site performance and include plans for assisting sites experiencing challenges

In addition, the evaluation should include an effective publication and dissemination plan for research studies that the node leads.

Plan and Schedule of Implementation, and Capability of the Applicant – Section V

In this section of the narrative, the applicant should provide a description of the organizational plan for management of the project, including an explanation of the roles and responsibilities of project personnel, project collaborators, and consultants.

The applicant should describe the capability of the RNC investigator in leading the node and the responsibilities of all personnel. Note: information provided about the RNC as a HEDA site in Section III does not need to be repeated. This section should focus on the ability of the RNC to serve as a coordinating node and of the principal investigator of this application to provide leadership to the node and to PECARN.

In addition, an implementation schedule should be provided for each activity described in previous sections. The material should be presented in a succinct manner, with a brief listing of specific milestones and expected outcomes.

xi. Program Specific Forms

1) Performance Standards for Special Projects of Regional or National Significance (SPRANS) and Other MCHB Discretionary Projects

The Health Resources and Services Administration (HRSA) has modified its reporting requirements for SPRANS projects, Community Integrated Service Systems (CISS) projects, and other grant programs administered by the Maternal and Child Health Bureau (MCHB) to include national performance measures that were developed in accordance with the requirements of the Government Performance and Results Act (GPRA) of 1993 (Public Law 103-62). This Act requires the establishment of measurable goals for Federal programs that can be reported as part of the budgetary process, thus linking funding decisions with performance. Performance measures for States have also been established under the Block Grant provisions of Title V of the Social Security Act, the MCHB’s authorizing legislation. Performance measures for other MCHB-funded grant programs have been approved by the Office of Management and Budget and are primarily based on existing or administrative data

HRSA-11-079 28

that projects should easily be able to access or collect. An electronic system for reporting these data elements has been developed and is now available.

2) Performance Measures for the EMSC Program and Submission of Administrative Data

To prepare applicants for reporting requirements, administrative data collection requirements are presented in the appendices of this funding opportunity announcement.

xii. Attachments Please provide the following items to complete the content of the application. Please note that these are supplementary in nature, and are not intended to be a continuation of the project narrative. Each attachment must be clearly labeled.

Please provide the following items to complete the content of the application. Please note that these are supplementary in nature, and are not intended to be a continuation of the project narrative. Be sure each attachment is clearly labeled.

Required Attachments: Note: these are counted in the page limit.

Attachement 1: Letters of Commitment from HEDA SitesProvide letter of agreement from each HEDA site that include their agreement to participate as outlined in this funding opportunity announcement. Letters of agreements must be dated.

Attachment 2: Biographical sketches for key personnelInclude biographical sketches for persons occupying the key positions at the RNC, not to exceed two pages in length. For persons who are not yet hired but named as key personnel, include a position description.

Attachment 3: Biographical sketches for HEDA PI’sInclude biographical sketches the HEDA principal investigators, not to exceed two pages in length.

Attachment 4: Concept ProposalsInclude at least two (2) concept proposals that demonstrate the ability of the applicant to generate such ideas, two concept proposals should be submitted in Attachment 4. The concept proposal should be no more than two (2) pages in length and address the following;

Significance of the topic Specific objectives Research methods (study design, statistical sampling frame and plan for

evaluation) Funding Plan (identify where a grant application may be submitted to fund the

proposal).

Attachment 5: Other relevant documents.

Other Attachments:

HRSA-11-079 29

Applicants may provide additional attachments to complete the content of the application. Please note that these are supplementary in nature, and are not intended to be a continuation of the project narrative. Such additional attachments will count toward the 80-page application limit. Label each cleary. Examples of other attachments include;

Tables, Charts, etc. to give further details about the proposal. Bibliography of published or accepted manuscripts that demonstrate the applicant’s

involvement in multicenter trials. Additional letters of support. Include only letters of support which specifically indicate

a commitment to the project/program (in-kind services, dollars, staff, space, equipment, etc.) Letters of agreement and support must be dated. All other letters of support can be summarized or listed on one page. These letters may be requested by the Program at any time but do not need to be included in the application.

3. Submission Dates and Times

Notification of Intent to Apply An applicant is eligible to apply even if no letter of intent is submitted. The letter should identify the applicant organization and its intent to apply, and briefly describe the proposal to be submitted. Receipt of Letters of Intent will not be acknowledged.

This letter should be sent by February 15, 2011 by mail or fax to:

Director, Division of Independent ReviewHRSA Grants Application Center (GAC)HRSA-11-079910 Clopper Road, Suite 155 SouthGaithersburg, MD 20878Fax: (877) 477-2345

Application Due Date The due date for applications under this funding opportunity announcement is March 16, 2011 at 8:00 P.M. ET. Applications completed online are considered formally submitted when the application has been successfully transmitted electronically by your organization’s Authorized Organization Representative (AOR) through Grants.gov and has been validated by Grants.gov on or before the deadline date and time.  

The Chief Grants Management Officer (CGMO) or designee may authorize an extension of published deadlines when justified by circumstances such as natural disasters (e.g., floods or hurricanes) or other disruptions of services, such as a prolonged blackout. The CGMO or designee will determine the affected geographical area(s).

Late applications: Applications which do not meet the criteria above are considered late applications and will not be considered in the current competition.

4. Intergovernmental Review

HRSA-11-079 30

The Emergency Medical Services for Children Program is not a program subject to the provisions of Executive Order 12372, as implemented by 45 CFR 100.

5. Funding Restrictions

Applicants responding to this announcement may request funding for a project period of up to four (4) years, at no more than $630,000 per year. Awards to support projects beyond the first budget year will be contingent upon Congressional appropriation, satisfactory progress in meeting the project’s objectives, and a determination that continued funding would be in the best interest of the Federal government.

6. Other Submission Requirements

As stated in Section IV.1, except in rare cases HRSA will no longer accept applications in paper form. Applicants submitting for this funding opportunity are required to submit electronically through Grants.gov. To submit an application electronically, please use the http://www.Grants.gov apply site. When using Grants.gov you will be able to download a copy of the application package, complete it off-line, and then upload and submit the application via the Grants.gov site.

It is essential that your organization immediately register in Grants.gov and become familiar with the Grants.gov site application process. If you do not complete the registration process you will be unable to submit an application. The registration process can take up to one month.

To be able to successfully register in Grants.gov, it is necessary that you complete all of the following required actions:

• Obtain an organizational Data Universal Number System (DUNS) number• Register the organization with Central Contractor Registry (CCR)• Identify the organization’s E-Business Point of Contact (E-Biz POC)• Confirm the organization’s CCR “Marketing Partner ID Number (M-PIN)” password• Register an Authorized Organization Representative (AOR)• Obtain a username and password from the Grants.gov Credential Provider

Instructions on how to register, tutorials and FAQs are available on the Grants.gov web site at http://www.grants.gov. Assistance is also available 24 hours a day, 7 days a week (excluding Federal holidays) from the Grants.gov help desk at support@grants.gov or by phone at 1-800-518-4726.

Formal submission of the electronic application: Applications completed online are considered formally submitted when the application has been successfully transmitted electronically by your organization’s AOR through Grants.gov and has been validated by Grants.gov on or before the deadline date and time.  

It is incumbent on applicants to ensure that the AOR is available to submit the application to HRSA by the published due date. HRSA will not accept submission or re-submission of incomplete, rejected, or otherwise delayed applications after the deadline. Therefore, you are urged to submit your application in advance of the deadline. If your application is rejected

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by Grants.gov due to errors, you must correct the application and resubmit it to Grants.gov before the deadline date and time.

If, for any reason, an application is submitted more than once prior to the application due date, HRSA will only accept the applicant’s last electronic submission prior to the application due date as the final and only acceptable submission of any competing application submitted to Grants.gov.

Tracking your application: It is incumbent on the applicant to track application status by using the Grants.gov tracking number (GRANTXXXXXXXX) provided in the confirmation email from Grants.gov. More information about tracking your application can be found at http://www07.grants.gov/applicants/resources.jsp.

V. Application Review Information

1. Review Criteria

Procedures for assessing the technical merit of applications have been instituted to provide for an objective review of applications and to assist the applicant in understanding the standards against which each application will be judged. Critical indicators have been developed for each review criterion to assist the applicant in presenting pertinent information related to that criterion and to provide the reviewer with a standard for evaluation. Review criteria are outlined below with specific detail and scoring points.

Review Criteria are used to review and rank applications. The EMSC Program has six (6) review criteria:

Criterion 1: NEED (5 points)The extent to which the application describes the need for and challenges in pediatric emergency medicine research and the associated contributing factors. In addition, the extent to which the applicant identifies high priority areas for pediatric emergency medicine research.

Criterion 2: CAPABILITY OF THE HEDAs (40 points)The extent to which the chosen HEDAs for this application have experience and proven success in enrolling children in Emergency Department (ED) based trials. Proven success should be demonstrated in the application by: 1) explicitly written prior record that shows that each selected HEDA site enrolled a high percentage of children in previous trials, particularly multicenter trials; and 2) HEDA site PI qualifications demonstrate success in leading pediatric emergency medicine trials through publications and previously successful grant applications.

Criterion 3: CAPABILITY OF THE RNC (15 points)The extent to which the RNC infrastructure, including the qualifications of the RNC PI and organization will; 1) ensure successful enrollment of patients in research studies across all HEDAs in the node; 2) contribute new research ideas to PECARN; 3) have the experience to

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bring external funding to PECARN for specific research studies; and 4) provide leadership to the PECARN.

Criterion 4: RESPONSE (20 points)The extent to which the proposed project responds to the “Purpose” included in the program description. The quality of the research ideas/concepts submitted by the applicant. The clarity of the proposed goals and objectives and their relationship to the identified project. The extent to which the activities (scientific or other) described in the application are capable of addressing the problem and attaining the project objectives.

Criterion 5: EVALUATIVE MEASURES (10 points)The effectiveness of the method proposed to monitor and evaluate the success of the RNC and HEDA sites in enrolling patients in studies, contributing new research ideas to PECARN, and writing grants to bring external funding for specific PECARN studies. The extent to which the application clearly identifies a continuous monitoring plan for HEDA performance and a strategy for remediating HEDA’s that do not meet performance metrics.

Criterion 6: SUPPORT REQUESTED (10 points)The reasonableness of the proposed budget is adequate to meet stated goals and objectives.

2. Review and Selection Process

The Division of Independent Review is responsible for managing objective reviews within HRSA. Applications competing for Federal funds receive an objective and independent review performed by a committee of experts qualified by training and experience in particular fields or disciplines related to the program being reviewed. In selecting review committee members, other factors in addition to training and experience may be considered to improve the balance of the committee, e.g., geographic distribution. Each reviewer is screened to avoid conflicts of interest and is responsible for providing an objective, unbiased evaluation based on the review criteria noted above. The committee provides expert advice on the merits of each application to program officials responsible for final selections for award.

Applications that pass the initial HRSA eligibility screening will be reviewed and rated by a panel based on the program elements and review criteria presented in relevant sections of this program announcement. The review criteria are designed to enable the review panel to assess the quality of a proposed project and determine the likelihood of its success. The criteria are closely related to each other and are considered as a whole in judging the overall quality of an application.

3. Anticipated Announcement and Award Dates

It is anticipated that awards will be announced prior to the start date of September 1, 2011.

HRSA-11-079 33

VI. Award Administration Information

1. Award Notices

Each applicant will receive written notification via e-mail of the outcome of the objective review process, including a summary of the expert committee’s assessment of the application’s merits and weaknesses, and whether the application was selected for funding. Applicants who are selected for funding may be required to respond in a satisfactory manner to Conditions placed on their application before funding can proceed. Letters of notification do not provide authorization to begin performance.

The Notice of Award sets forth the amount of funds granted, the terms and conditions of the award, the effective date of the award, the budget period for which initial support will be given, the non-Federal share to be provided (if applicable), and the total project period for which support is contemplated. Signed by the Grants Management Officer, it is sent via e-mail to the applicant’s Authorized Organization Representative, and reflects the only authorizing document. It will be sent prior to the start date of September 1, 2011.

2. Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Commercial Organizations or 45 CFR Part 92 Uniform Administrative Requirements For Grants And Cooperative Agreements to State, Local, and Tribal Governments, as appropriate.

HRSA grant and cooperative agreement awards are subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable based on recipient type and purpose of award. This includes, as applicable, any requirements in Parts I and II of the HHS GPS that apply to the award. The HHS GPS is available at http://www.hrsa.gov/grants/. The general terms and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award-specific requirements to the contrary (as specified in the Notice of Award).

Cultural and Linguistic CompetenceHRSA is committed to ensuring access to quality health care for all. Quality care means access to services, information, materials delivered by competent providers in a manner that factors in the language needs, cultural richness, and diversity of populations served. Quality also means that, where appropriate, data collection instruments used should adhere to culturally competent and linguistically appropriate norms. For additional information and guidance, refer to the National Standards for Culturally and Linguistically Appropriate Services in Health Care published by HHS. This document is available online at http://www.omhrc.gov/CLAS.

Trafficking in PersonsAwards issued under this funding opportunity announcement are subject to the requirements of Section 106 (g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104). For the full text of the award term, go to http://www.hrsa.gov/grants/trafficking.html.

HRSA-11-079 34

If you are unable to access this link, please contact the Grants Management Specialist identified in this funding opportunity to obtain a copy of the Term.

PUBLIC POLICY ISSUANCE

HEALTHY PEOPLE 2020 is a national initiative led by HHS that sets priorities for all HRSA programs. The initiative has two major goals: (1) to increase the quality and years of a healthy life; and (2) eliminate our country’s health disparities. The program consists of 38 focus areas containing measurable objectives. HRSA has actively participated in the work groups of all the focus areas, and is committed to the achievement of the Healthy People 2020 goals.

More information about Healthy People 2020 may be found online at http://www.healthypeople.gov/.

National HIV/AIDS Strategy (NHAS)The new National HIV/AIDS Strategy (NHAS) has three primary goals: 1) reducing the number of people who become infected with HIV, 2) increasing access to care and optimizing health outcomes for people living with HIV, and 3) reducing HIV-related health disparities. The NHAS states that more must be done to ensure that new prevention methods are identified and that prevention resources are more strategically deployed. Further, the NHAS recognizes the importance of getting people with HIV into care early after infection to protect their health and reduce their potential of transmitting the virus to others. HIV disproportionately affects people who have less access to prevention and treatment services and, as a result, often have poorer health outcomes. Therefore, the NHAS advocates adopting community-level approaches to reduce HIV infection in high-risk communities and reduce stigma and discrimination against people living with HIV.

To ensure success, the NHAS requires the Federal government and State, tribal and local governments to increase collaboration, efficiency, and innovation. Therefore, to the extent possible, program activities should strive to support the three primary goals of the National HIV/AIDS Strategy.

More information can be found at http://www.whitehouse.gov/administration/eop/onap/nhas.

Smoke-Free WorkplaceThe Public Health Service strongly encourages all award recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. Further, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children.

3. Reporting

The successful applicant under this funding opportunity announcement must comply with the following reporting and review activities:

HRSA-11-079 35

a. Audit RequirementsComply with audit requirements of Office of Management and Budget (OMB) Circular A-133. Information on the scope, frequency, and other aspects of the audits can be found on the Internet at http://www.whitehouse.gov/omb/circulars_default.

b. Payment Management RequirementsSubmit a quarterly electronic Federal Financial Report (FFR) Cash Transaction Report via the Payment Management System.  The report identifies cash expenditures against the authorized funds for the grant or cooperative agreement. The FFR Cash Transaction Reports must be filed within 30 days of the end of each calendar quarter. Failure to submit the report may result in the inability to access award funds. Go to www.dpm.psc.gov for additional information.

c. Status Reports1) Federal Financial Report. The Federal Financial Report (SF-425) is required within 90 days of the end of each budget period. The report is an accounting of expenditures under the project that year. Financial reports must be submitted electronically through EHB. More specific information will be included in the Notice of Award.

2) Progress Report(s). The awardee must submit a progress report to HRSA on an annual basis.  Submission and HRSA approval of your Progress Report(s) triggers the budget period renewal and release of subsequent year funds. This report has two parts. The first part demonstrates awardee progress on program-specific goals.  The second part collects core performance measurement data including performance measurement data to measure the progress and impact of the project. Further information will be provided in the award notice.

3) Final Report(s). A final report is due within 90 days after the project period ends. The final report collects program-specific goals and progress on strategies; core performance measurement data; impact of the overall project; the degree to which the awardee achieved the mission, goal and strategies outlined in the program; awardee objectives and accomplishments; barriers encountered; and responses to summary questions regarding the awardee’s overall experiences over the entire project period.  The final report must be submitted on-line by awardees in the Electronic Handbooks system at https://grants.hrsa.gov/webexternal/home.asp

4) Performance Reports. The Health Resources and Services Administration (HRSA) has modified its reporting requirements for SPRANS projects, CISS projects, and other grant programs administered by the Maternal and Child Health Bureau (MCHB) to include national performance measures that were developed in accordance with the requirements of the Government Performance and Results Act (GPRA) of 1993 (Public Law 103-62). This Act requires the establishment of measurable goals for Federal programs that can be reported as part of the budgetary process, thus linking funding decisions with performance. Performance measures for States have also been established under the Block Grant provisions of Title V of the Social Security Act, the MCHB’s authorizing legislation. Performance measures for other MCHB-funded grant programs have been approved by the Office of Management and Budget and are primarily based on existing or administrative data that projects should easily be able to access or collect.

HRSA-11-079 36

i. Performance Measures and Program DataTo prepare applicants for these reporting requirements, the designated performance measures for this program and other program data collection are presented in the appendices of this funding opportunity announcement.

ii. Performance ReportingSuccessful applicants receiving grant funds will be required, within 120 days of the Notice of Award (NoA), to register in HRSA’s Electronic Handbooks (EHBs) and electronically complete the program specific data forms that appear in the appendices of this funding opportunity announcement. This requirement entails the provision of budget breakdowns in the financial forms based on the grant award amount, the project abstract and other grant summary data as well as providing objectives for the performance measures.

Performance reporting is conducted for each grant year of the project period. Awardees will be required, within 120 days of the NoA, to enter HRSA’s EHBs and complete the program specific forms. This requirement includes providing expenditure data, finalizing the abstract and grant summary data as well as finalizing indicators/scores for the performance measures.

iii. Project Period End Performance ReportingSuccessful applicants receiving grant funding will be required, within 90 days from the end of the project period, to electronically complete the program specific data forms that appear in the appendices of this funding opportunity announcement. The requirement includes providing expenditure data for the final year of the project period, the project abstract and grant summary data as well as final indicators/scores for the performance measures.

d. Transparency Act Reporting RequirementsNew awards issued under this funding opportunity announcement are subject to the reporting requirements of the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109–282), as amended by section 6202 of Public Law 110–252 and implemented by 2 CFR Part 170. Grant and cooperative agreement recipients must report information for each first-tier subaward of $25,000 or more in Federal funds and executive total compensation for the recipient’s and subrecipient’s five most highly compensated executives as outlined in Appendix A to 2 CFR Part 170 (available online at http://www.hrsa.gov/grants/ffata.html). Competing Continuation awardees may be subject to this requirement and will be so notified in the Notice of Award.

VII. Agency Contacts

Applicants may obtain additional information regarding business, administrative, or fiscal issues related to this funding opportunity announcement by contacting:

Ms. Thais Diaz-Macaluso

HRSA-11-079 37

Grants Management SpecialistHRSA Division of Grants Management OperationsParklawn Building, Room 11A-025600 Fishers LaneRockville, Maryland 20857Phone: (301) 443-0682Email: TDiaz-macaluso@hrsa.gov

Additional information related to the overall program issues and/or technical assistance regarding this funding announcement may be obtained by contacting

Tasmeen Weik, DrPHPublic Health AnalystMaternal and Child Health BureauParklawn Building, Room 18A-385600 Fishers LaneRockville, MD 20857 Telephone: (301) 443-8927Email: tweik@hrsa.gov

Applicants may need assistance when working online to submit their application forms electronically. For assistance with submitting the application in Grants.gov, contact Grants.gov 24 hours a day, seven days a week, excluding Federal holidays at:

Grants.gov Contact CenterPhone: 1-800-518-4726E-mail: support@grants.gov

VIII. Other Information

Refer to sections I and II of this funding opportunity announcement.

IX. Tips for Writing a Strong Application

A concise resource offering tips for writing proposals for HHS grants and cooperative agreements can be accessed online at: http://www.hhs.gov/asrt/og/grantinformation/apptips.html.

Technical Assistance CallA technical assistance call to answer questions related to this funding opportunity announcement will be held on January 24 at 12:00pm ET. To access the call and online web demonstration, please follow directions below. To Join the Phone Conference: Phone Number (Long Distance):   877-355-6338

HRSA-11-079 38

Enter 1 to attend meeting.Enter Meeting ID: 1234

Tip – Always mute your line when you are not speaking to reduce distractions.  Press #5 to mute and #5 to un-mute.

TO ATTEND THE WEB CONFERENCE:

* please follow instructions above to join the audio portion*

1. Go to: https://meetingplace.cnmc.org/a/19c00cc9e21424d0f2ddd97778ea68a4 2. Sign in as a Guest  and click on Attend Meeting.    - Accept any security warnings you receive and wait for the Meeting Room to initialize. 3. Click on CONNECT 

* NOTE: do not check the option to have the system call you. Uncheck the box before connecting*  TEST YOUR BROWSER BEFORE YOU ATTEND YOUR FIRST WEB CONFERENCE Visit https://meetingplace.cnmc.org/test/ to test your web browser for compatibility with the web conference.

HRSA-11-079 39

Appendix A: MCHB Administrative Forms and Performance Measures

The following Administrative Forms and Performance Measures are assigned to this MCHB program. Form 1, MCHB Project Budget Details Form 2, Project Funding Profile Form 4, Project Budget and Expenditures by Types of Services—(Use

Infrastructure Building for this Application) Form 6, MCH Abstract Form 7, Discretionary Grant Project Summary Data Performance Measures 03, The percentage of MCHB-funded projects

submitting and publishing findings in peer-reviewed journals Performance Measure 10, The degree to which MCHB-funded programs

have incorporated cultural and linguistic competence elements into their policies, guidelines, contracts and training

Performance Measure 24,The degree to which MCHB-funded initiatives contribute to infrastructure development through core public health assessment, policy development and assurance functions

Performance Measure 27, The degree to which awardees have mechanisms in place to ensure quality in the design, development, and dissemination of new information resources that they produce each year

Performance Measure 33, The degree to which MCHB-funded initiatives work to promote sustainability of their programs or initiatives beyond the life of MCHB funding

Data Forms: Products, Publications and Submissions Data Collection Form

HRSA-11-079 40

OMB No. 0915-0298Expiration Date: 10/31/2012

FORM 1MCHB PROJECT BUDGET DETAILS FOR FY _______

1. MCHB GRANT AWARD AMOUNT $2. UNOBLIGATED BALANCE $3. MATCHING FUNDS

(Required: Yes [ ] No [ ] If yes, amount)$

A. Local fundsB. State funds $C. Program Income $D. Applicant/Grantee Funds $E. Other funds:

$

4. OTHER PROJECT FUNDS (Not included in 3 above) $A. Local funds $B. State funds $C. Program Income (Clinical or Other) $D. Applicant/Grantee Funds (includes in-kind) $E. Other funds (including private sector, e.g., Foundations) $

5. TOTAL PROJECT FUNDS (Total lines 1 through 4) $6. FEDERAL COLLABORATIVE FUNDS

(Source(s) of additional Federal funds contributing to the project)$

A. Other MCHB Funds (Do not repeat grant funds from Line 1)1) Special Projects of Regional and National Significance (SPRANS) $2) Community Integrated Service Systems (CISS) $3) State Systems Development Initiative (SSDI) $4) Healthy Start $5) Emergency Medical Services for Children (EMSC) $6) Traumatic Brain Injury $7) State Title V Block Grant $8) Other: $9) Other: $10) Other:

$

B. Other HRSA Funds1) HIV/AIDS $2) Primary Care $3) Health Professions $4) Other: $5) Other: $6) Other: $

C. Other Federal Funds1) Center for Medicare and Medicaid Services (CMS) $2) Supplemental Security Income (SSI) $3) Agriculture (WIC/other) $

HRSA-11-079 41

OMB No. 0915-0298Expiration Date: 10/31/2012

4) Administration for Children and Families (ACF) $5) Centers for Disease Control and Prevention (CDC) $6) Substance Abuse and Mental Health Services Administration (SAMHSA)

$

7) National Institutes of Health (NIH) $8) Education $9) Bioterrorism10) Other:

$

11) Other:

$

12) Other $7. TOTAL COLLABORATIVE FEDERAL FUNDS $

HRSA-11-079 42

OMB No. 0915-0298Expiration Date: 10/31/2012

INSTRUCTIONS FOR COMPLETION OF FORM 1

MCH BUDGET DETAILS FOR FY ____

Line 1. Enter the amount of the Federal MCHB grant award for this project.

Line 2. Enter the amount of carryover (e.g, unobligated balance) from the previous year’s award, if any. New awards do not enter data in this field, since new awards will not have a carryover balance.

Line 3. If matching funds are required for this grant program list the amounts by source on lines 3A through 3E as appropriate. Where appropriate, include the dollar value of in-kind contributions.

Line 4. Enter the amount of other funds received for the project, by source on Lines 4A through 4E, specifying amounts from each source. Also include the dollar value of in-kind contributions.

Line 5. Displays the sum of lines 1 through 4.

Line 6. Enter the amount of other Federal funds received on the appropriate lines (A.1 through C.12) other than the MCHB grant award for the project. Such funds would include those from other Departments, other components of the Department of Health and Human Services, or other MCHB grants or contracts.

Line 6C.1. Enter only project funds from the Center for Medicare and Medicaid Services. Exclude Medicaid reimbursement, which is considered Program Income and should be included on Line 3C or 4C.

If lines 6A.8-10, 6B .4-6, or 6C.10-12 are utilized, specify the source(s) of the funds in the order of the amount provided, starting with the source of the most funds. .

Line 7. Displays the sum of lines in 6A.1 through 6C.12.

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OMB No. 0915-0298Expiration Date: 10/31/2012

FORM 2PROJECT FUNDING PROFILE

FY_____ FY_____ FY_____ FY_____ FY_____

Budgeted

Expended

Budgeted

Expended

Budgeted

Expended

Budgeted

Expended

Budgeted

Expended

1 MCHB GrantAward AmountLine 1, Form 2 $ $ $ $ $ $ $ $ $ $

2 Unobligated Balance Line 2, Form 2 $ $ $ $ $ $ $ $ $ $

3 Matching Funds(If required) Line 3, Form 2 $ $ $ $ $ $ $ $ $ $

4 Other Project Funds Line 4, Form 2 $ $ $ $ $ $ $ $ $ $

5 Total Project Funds Line 5, Form 2 $ $ $ $ $ $ $ $ $ $

6 Total Federal Collaborative

$ $ $ $ $ $ $ $ $ $

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Funds Line 7, Form 2

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INSTRUCTIONS FOR THE COMPLETION OF FORM 2PROJECT FUNDING PROFILE

Instructions:

Complete all required data cells. If an actual number is not available, use an estimate. Explain all estimates in a note.

The form is intended to provide funding data at a glance on the estimated budgeted amounts and actual expended amounts of an MCH project.

For each fiscal year, the data in the columns labeled Budgeted on this form are to contain the same figures that appear on the Application Face Sheet (for a non-competing continuation) or the Notice of Award (for a performance report). The lines under the columns labeled Expended are to contain the actual amounts expended for each grant year that has been completed.

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FORM 4PROJECT BUDGET AND EXPENDITURES

By Types of Services

FY _____ FY _____TYPES OF SERVICES Budgeted Expende

dBudgeted Expende

dI. Direct Health Care Services

(Basic Health Services and Health Services for CSHCN.) $ $ $ $

II. Enabling Services(Transportation, Translation, Outreach, Respite Care, HealthEducation, Family Support Services, Purchase of Health Insurance, Case Management, and Coordination with Medicaid,WIC and Education.) $ $ $ $

III. Population-Based Services(Newborn Screening, Lead Screening, Immunization, SuddenInfant Death Syndrome Counseling, Oral Health,Injury Prevention, Nutrition, andOutreach/Public Education.) $ $ $ $

IV. Infrastructure Building Services(Needs Assessment, Evaluation, Planning, Policy Development, Coordination, Quality Assurance, Standards Development, Monitoring, Training, Applied Research, Systems of Care, and Information Systems.) $ $ $ $

V. TOTAL $ $ $ $

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INSTRUCTIONS FOR THE COMPLETION OF FORM 4PROJECT BUDGET AND EXPENDITURES BY TYPES OF SERVICES

Complete all required data cells for all years of the g rant. If an actual number is not available, make an estimate. Please explain all estimates in a note. Administrative dollars should be allocated to the appropriate level(s) of the pyramid on lines I, II, II or IV. If an estimate of administrative funds use is necessary, one method would be to allocate those dollars to Lines I, II, III and IV at the same percentage as program dollars are allocated to Lines I through IV.

Note: Lines I, II and II are for projects providing services. If grant funds are used to build the infrastructure for direct care delivery, enabling or population-based services, these amounts should be reported in Line IV (i.e., building data collection capacity for newborn hearing screening).

Line I Direct Health Care Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.

Direct Health Care Services are those services generally delivered one-on-one between a health professional and a patient in an office, clinic or emergency room which may include primary care physicians, registered dietitians, public health or visiting nurses, nurses certified for obstetric and pediatric primary care, medical social workers, nutritionists, dentists, sub-specialty physicians who serve children with special health care needs, audiologists, occupational therapists, physical therapists, speech and language therapists, specialty registered dietitians. Basic services include what most consider ordinary medical care, inpatient and outpatient medical services, allied health services, drugs, laboratory testing, x-ray services, dental care, and pharmaceutical products and services. State Title V programs support - by directly operating programs or by funding local providers - services such as prenatal care, child health including immunizations and treatment or referrals, school health and family planning. For CSHCN, these services include specialty and sub-specialty care for those with HIV/AIDS, hemophilia, birth defects, chronic illness, and other conditions requiring sophisticated technology, access to highly trained specialists, or an array of services not generally available in most communities.

Line II Enabling Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.

Enabling Services allow or provide for access to and the derivation of benefits from, the array of basic health care services and include such things as transportation, translation services, outreach, respite care, health education, family support services, purchase of health insurance, case management, coordination of with Medicaid, WIC and educations. These services are especially required for the low income, disadvantaged, geographically or culturally isolated, and those with special and complicated health needs. For many of these individuals, the enabling services are essential - for without them access is not possible. Enabling services most commonly provided by agencies for CSHCN include transportation, care coordination, translation

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services, home visiting, and family outreach. Family support activities include parent support groups, family training workshops, advocacy, nutrition and social work.

Line III Population-Based Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.

Population Based Services are preventive interventions and personal health services, developed and available for the entire MCH population of the State rather than for individuals in a one-on-one situation. Disease prevention, health promotion, and statewide outreach are major components. Common among these services are newborn screening, lead screening, immunization, Sudden Infant Death Syndrome counseling, oral health, injury prevention, nutrition and outreach/public education. These services are generally available whether the mother or child receives care in the private or public system, in a rural clinic or an HMO, and whether insured or not.

Line IV Infrastructure Building Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.

Infrastructure Building Services are the base of the MCH pyramid of health services and form its foundation. They are activities directed at improving and maintaining the health status of all women and children by providing support for development and maintenance of comprehensive health services systems and resources including development and maintenance of health services standards/guidelines, training, data and planning systems. Examples include needs assessment, evaluation, planning, policy development, coordination, quality assurance, standards development, monitoring, training, applied research, information systems and systems of care. In the development of systems of care it should be assured that the systems are family centered, community based and culturally competent.

Line V Total – Displays the total amounts for each column, budgeted for each year and expended for each year completed.

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OMB No. 0915-0298Expiration Date: 10/31/2012

FORM 6

MATERNAL & CHILD HEALTH DISCRETIONARY GRANTPROJECT ABSTRACT

FOR FY____

PROJECT:__________________________________________________________________________________

I. PROJECT IDENTIFIER INFORMATION 1. Project Title:2. Project Number:

3. E-mail address:

II. BUDGET1. MCHB Grant Award $_____________

(Line 1, Form 2)2. Unobligated Balance $_____________

(Line 2, Form 2)3. Matching Funds (if applicable) $_____________

(Line 3, Form 2)4. Other Project Funds $_____________

(Line 4, Form 2)5. Total Project Funds $_____________

(Line 5, Form 2)

III. TYPE(S) OF SERVICE PROVIDED (Choose all that apply) [ ] Direct Health Care Services

[ ] Enabling Services[ ] Population-Based Services[ ] Infrastructure Building Services

IV. PROJECT DESCRIPTION OR EXPERIENCE TO DATEA. Project Description

1. Problem (in 50 words, maximum):

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2. Goals and Objectives: (List up to 5 major goals and time-framed objectives per goal for the project)

Goal 1:Objective 1:Objective 2:

Goal 2:Objective 1:Objective 2:

Goal 3:Objective 1:Objective 2:

Goal 4:Objective 1:Objective 2:

Goal 5:Objective 1:Objective 2:

3. Activities planned to meet project goals

4. Specify the primary Healthy People 2010 objectives(s) (up to three) which this project addresses:

a.

b.

c.

5. Coordination (List the State, local health agencies or other organizations involved in the project and their roles)

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6. Evaluation (briefly describe the methods which will be used to determine whether process and outcome objectives are met)

B. Continuing Grants ONLY1. Experience to Date (For continuing projects ONLY):

2. Website URL and annual number of hits

V. KEY WORDS

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VI. ANNOTATION

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INSTRUCTIONS FOR THE COMPLETION OF FORM 6PROJECT ABSTRACT

NOTE: All information provided should fit into the space provided in the form. The completed form should be no more than 3 pages in length. Where information has previously been entered in forms 1 through 5, the information will automatically be transferred electronically to the appropriate place on this form.

Section I – Project Identifier InformationProject Title: Displays the title for the project.Project Number: Displays the number assigned to the project (e.g., the grant

number)E-mail address: Displays the electronic mail address of the project director

Section II – Budget - These figures will be transferred from Form 1, Lines 1 through 5.

Section III - Types of ServicesIndicate which type(s) of services your project provides, checking all that apply.

Section IV – Program Description OR Current Status (DO NOT EXCEED THE SPACE PROVIDED)

A. New Projects only are to complete the following items:1. A brief description of the project and the problem it addresses, such as preventive

and primary care services for pregnant women, mothers, and infants; preventive and primary care services for children; and services for Children with Special Health Care Needs.

2. Provide up to 5 goals of the project, in priority order. Examples are: To reduce the barriers to the delivery of care for pregnant women, to reduce the infant mortality rate for minorities and “services or system development for children with special healthcare needs.” MCHB will capture annually every project’s top goals in an information system for comparison, tracking, and reporting purposes; you must list at least 1 and no more than 5 goals. For each goal, list the two most important objectives. The objective must be specific (i.e., decrease incidence by 10%) and time limited (by 2005).

3. Displays the primary Healthy People 2010 goal(s) that the project addresses.4. Describe the programs and activities used to attain the goals and objectives, and

comment on innovation, cost, and other characteristics of the methodology, proposed or are being implemented. Lists with numbered items can be used in this section.

5. Describe the coordination planned and carried out, in the space provided, if applicable, with appropriate State and/or local health and other agencies in areas(s) served by the project.

6. Briefly describe the evaluation methods that will be used to assess the success of the project in attaining its goals and objectives.

B. For continuing projects ONLY:

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1. Provide a brief description of the major activities and accomplishments over the past year (not to exceed 200 words).

2. Provide website and number of hits annually, if applicable.

Section V – Key Words Provide up to 10 key words to describe the project, including populations served. Choose key words from the included list.

Section VI – AnnotationProvide a three- to five-sentence description of your project that identifies the project’s purpose, the needs and problems, which are addressed, the goals and objectives of the project, the activities, which will be used to attain the goals, and the materials, which will be developed.

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FORM 7DISCRETIONARY GRANT PROJECT

SUMMARY DATA

1. Project Service Focus[ ] Urban/Central City [ ] Suburban [ ] Metropolitan Area (city & suburbs)[ ] Rural [ ] Frontier [ ] Border (US-Mexico)

2. Project Scope[ ] Local [ ] Multi-county [ ] State-wide[ ] Regional [ ] National

3. Grantee Organization Type[ ] State Agency[ ] Community Government Agency[ ] School District[ ] University/Institution Of Higher Learning (Non-Hospital Based)[ ] Academic Medical Center[ ] Community-Based Non-Governmental Organization (Health Care)[ ] Community-Based Non-Governmental Organization (Non-Health Care)[ ] Professional Membership Organization (Individuals Constitute Its

Membership)[ ] National Organization (Other Organizations Constitute Its Membership)[ ] National Organization (Non-Membership Based)[ ] Independent Research/Planning/Policy Organization[ ] Other

_________________________________________________________

4. Project Infrastructure Focus (from MCH Pyramid) if applicable[ ] Guidelines/Standards Development And Maintenance[ ] Policies And Programs Study And Analysis[ ] Synthesis Of Data And Information[ ] Translation Of Data And Information For Different Audiences[ ] Dissemination Of Information And Resources[ ] Quality Assurance[ ] Technical Assistance[ ] Training[ ] Systems Development[ ] Other

5. Demographic Characteristics of Project Participants

Indicate the service level:

Direct Health Care Services Population-Based ServicesEnabling Services Infrastructure Building Services

RACE (Indicate all that apply) ETHNICITY

American Indian

or Alaska Native

Asian

Black or African America

n

Native Hawaiia

n or Other Pacific Islander

White

More

than One Race

Unrecorded

Total

Hispanic or

Latino

Not Hispani

c or Latino

Unrecorded

Total

Pregnant Women (All Ages)Infants <1 yearChildren and Youth 1 to 25 yearsCSHCN Infants <1 yearCSHCN Children and Youth 1 to 25

yearsWomen25+ yearsMen 25+

TOTALS

6. Clients’ Primary Language(s)

______________________________________________________________________________________________________

7. Resource/TA and Training Centers ONLYAnswer all that apply.a. Characteristics of Primary Intended Audience(s)

[ ] Policy Makers/Public Servants[ ] Consumers

[ ] Providers/Professionalsb. Number of Requests Received/Answered: ___/____c. Number of Continuing Education credits provided: _______d. Number of Individuals/Participants Reached: _______e. Number of Organizations Assisted: _______f. Major Type of TA or Training Provided:

[ ] continuing education courses, [ ] workshops, [ ] on-site assistance, [ ] distance learning classes[ ] other

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INSTRUCTIONS FOR THE COMPLETION OF FORM 7PROJECT SUMMARY

Section 1 – Project Service FocusSelect all that apply

Section 2 – Project ScopeChoose the one that best applies to your project.

Section 3 – Grantee Organization TypeChoose the one that best applies to your organization.

Section 4 – Project Infrastructure FocusIf applicable, choose all that apply.

Section 5 – Demographic Characteristics of Project ParticipantsIndicate the service level for the grant program. Multiple selections may be made. Infrastructure cannot be selected by itself; it must be selected with another service level. Please fill in each of the cells as appropriate.

Direct Health Care Services are those services generally delivered one-on-one between a health professional and a patient in an office, clinic or emergency room which may include primary care physicians, registered dietitians, public health or visiting nurses, nurses certified for obstetric and pediatric primary care, medical social workers, nutritionists, dentists, sub-specialty physicians who serve children with special health care needs, audiologists, occupational therapists, physical therapists, speech and language therapists, specialty registered dietitians. Basic services include what most consider ordinary medical care, inpatient and outpatient medical services, allied health services, drugs, laboratory testing, x-ray services, dental care, and pharmaceutical products and services. State Title V programs support - by directly operating programs or by funding local providers - services such as prenatal care, child health including immunizations and treatment or referrals, school health and family planning. For CSHCN, these services include specialty and sub-specialty care for those with HIV/AIDS, hemophilia, birth defects, chronic illness, and other conditions requiring sophisticated technology, access to highly trained specialists, or an array of services not generally available in most communities.

Enabling Services allow or provide for access to and the derivation of benefits from, the array of basic health care services and include such things as transportation, translation services, outreach, respite care, health education, family support services, purchase of health insurance, case management, coordination of with Medicaid, WIC and educations. These services are especially required for the low income, disadvantaged, geographically or culturally isolated, and those with special and complicated health needs. For many of these individuals, the enabling services are essential - for without them access is not possible. Enabling services most commonly provided by agencies for CSHCN include transportation, care coordination, translation services, home visiting, and family outreach. Family support activities include parent support groups, family training workshops, advocacy, nutrition and social work.

Population Based Services are preventive interventions and personal health services, developed and available for the entire MCH population of the State rather than for individuals in a one-on-

HRSA-11-079 60

one situation. Disease prevention, health promotion, and statewide outreach are major components. Common among these services are newborn screening, lead screening, immunization, Sudden Infant Death Syndrome counseling, oral health, injury prevention, nutrition and outreach/public education. These services are generally available whether the mother or child receives care in the private or public system, in a rural clinic or an HMO, and whether insured or not.

Infrastructure Building Services are the base of the MCH pyramid of health services and form its foundation. They are activities directed at improving and maintaining the health status of all women and children by providing support for development and maintenance of comprehensive health services systems and resources including development and maintenance of health services standards/guidelines, training, data and planning systems. Examples include needs assessment, evaluation, planning, policy development, coordination, quality assurance, standards development, monitoring, training, applied research, information systems and systems of care. In the development of systems of care it should be assured that the systems are family centered, community based and culturally competent.

Section 6 – Clients Primary Language(s) Indicate which languages your clients speak as their primary language, other than English, for the data provided in Section 6. List up to three languages.

Section 7 – Resource/TA and Training Centers (Only)Answer all that apply.

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03 PERFORMANCE MEASURE

Goal 1: Provide National Leadership for MCHB(Strengthen the MCH knowledge base and support scholarship within the MCH community)Level: GranteeCategory: Information Dissemination

The percentage of MCHB-funded projects submitting and publishing findings in peer-reviewed journals.

GOAL To increase the number of MCHB-funded research projects that publish in peer-reviewed journals.

MEASURE The percent of MCHB-funded projects submitting articles and publishing findings in peer-reviewed journals.

DEFINITION Numerator: Number of projects (current and completed within the past three years) that have submitted articles for review by refereed journals.

Denominator: Total number of current projects and projects that have been completed within the past three years.

And

Numerator: Number of projects (current and completed within the past 3 years) that have published articles in peer reviewed journals

Denominator: Total number of current projects and projects that have been completed within the past three years.Units: 100 Text: Percent.

HEALTHY PEOPLE 2010 OBJECTIVE Related to Goal 1: Improve access to comprehensive, high-quality health care services (Objectives 1.1- 1.16).

DATA SOURCE(S) AND ISSUES Attached data collection form will be sent annually to grantees during their funding period and three years after the funding

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period ends.Some preliminary information may be gathered from mandated project final reports

SIGNIFICANCE To be useful, the latest evidence-based, scientific knowledge must reach professionals who are delivering services, developing programs and making policy. Peer reviewed journals are considered one of the best methods for distributing new knowledge because of their wide circulation and rigorous standard of review.

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DATA COLLECTION FORM FOR DETAIL SHEET #03

Please use the space provided for notes to detail the data source and year of data used.

Number of articles submitted for review by refereed journals but not yet published in this reporting year

Number of articles published in peer-reviewed journals this reporting year

NOTES/COMMENTS:

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10 PERFORMANCE MEASURE

Goal 2: Eliminate Health Barriers & Disparities(Develop and promote health services and systems of care designed to eliminate disparities and barriers across MCH populations)Level: GranteeCategory: Cultural Competence

The degree to which MCHB-funded programs have incorporated cultural and linguistic competence elements into their policies, guidelines, contracts and training.

GOAL To increase the number of MCHB-funded programs that have integrated cultural and linguistic competence into their policies, guidelines, contracts and training.

MEASURE The degree to which MCHB-funded programs have incorporated cultural and linguistic competence elements into their policies, guidelines, contracts and training.

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DEFINITION Attached is a checklist of 15 elements that demonstrate cultural and linguistic competency. Please check the degree to which the elements have been implemented. The answer scale for the entire measure is 0-45. Please keep the completed checklist attached.

Cultural and linguistic competence is a set of congruent behaviors, attitudes, and policies that come together in a system, agency, or among professionals that enables effective work in cross-cultural situations. ‘Culture’ refers to integrated patterns of human behavior that include the language, thoughts, communications, actions, customs, beliefs, values, and institutions of racial, ethnic, religious, or social groups. ‘Competence’ implies having the capacity to function effectively as an individual and an organization within the context of the cultural beliefs, behaviors, and needs presented by consumers and their communities. (Adapted from Cross, 1989; sited from DHHS Office of Minority Health-- http://www.omhrc.gov/templates/browse.aspx?lvl=2&lvlid=11)

Linguistic competence is the capacity of an organization and its personnel to communicate effectively, and convey information in a manner that is easily understood by diverse audiences including persons of limited English proficiency, those who have low literacy skills or are not literate, and individuals with disabilities. Linguistic competency requires organizational and provider capacity to respond effectively to the health literacy needs of populations served. The organization must have policy, structures, practices, procedures, and dedicated resources to support this capacity. (Goode, T. and W. Jones, 2004. National Center for Cultural Competence; http://www.nccccurricula.info/linguisticcompetence.html)

Cultural and linguistic competency is a

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process that occurs along a developmental continuum. A culturally and linguistically competent program is characterized by elements including the following: written strategies for advancing cultural competence; cultural and linguistic competency policies and practices; cultural and linguistic competence knowledge and skills building efforts; research data on populations served according to racial, ethnic, and linguistic groupings; participation of community and family members of diverse cultures in all aspects of the program; faculty and other instructors are racially and ethnically diverse; faculty and staff participate in professional development activities related to cultural and linguistic competence; and periodic assessment of trainees’ progress in developing cultural and linguistic competence.

HEALTHY PEOPLE 2010 OBJECTIVE Related to the following HP2010 Objectives:

16.23: Increase the proportion of States and jurisdictions that have service systems for children with or at risk for chronic and disabling conditions as required by Public Law 101-239.

23.9: (Developmental) Increase the proportion of schools for public health workers that integrate into their curricula specific content to develop competency in the essential public health services.

23.11:(Developmental) Increase the proportion of State and local public health agencies that meet national performance standards for essential public health services.

23.15: (Developmental) Increase the proportion of Federal, Tribal, State, and local jurisdictions that review and evaluate the extent to which their statutes, ordinances, and bylaws assure the delivery of essential public health services.

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DATA SOURCE(S) AND ISSUES Attached data collection form is to be completed by grantees.There is no existing national data source to measure the extent to which MCHB supported programs have incorporated cultural competence elements into their policies, guidelines, contracts and training.

SIGNIFICANCE Over the last decade, researchers and policymakers have emphasized the central influence of cultural values and cultural/linguistic barriers: health seeking behavior, access to care, and racial and ethnic disparities. In accordance with these concerns, cultural competence objectives have been: (1) incorporated into the MCHB strategic plan; and (2) in guidance materials related to the Omnibus Budget Reconciliation Act of 1989 (OBRA ’89), which is the legislative mandate that health programs supported by MCHB Children with Special Health Care Needs (CSHCN) provide and promote family centered, community-based, coordinated care.

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DATA COLLECTION FORM FOR DETAIL SHEET #10

Using a scale of 0-3, please rate the degree to which your grant program has incorporated the following cultural/linguistic competence elements into your policies, guidelines, contracts and training.

Please use the space provided for notes to describe activities related to each element, detail data sources and year of data used to develop score, clarify any reasons for score, and or explain the applicability of elements to program.

0 1 2 3 Element1. Strategies for advancing cultural and linguistic competency are

integrated into your program’s written plan(s) (e.g., grant application, recruiting plan, placement procedures, monitoring and evaluation plan, human resources, formal agreements, etc.).

2. There are structures, resources, and practices within your program to advance and sustain cultural and linguistic competency.

3. Cultural and linguistic competence knowledge and skills building are included in training aspects of your program.

4. Research or program information gathering includes the collection and analysis of data on populations served according to racial, ethnic, and linguistic groupings, where appropriate.

5. Community and family members from diverse cultural groups are partners in planning your program.

6. Community and family members from diverse cultural groups are partners in the delivery of your program.

7. Community and family members from diverse cultural groups are partners in evaluation of your program.

8. Staff and faculty reflect cultural and linguistic diversity of the significant populations served.

9. Staff and faculty participate in professional development activities to promote their cultural and linguistic competence.

10. A process is in place to assess the progress of your program participants in developing cultural and linguistic competence.

0 = Not Met1 = Partially Met2 = Mostly Met3 = Completely Met

Total the numbers in the boxes (possible 0-30 score) __________

NOTES/COMMENTS:

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24 PERFORMANCE MEASURE

Goal 4: Improve the Health Infrastructure and Systems of Care(Assist States and communities to plan and develop comprehensive, integrated health service systems)Level: State, Community, or GranteeCategory: Infrastructure

The degree to which MCHB-funded initiatives contribute to infrastructure development through core public health assessment, policy development and assurance functions.

GOAL To develop infrastructure that supports comprehensive and integrated services.

MEASURE The degree to which MCHB-supported initiatives contribute to the implementation of the 10 MCH Essential Services and Core Public Health Program Functions of assessment, policy development and assurance.

DEFINITION Attached is a checklist of 10 elements that comprise infrastructure development services for maternal and child health populations. Please score the degree to which each your program contributes to the implementation of each of these elements Each element should be scored 0-2, with a maximum total score of 20 across all elements.

HEALTHY PEOPLE 2010 OBJECTIVE

Related to Healthy People Goal 23, Objective 12 (23.12): Increase the proportion of tribes, States, and local health agencies that have implemented a health improvement plan and increase the proportion of local health jurisdictions that have a health improvement plan linked with their State plan.

DATA SOURCE(S) AND ISSUES Attached data collection form to be completed by grantees based on activities they are directly engaged in or that they contribute to the implementation of by other MCH grantees or programs.

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SIGNIFICANCE Improving the health infrastructure and systems of care is one of the five goals of MCHB. There are five strategies under this goal, all of which are addressed in a number of MCHB initiatives which focus on system-building and infrastructure development. These five strategies follow:

Build analytic capacity for assessment, planning, and evaluation. Using the best available evidence, develop and promote guidelines and practices that improve services and systems of care. Assist States and communities to plan and develop comprehensive, integrated health service systems. Work with States and communities to assure that services and systems of care reach targeted populations. Work with States and communities to address selected issues within targeted populations.

The ten elements in this measure are comparable to the 10 Essential Public Health Services outlined in Grason H, Guyer B, 1995. Public MCH Program Functions Framework: Essential Public Health Services to Promote Maternal and Child Health in America. Baltimore, MD: The Women’s and Children’s Health Policy Center, The Johns Hopkins University.

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DATA COLLECTION FORM FOR DETAIL SHEET #24

Use the scale below to describe the extent to which your program or initiative has contributed to the implementation of each of the following Public MCH Program core function activities at the local, State, or national level. Please use the space provided for notes to clarify reasons for score.

0 1 2 Element

Assessment Function Activities

1. Assessment and monitoring of maternal and child health status to indentify and address problems, including a focus on addressing health disparities [Examples of activities include: developing frameworks, methodologies, and tools for standardized MCH data in public and private sectors; implementing population-specific accountability for MCH components of data systems, and analysis, preparation and reporting on trends of MCH data and health disparities among subgroups.]

2. Diagnosis and investigation health problems and health hazards affecting maternal and child health populations[Examples of activities include conduct of population surveys and reports on risk conditions and behaviors, identification of environmental hazards and preparation of reports on risk conditions and behaviors.]

3. Informing and educating the public and families about MCH issues.

Policy Development Function Activities

4. Mobilization of community collaborations and partnerships to identify and solve MCH problems. [Examples of stakeholders to be involved in these partnerships include: policymakers, health care providers, health care insurers and purchasers, families, and other MCH care consumers.]

5. Provision of leadership for priority setting, planning and policy development to support community efforts to assure the health of maternal and child health populations.

6. Promotion and enforcement of legal requirements that protect the health and safety of maternal and child health populations.

Assurance Function Activities

7. Linkage of maternal and child health populations to health and other community and family services, and assuring access to comprehensive quality systems of care

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8. Assuring the capacity and competency of the public health and personal health workforce to effectively and efficiently address MCH needs.

9. Evaluate the effectiveness, accessibility and quality of direct, enabling and population-based preventive MCH services

\ 10. Research and demonstrations to gain new insights and innovative solutions to MCH-related issues and problems

0 = Grantee does not provide or contribute to the provision of this activity.1 = Grantee sometimes provides or contributes to the provision of this activity.2 = Grantee regularly provides or contributes to the provision of this activityTotal the numbers in the boxes (possible 0–20 score): _________

NOTES/COMMENTS:

27 PERFORMANCE MEASURE

Goal 4: Improve the Health Infrastructure and Systems of Care by Improving MCH Knowledge and Available ResourcesLevel: GranteeCategory: Infrastructure

The degree to which grantees have mechanisms in place to ensure quality in the design, development, and dissemination of new information resources that they produce each year.

GOAL To improve the dissemination of new knowledge to the MCH field by increasing the quality of informational resources produced, including articles, chapters, books, and other materials produced by grantees, and by addressing the quality in design and development. This includes consumer education materials, conference presentations, and electronically available materials.

MEASURE The degree to which grantees have mechanisms in place to ensure quality in the design, development, and dissemination of new informational resources they produce each year.

DEFINITION Publications are articles, books, or chapters published during the year being reported. Products include electronic Web-based resources, video training tapes, CD ROMs, DVD, materials created for consumers (parents, children, and community agencies). Products and publications also include outreach and

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marketing materials (such as presentations, alerts, and HRSA clearinghouse materials).

Details on these publications and products are reported on a data collection form. These products are summed by category and the total number of all publications and products are reported on a PM tracking form for a reporting year.

This measure can be applicable to any MCHB grantee.

HEALTHY PEOPLE 2010 OBJECTIVE

Related to Goal 1: Improve access to comprehensive, high-quality health care services. Specific objective: 1.3.Related to Goal 7 – Educational and community-based programs: Increase the quality, availability and effectiveness of educational and community-based programs designed to prevent disease and improve health and quality of life. Specific objectives: 7.7 through 7.12.Related Goal 11 – Use communication strategically to improve health. Specific objective: 11.3.Related to Goal 23 – Public Health Infrastructure: Ensure that Federal, tribal, State, and local health agencies have the infrastructure to provide essential public health services effectively. Specific objective: 23.2.

DATA SOURCE(S) AND ISSUES Data will be collected by grantees throughout the year and reported in their annual reports and via this measure’s data collection form.

SIGNIFICANCE Advancing the field of MCH based on evidence-based, field-tested quality products. Collection of the types of and dissemination of MCH products and publications is crucial for advancing the field. This PM addresses the production and quality of new informational resources created by grantees for families, professionals, other providers, and the public.

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DATA COLLECTION FORM FOR DETAIL SHEET #27

Using the 0–3 scale below indicate the degree to which your grant has incorporated each of the design, dissemination, and continuous quality improvement activities into MCH information resources that you have developed within the past year. Please use the space provided for notes to describe activities related to each element and clarify any reasons for the score

0 1 2 3 Element

Mechanisms in Place to Ensure Quality in Design of Informational Resources

1. Obtain input from the target audience or other experts to ensure relevance. The grantee conducts activities to ensure the information resource is relevant to the target audience with respect to knowledge, issues, and best practices in the MCH field.[Example: Obtain target audience, user, or expert input in the design of informational resources, the testing or piloting of products with the potential users/audience, and the use of expert reviews of new products.]

2. Obtain input from the target audience or other experts to ensure cultural and linguistic appropriateness. The grantee specifically employs mechanisms to ensure that resources are culturally and linguistically appropriate to meet the needs and level of the target audience(s).

3. Build on Existing Information Resources and Expertise, and Ensure Up-to-Date Content. As part of the development of information resources, the grantee conducts activities (such as reviewing existing bibliographies, information resources, or other materials) to ensure that the information provided in newly developed information resources is up to date with standard practice; based on research-, evidence-, and best practice-based literature or materials in the MCH field; and is aligned with local, State, and/or Federal initiatives. Grantee uses these mechanisms to ensure that information resource content does not duplicate existing resources available to the same audience. Also include in the design and development expert review panels (experts may include target audience members).

Mechanisms in Place to Track Dissemination and Use of Resources or Products

4. The grantee has a system to track, monitor, and analyze the dissemination and reach of products. The grantee implements a mechanism for tracking and documenting dissemination of products, and uses this information to ensure the target audience(s) is reached. Grantees with a Web site should include mechanisms for tracking newly created resources disseminated through their Web sites and

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0 1 2 3 Element

are encouraged to detail Web-related dissemination mechanisms and the use of Web-based products in the Notes section below. Grantee ensures that format is accessible to diverse audiences and conforms to ADA guidelines and to Section 508 of the Rehabilitation Act.

5. The grantee has a system in place to track, monitor, and analyze the use of products. The grantee routinely collects data from the recipients of its products and resources to assess their satisfaction with products, and whether products are useful, share new and relevant information, and enhance MCH knowledge. [An example of data collection is assessments.]

Mechanisms in Place to Promote Grantee’s Information Resources

6. Conduct Culturally Appropriate Outreach and Promotion to Ensure Target Audience is Aware of Information Resources The grantee routinely uses mechanisms to reach out to MCHB grantees and other target audiences such as provider or family organizations, consumers of MCH services, and the public, to make sure that target audiences know the resources are available. [Examples of outreach methods include promotion of services through list servs, exhibits at meetings, and targeted outreach to representatives of individual organizations or MCHB grantees.]

Use of Evaluation Data for Quality Improvement

7. Use of Feedback for Quality Improvement. The degree to which the grantee has used the results of satisfaction and other feedback mechanisms to improve the content, reach, and effectiveness of their products/information resources.

0=Not Met1=Partially Met2=Mostly Met3=Completely Met

Total the numbers in the boxes (possible 0–21 score): __________

NOTES/COMMENTS:

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33 PERFORMANCE MEASURE

Goal 4: Improve the Health Infrastructure and Systems of Care (Assist States and communities to plan and develop comprehensive, integrated health service systems)Level: GranteeCategory: Infrastructure

The degree to which MCHB-funded initiatives work to promote sustainability of their programs or initiatives beyond the life of MCHB funding.

GOAL To develop infrastructure that supports comprehensive and integrated systems of care for maternal and child health at the local and/or state level.

MEASURE The degree to which MCHB grantees are planning and implementing strategies to sustain their programs once initial MCHB funding ends.

DEFINITION Attached is a checklist of nine actions or strategies that build toward program sustainability. Please check the degree to which each of the elements is being planned or carried out by your program, using the three-point scale. The maximum total score for this measure would be 45 across all elements.

HEALTHY PEOPLE 2010 OBJECTIVE

Related to Healthy People Goal 23, Objective 12 (23.12): Increase the proportion of Tribes, States, and local health agencies that have implemented a health improvement plan and increase the proportion of local health jurisdictions that have a health improvement plan linked with their State plan.

DATA SOURCE(S) AND ISSUES Attached is a data collection form to be completed by grantees. Since these actions and their outcomes are necessarily progressive over time from the beginning to the end of a program funding period, grantees’ ratings on each element are

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expected to begin lower in the first year of grant award and increase over time.

SIGNIFICANCE In recognition of the increasing call for recipients of public funds to sustain their programs after initial funding ends, MCHB encourages grantees to work toward sustainability throughout their grant periods. A number of different terms and explanations have been used as operational components of sustainability. These components fall into four major categories, each emphasizing a distinct focal point as being at the heart of the sustainability process: (1) adherence to program principles and objectives, (2) organizational integration, (3) maintenance of health benefits, and (4) State or community capacity building. Specific recommended actions that can help grantees build toward each of these four sustainability components are included as the data elements for this PM.

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DATA COLLECTION FORM FOR DETAIL SHEET #33

Use the scale below to rate the degree to which your program has taken the following actions to promote sustainability of your program or initiative. Since these actions and their outcomes are necessarily progressive over the funding period, the ratings are expected to begin lower and progress over the grant period.

Please use the space provided for notes to clarify reasons for score.

0 1 2 3 Element

1. A written sustainability plan is in place within two years of the MCHB grant award, with goals, objectives, action steps, and timelines to monitor plan progress.

2. Staff and leaders in the organization engage and build partnerships with consumers, and other key stakeholders in the community, in the early project planning, and in sustainability planning and implementation processes.

3. There is support for the MCHB-funded program or initiative within the parent agency or organization, including from individuals with planning and decision making authority.

4. There is an advisory group or a formal board that includes family, community and state partners, and other stakeholders who can leverage resources or otherwise help to sustain the successful aspects of the program or initiative.

5. The program’s successes and identification of needs are communicated within and outside the organization among partners and the public, using various internal communication, outreach and marketing strategies.

6. The grantee identified, actively sought, and obtained other funding sources and in-kind resources to sustain the program or initiative.

7. Policies and procedures developed for the successful aspects of the program or initiative are incorporated into the parent or another organization’s system of programs and services.

8. The responsibilities for carrying out key successful aspects of the program or initiative have begun to be transferred to permanent staff positions in other ongoing programs or organizations.

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9. The grantee has secured financial or in-kind support from within the parent organization or external organizations to sustain the successful aspects of the MCHB-funded program or initiative.

0 = Not Met1 = Partially Met2 = Mostly Met3 = Completely MetTotal the numbers in the boxes (possible 0–27 score): _________

NOTES/COMMENTS:

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Products, Publications and Submissions Data Collection Form

Part 1

Instructions: Please list the number of products, publications and submissions addressing maternal and child health that have been published or produced by your staff during the reporting period (counting the original completed product or publication developed, not each time it is disseminated or presented). Products and Publications include the following types:

Type Number

Peer-reviewed publications in scholarly journals – published (including peer-reviewed journal commentaries or supplements)

Peer-reviewed publications in scholarly journals – submitted

Books

Book chapters

Reports and monographs (including policy briefs and best practices reports)

Conference presentations and posters presented

Web-based products (Blogs, podcasts, Web-based video clips, wikis, RSS feeds, news aggregators, social networking sites)

Electronic products (CD-ROMs, DVDs, audio or videotapes)

Press communications (TV/Radio interviews, newspaper interviews, public service announcements, and editorial articles)

Newsletters (electronic or print)

Pamphlets, brochures, or fact sheets

Academic course development

Distance learning modules

Doctoral dissertations/Master’s theses

Other

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Part 2Instructions: For each product, publication and submission listed in Part 1, complete all elements marked with an “*.”

Data collection form: Peer-reviewed publications in scholarly journals – published*Title: ________________________________________________________________________

*Author(s): ____________________________________________________________________

*Publication: __________________________________________________________________

*Volume: ______ *Number: _______ Supplement: _____ *Year: _______ *Page(s):________

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL): ________________________________________________________

Key Words (No more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Peer-reviewed publications in scholarly journals – submitted*Title: ________________________________________________________________________

*Author(s): ____________________________________________________________________

*Publication: __________________________________________________________________

*Year Submitted: _______

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

Key Words (No more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Books*Title: ________________________________________________________________________

*Author(s): ____________________________________________________________________

*Publisher: ____________________________________________________________________

*Year Published: _______

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

Key Words (No more than 5): _____________________________________________________

Notes: ________________________________________________________________________

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Data collection form for: Book chaptersNote: If multiple chapters are developed for the same book, list them separately.

*Chapter Title: ________________________________________________________________

*Chapter Author(s): _____________________________________________________________

*Book Title: __________________________________________________________________

*Book Author(s): ______________________________________________________________

*Publisher: ___________________________________________________________________

*Year Published: ______

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

Key Words (no more than 5): _____________________________________________________

Notes: _______________________________________________________________________

Data collection form: Reports and monographs*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year Published: _________

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: _______________________________________________________________________

Data collection form: Conference presentations and posters presented(This section is not required for MCHB Training grantees.)

*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Meeting/Conference Name: ______________________________________________________

*Year Presented: _________

*Type: Presentation Poster

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

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Notes: ________________________________________________________________________

Data collection form: Web-based products*Product: _____________________________________________________________________

*Year: _________

*Type: blogs podcasts Web-based video clips

wikis RSS feeds news aggregators

social networking sites Other (Specify)

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL): ________________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Electronic Products*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Type: CD-ROMs DVDs audio tapes

videotapes Other (Specify)

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Press Communications*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Type: TV interview Radio interview Newspaper interview

Public service announcement

Editorial article Other (Specify)

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

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*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Newsletters*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Type: Electronic Print Both

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

*Frequency of distribution: weekly monthly quarterly annually Other (Specify)

Number of subscribers: __________________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Pamphlets, brochures or fact sheets*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Type: Pamphlet Brochure Fact Sheet

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Academic course development*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

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Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Distance learning modules*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

*Media Type: blogs podcasts Web-based video clips

wikis RSS feeds news aggregators

social networking sites

CD-ROMs DVDs

audio tapes videotapes Other (Specify)

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Data collection form: Doctoral dissertations/Master’s theses*Title: ________________________________________________________________________

*Author: ______________________________________________________________________

*Year Completed: _________

*Type: Doctoral dissertation Master’s thesis

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

Other (Note, up to 3 may be entered)

*Title: ________________________________________________________________________

*Author(s)/Organization(s): _______________________________________________________

*Year: _________

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*Describe product, publication or submission: ________________________________________

_____________________________________________________________________________

*Target Audience: Consumers/Families ___ Professionals ___ Policymakers ___ Students ____

*To obtain copies (URL or email): _________________________________________________

Key Words (no more than 5): _____________________________________________________

Notes: ________________________________________________________________________

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Appendix B

Pediatric Emergency Care Applied Research Network (PECARN)

DRAFT POLICIES AND PROCEDURES

Table of Contents

1. Bylaws 2. Policy and Procedures 3. Development and Approval of Research Concepts and Protocols 4. Finalization and Amendment of PECARN Protocols 5. Feasibility and Budget Review 6. Institutional Review Board Approval 7. Informed Consent Process 8. Adverse Event Recognition and Reporting 9. Site Monitoring in PECARN Research Studies 10. Archiving Study Records 11. Financial Conflict of Interest 12. Information Systems and Data Management Access Control 13. Data Management, Documentation, and Retention 14. Creating a Public Use Data Set 15. Personnel Training

Note: This appendix contains selected, relevant bylaws, policies and procedures necessary to apply for this funding opportunity announcement. The full policies and are considered DRAFT.

For further information please contact Dr Tasmeen Weik at tweiktweak@hrsa.gov

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BYLAWS

I. Name: PECARN

II. Purpose1. Mission Statement

The Pediatric Emergency Care Applied Research Network (PECARN) is dedicated to improving the health care for ill and injured children.  PECARN will perform meaningful and rigorous multi-institutional research into the prevention and management of acute illnesses and injuries in children in order to promote their health in all phases of care.  PECARN will also provide the leadership and infrastructure needed to support research collaboration among EMSC investigators and informational exchanges between EMSC investigators, providers, and the communities they serve in order to significantly improve EMSC care delivery.

2. Research Agenda

The research agenda of PECARN is focused on achieving the goals of the mission statement. In general, the research agenda follows that of pre-existing consensus-derived EMSC research agenda as well as the written PECARN research priorities established by consensus within the PECARN.

III. Structure

PECARN Steering Committee and SubcommitteesResearch NodesResearch Node Centers (RNC)Hospital Emergency Department Affiliates (HEDA)Central Data Management and Coordinating Center (CDMCC)Working Groups

IV. PECARN Membership

1. Steering Committee Membership

Categories of PECARN membership include Voting and Participating members.

a. Voting members include:i. Principal investigators of the Research Node Center (RNC)

ii. Principal investigator of the Central Data Management Coordinating Center (CDMCC)

iii. HEDA Principal Investigators. Note: if an RNC has both a nodal principal investigator and a HEDA principal investigator, the vote belongs to the RNC principal investigator. Each HEDA has 1 vote.

b. Participating members include other invited participants such as nodal administrators, the CDMCC project manager and other subcommittee members.

2. Executive Committee Membership

Executive committee membership will include the following voting members: i. Principal investigators of the Research Node Center (RNC)

ii. Principal investigator of the Central Data Management Coordinating Center (CDMCC)

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Nodal administrators and the CDMCC project managers may participate in executive committee as needed.

3. Subcommittee Membership

Both voting and participating members of PECARN may serve as members of the PECARN Subcommittees.

The Subcommittees will consist of two representatives from each Research Node, selected by the Research Node PI. Each subcommittee will vote to add additional members if deemed essential for functioning of the committee, and make additional appointments, subject to approval of the Steering Committee. All subcommittee members have voting privileges within the subcommittee. Subcommittee Chairs are appointed by the Executive committee for a term of 2 years.

Role of External Investigators in Committees

In certain circumstances, external investigators who are not otherwise members of PECARN may be invited to participate as associate members of specific committees. This may occur when the Chair of that committee deems it necessary because special expertise is lacking in the committee. This invitation must be approved by vote of the Executive Committee. External investigators may be invited by a Research Node, a Subcommittee, a Working Group, or by the Steering Committee. Any sponsor of an external investigator assumes responsibility for the investigator within PECARN. No external investigators will be voting members of PECARN.

V. Officers of PECARN

1. Steering Committee and Subcommittee Officers

Steering Committee Officers

Officers of PECARN Steering Committee will include the Chair, Vice-Chair, and Secretary. Duties of the PECARN Steering Committee officers:

a. Duties of the PECARN Chair are primarily those of overseeing the operation of PECARN, which includes coordinating and running the Steering Committee meetings, appointing Subcommittee Chairpersons to be later approved by the Steering Committee, maintaining ongoing communications with nodal PIs and keeping all of PECARN updated with new/ongoing activities, and serving as liaison to HRSA/MCHB federal officials.

b. Duties of the Vice-Chair include assisting the Chair with PECARN responsibilities, as deemed necessary. In addition, the Vice-Chair will assume the position of Acting Chair in the event the Chair becomes incapacitated, and will initiate an immediate vote by the Steering Committee to select a new Chair from the RNC PIs. The Vice-Chair may officiate at meetings in the temporary absence of the Chair.

c. The PECARN Secretary will work closely with HRSA/MCHB representatives to insure that careful and authentic records of Steering Committee proceedings are kept. These duties will include carefully reviewing Steering Committee minutes and summaries prepared by the HRSA/MCHB for their accuracy and integrity. The Secretary will also maintain an updated list of all committee officers and members and insure that a copy of the PECARN bylaws is available at all Steering Committee meetings. The PECARN

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Secretary will serve as the primary point of contact for the meeting logistics contractor, coordinating meeting hotels, venues, meeting equipment, etc. In addition, the Secretary will provide administrative support to the Chair of the Protocol Review and Development Subcommittee (PRADS). The Secretary will assume additional responsibilities as deemed appropriate by the Steering Committee Chair and Vice-Chair.

Subcommittee Officers

Each Subcommittee will be led by a Chairperson:

a. The duties of these Chairs will be to oversee the operation of their subcommittees, which includes planning and coordinating the subcommittee meetings, maintaining ongoing communications with subcommittee members as well as serving as liaison to the PECARN Steering Committee. The Chairs will coordinate the generation and review of documents pertinent to their subcommittees, for ultimate approval by the Executive Committee. Subcommittee Chairs will maintain regular communications with the Steering Committee Chair.

2. Terms of Office, Qualifications, and Elections

Terms of Office

a. Steering Committee officers will be elected by the voting members of PECARN. Elected officers will serve two year terms. Any member of PECARN, as defined above, may nominate individuals for an officer position.

Qualifications

a. The Steering Committee Chair and Vice-Chair must be an RNC or CDMCC PIs. The Secretary position must be a PECARN Nodal Administrator or CDMCC project manager.

b. The Subcommittee Chair should typically be, but is not required to be, a voting member of the Steering Committee. If the Subcommittee Chair is not a member of the Steering Committee, s/he will nonetheless be expected to attend Steering Committee meetings.

Elections

a. Elections will be conducted by ballot vote either in person or on the NDDP voting eRoom. Steering Committee officers will be elected by majority vote.

b. Subcommittee Chairs are appointed by the PECARN Chair and are subject to approval by a Steering Committee (majority) vote.

c. PECARN officers can be removed from office by a vote of two-thirds of the PECARN Steering Committee.

d. Nominations can be made by any active member of the PECARN.

e. Removal of an officer before expiration of his or her term requires a 2/3 majority vote.

VI. Meetings

1. Frequency of meetings

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Steering Committee

a. Steering Committee meetings will be held up to two times annually, per HRSA/MCHB funding opportunity announcement. There will also be provisions for electronic and telephonic meetings, as necessary.

Subcommittees

a. Subcommittee meetings will be held in conjunction with steering committee meetings. The subcommittees will also be expected to communicate more frequently via conference call or other electronic means.

2. Alternates

Alternates for Steering Committee and subcommittee members who cannot attend a specified Steering Committee or subcommittee meeting must be designated by the Research Node PI. It is assumed that the alternate should have substantial knowledge of the PECARN issues to be discussed at the specified meeting.

3. Voting

Decisions are made by majority vote of those votes cast, one vote per member or Alternate.

4. Quorum

Steering Committee

a. Steering Committee quorum consists of at least two thirds of RNC PIs plus at least one half of voting HEDA PIs or alternates.

5. Robert’s Rules of Order, Meeting Confidentiality, and Open Meetings

a. Robert’s Rules of Order will be used to conduct the business at PECARN Steering Committee and subcommittee meetings.All members of PECARN and meeting attendees must abide by the confidentiality of research proposal materials presented at PECARN meetings and in PECARN communications. Research proposal review materials and meeting discussions are privileged communications prepared for use only by PECARN members and research program staff. Guest meeting attendees will be informed of the strict confidentiality issues in PECARN and must agree to them prior to attendance.

b. PECARN Steering Committee meetings are open to all active members of PECARN, unless the Steering Committee decides by majority vote to keep a meeting closed. Due to the sensitive nature or confidentiality requirements of the deliberations on some topics and issues, the meetings of the Steering Committee may be closed to all except voting Steering Committee members and members of the federal government participating in PECARN.

c. PECARN subcommittee meetings are open only to subcommittee members, alternates, consultants, Federal Liaisons, all RNC PIs and other PECARN members approved by the Subcommittee Chair, due to the privileged nature of their communications.

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VII. Committees

1. Standing Committees

There are six Standing Committees. The PECARN Steering Committee, Executive Committee and four subcommittees, including the Protocol Concept Review and Development, Safety and Regulatory and Quality Assurance, Feasibility and Budget, and Grant Writing and Publications Subcommittees.

2. Duties

The descriptions and duties of the Steering Committee and Subcommittees are delineated in Policies and Procedures manual.

3. Ad hoc committees

The Steering Committee and Subcommittees may establish ad hoc committees as necessary to carry out the work of the network.

VIII. Policies and Procedures

The PECARN Policies and Procedures manual is a separate document from the PECARN Bylaws, as delineated per HRSA/MCHB guidelines. The Policies and Procedures manual contains the descriptions and duties of the PECARN Steering Committee and subcommittees, as delineated per HRSA/MCHB guidelines, PECARN subcommittee recommendations, and Steering Committee approval.

IX. Code of Ethics

All PECARN members, will be held to the highest ethical principles and standards consistent with the Federal Regulation for Protection of Human Subjects (HRSA Circular No. 96.05, Code of Federal Regulations Title 45 Part 46 (45 CFR Part 46), and the Belmont Report). This includes, but is not limited to, compliance with any and all federal, state or institutional regulations regarding the performance of research.

X. Conflicts of Interest

All PECARN members, are subject to the conflicts of interest policies of their respective educational institutions' policies and applicable federal laws and regulations (per 42 CFR Ch. 1, Subpart F, 50.6), state laws and regulations, and local institutional policies. Potential conflicts of interest are situations which might not allow for impartial or objective determinations. These situations include, but are not limited to, relationships with products, devices, government or companies such as pharmaceutical, formula, or equipment manufacturers. This would also include the receipt of research support or lecture honoraria from such companies or organizations.

In addition to the mandated requirements listed above, PECARN members having any real, perceived or potential conflicts of interest in the development and testing of any drug, technique, methodology or technology are also required to disclose these conflicts to the PECARN Steering Committee at the time the conflict is recognized. These conflicts will be reviewed by the Steering Committee, who may deem it necessary to limit the role of the member in specific research endeavors in order to insure scientific objectivity. Failure to disclose these conflicts of interest as required may result in the loss of the privilege to participate in PECARN.

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XI. Bylaw Amendments

Bylaw amendments will be determined by the PECARN executive committee and subject to review by the HRSA Program Officer.

XII. Construction and Severability

1. If the Bylaws are in conflict with statute, the statute prevails.

2. If parts of the Bylaws are judged illegal, the remainder prevails.

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POLICY AND PROCEDURES

PARLIAMENTARY PROCEDURES PECARN STEERING COMMITTEE DEFINITION EXPANDED PECARN SUBCOMMITTEE DEFINITIONS OTHER PECARN POLICIES, WORK FLOW, AND PROCEDURES

PARLIAMENTARY PROCEDURES

Introduction

Parliamentary Procedure is a time tested method of conducting business at meetings and public gatherings that allows everyone to be heard and to make decisions without confusion. The PECARN Steering Committee has adopted Robert’s Rules of Order Newly Revised as its basic handbook of operations.

The Basic Rules

1. The rights of the Organization supersede rights of individual members. The organization has the right to make it own rules, which then must be observed by all members. Should a conflict arise between the rights of a member and the rights of the organization to do its business, the rights of the organization prevail.

2. All members are equal and their rights are equal. Those rights are to 1) attend meetings, 2) make motions and speak in debate, 3) nominate, 4) vote, and 5) hold office.

3. A Quorum must be present to do business. A quorum is the number of members who must be present to legally transact business. The number is stated in the Bylaws. The purpose of a quorum is to prevent an unrepresentative group from taking action in the name of the organization.

4. The majority rules. The minority has the right to be heard, but once a decision has been reached by a majority of the membership the minority must respect and abide by the decision.

5. Silence is consent. Those members who do not vote agree to go along with the decision of the majority by their silence.

6. Two-thirds vote rule. A two-thirds vote is necessary whenever you are limiting or taking away the rights of members or whenever you are changing something that has already been decided.

7. One question at a time and one speaker at a time. No motion is in order that does not directly relate to the question under consideration. In addition, once a member has been recognized, he or she has been granted “the floor” and another member may not interrupt him or her.

8. Debatable motions must receive full debate. The presiding officer may not put a debatable motion to vote as long as members wish to debate it. Debate can only be suspended by a two-thirds vote of the members present.

9. Once a question is decided, it is not in order to bring up the same motion or one essentially like it at the same meeting. Such motions should be ruled out of order.

10. Personal remarks in debate are always out of order. The presiding officer must rule all personal remarks out of order. Debate must be directed to motions and not motives, principles, or personalities.

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Procedures for Making and Voting on Motions

The method used by members to express themselves is in the form of moving motions. A motion is a proposal that the entire membership take action or a stand on an in issue. Individual members can 1) call to order, 2) make or second motions, 3) debate motions, and 4) vote on motions.There are four basic types of motions:

1. Main Motions: The purpose of a main motion is to introduce items to the membership for their consideration. They cannot be made when any other motion is on the floor and yield to privileged, subsidiary, and incidental motions.

2. Subsidiary Motions: Their purpose is to change or affect how a main motion is handled and is voted on before a main motion

3. Privileged Motions: Their purpose is to bring up items that are urgent about special or important matters unrelated to pending business.

4. Incidental Motions: Their purpose is to provide a means of questioning procedure concerning other motions and must be considered before the other motion.

The following steps apply to the presentation, delivery, debate, and vote on main motions.

Other types of motions will follow a similar course, with exceptions made for seconding, debate, amendments, and the required vote for acceptance (see the attached chart).

STEP ONE: Presenting a Main Motion

1. Obtaining the floora. Wait until the last speaker has finished.b. Rise and address the Chair or designee facilitating the meeting (herein referred to as Chair).c. Wait until the Chair recognizes you.

2. Make your motiona. Speak in a clear and concise manner.b. State the motion affirmatively (“I move that we…” rather than “I move that we not…”)c. Stay on the subject

3. Wait for someone to second the motion

4. Another member will second the motion or the Chair will call for a second.

5. If there is no second, the motion is lost.

6. The Chair states the motiona. The Chair will say, “It has been moved and seconded that we..” This places the motion before

the membership for consideration and action.b. The membership either debates the motion or may move directly to a vote.c. Once the Chair presents the motion to the membership, it becomes “assembly property,” and

cannot be changed without the consent of the members.

STEP TWO: Expanding on the motion

1. Discussion

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a. At this point, the mover may speak in favor of the motion.b. The mover is always allowed to speak first.c. All comments ad debate must be directed to the Chair.d. Speaking must be within the time limit that has been established.e. The mover may speak again only after other speakers are finished, unless called upon by the

Chair.

2. Putting the question to the membershipa. The chair asks, “Are you ready to vote on the question?”b. If there is no more discussion, a vote is taken.c. On a motion to move, the previous question may be adapted.

STEP THREE: Voting on the Motion

There are five common methods used to vote. The method of vote on any motion depends on the situation and the By-Laws and Constitution. The basic methods are:

1. By Voice—The Chair asks those in favor to say “aye,” those opposed to say “no.” Any member may move for an exact count.

2. By Roll Call—Each member answers “yes” or “no” as his or her name is called. This method is used when a record of each person’s vote is required.

3. By General Consent—When a motion is not likely to be opposed, the Chair says, “If there is no objection….” The membership shows agreement by their silence. However, if one member says, “I object,” the item must be put to a vote.

3. By Division—This is a slight verification of a void vote. It does not require a count unless the Chair so desires. Members raise their hands or stand.

4. By Ballot—Members write their vote on a slip of paper; this method is used when secrecy is desired.

OTHER POINTS

1. The Chair can require a long motion to be submitted in writing.

2. The maker of a motion has first right to speak to it.

3. A member can vote against his or her own motion, but cannot speak against it.

4. A member can modify her or his own motion before the Chair states it. The member can also offer an amendment after her or the Chair has stated his motion.

5. A member can withdraw his or her motion up to the time it has been stated by the Chair, and after that he or she must have permission from the group.

PECARN STEERING COMMITTEE AND EXECUTIVE COMMITTEE DEFINITION

The PECARN Steering Committee (SC) is the scientific governing body of the PECARN. It reviews and approves the research agenda, reviews scientific concepts and protocols and provides scientific oversight. All major scientific decisions are made by majority vote subject to review of the federal Program Officer.

The PECARN Executive Committee (EC) is the primary governing body of the PECARN. It formulates and monitors policies and procedures guiding the research activities and makes all other operational and

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business decisions. All major decisions are made by majority vote subject to of the federal Program Officer. The Executive Committee may appoint Subcommittees and Working Groups as needed.

All participating Nodes and HEDAs must agree to abide by the policies approved by the Steering and Executive Committees.

PECARN SUBCOMMITTEE DEFINITIONS

PROTOCOL REVIEW & DEVELOPMENT SUBCOMMITTEE (PRADS)The purpose of PRADS is to:

a) Provide scientific review of research proposals after the research concepts have been approved by the sponsoring node and the PECARN steering committee. The goal of the review is to provide feedback to the investigator, which will strengthen the proposal, particularly in content areas of research design and data analysis.

b) Inform the PECARN Steering Committee of its findings regarding pending research proposals to assist deliberations regarding proposal approval.

PRADS is advisory to the Steering Committee.

PRADS membership, including the chair will be appointed by the EC. Typically, membership will consist of two persons from each PECARN node and the CDMCC.

PRADS will review research proposals that are developed after the research concept has been approved by the PECARN Steering Committee.

The Chair of PRADS will assign a primary and secondary reviewer to each proposal scheduled for review. The format for the primary and secondary reviews will follow the NIH study section review format. In addition, a representative of the CDMCC will provide a methods/statistics review. Other committee members will read the proposal and be prepared to discuss it; however, their written comments are optional.

Each assigned proposal will be discussed at the PRADS meeting. Presentations are made by the primary, secondary and methods/statistics reviewers. The PRADS Chair will prepare a summary of the key points raised by the reviewers and the committee deliberations. These will be approved by the committee.

PRADS Committee Output: The investigator will receive the PRADS summary and all three written reviews verbatim. Only the PRADS summary will be posted in the eRoom and be made available to the PECARN Steering Committee. The minutes of the committee will contain only the PRADS summary. PRADS reports should be submitted within two weeks of the PRADS meetings.

The prescribed method of review includes an in person meeting of the PRADS Committee. Proposals are typically reviewed at the next PECARN Meeting scheduled after the meeting at which the research concept was approved by the PECARN Steering Committee. At the direction of the Chair of the Steering Committee, PRADS may review research proposals electronically or by conference call in between scheduled meetings.

SAFETY & REGULATORY AFFAIRS AND QUALITY ASSURANCE SUBCOMMITTEE

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Safety and Regulatory Functions:

1) To make recommendations to the Steering Committee concerning specific safety and regulatory issues that arise

2) Streamlining the Process of IRB SubmissionsThe subcommittee’s support role in this regard includes safety and regulatory review of proposals, to anticipate variation in IRB issues across the network and to assist in recommending policies which will aid PECARN researchers in trans-network IRB submissions.

3) HEDA Safety, Regulatory and IRB Technical Support

a. The Subcommittee will review projects, along with the other subcommittees in order to offer recommendations to the investigators and to the Steering Committee in deciding on the merits of projects within PECARN.

b. The Subcommittee will offer problem-solving support. For example, if two HEDA IRBs demand changes which are contradictory, the Subcommittee may offer to help the PI of the Proposal work with HEDA members and the members of the two IRBs.

d. The Subcommittee will also assist in proposal submission by offering anticipatory guidance over ethical issues and IRB process issues. For example, the eRoom site of the Subcommittee has postings of federal guidelines for ethics and IRBs.

e. A basic IRB template for each proposal which will go out to many or all of the HEDAs should be prepared by the proposal’s PI. While responsibility for the contents of the template will be the responsibility of the proposal’s PI, the Subcommittee can offer technical assistance in its creation.

iv. Quality Assurance Functions

Serve as an advisory resource to the Steering Committee on policy related to QA Develop guidelines including a check list of requirements for QA procedures in each protocol Review all protocols for the presence of QA practices and make recommendations to the lead

investigator on meeting the required elements.

FEASABILITY AND BUDGET SUBCOMMITTEE

Definition

The purpose of Feasibility and Budget subcommittee (FAB) is to review proposals submitted to PECARN in order to provide the Steering Committee with recommendations regarding the development of research proposals and provide a technical resource to investigators in preparing grants and study protocols.

The FAB is established by the PECARN Steering Committee, and its actions are advisory to the Steering Committee.

Role of the Subcommittee:

1. To assist investigators in developing protocols that can feasibly work within the confines of budget restrictions.

2. To provide the PECARN steering committee an input and review of the project budget with consideration of current PECARN resources and an assessment of whether the plan for implementation is feasible.

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The subcommittee will develop guidance materials for investigators to assist them in developing budgets and determine the type and amount of resources that they may need.

Review of Research Protocols and Grant Applications:

The subcommittee will review the preliminary budget and general feasibility of the study at the time of the initial submission of the protocol to PECARN. The chair will assign a primary and secondary reviewer to review the protocol and budget; a representative from the CDMCC will review the CDMCC portion of the budget for all projects. The reviewers will prepare written reports that will be discussed by the FAB committee. After review by FAB and presentation to the Steering Committee, a formal written report with recommendations will be prepared and submitted to the RNC PIs for review. When finalized and approved by the RNC PIs, the recommendations will be sent to the investigator.

Budget Revision and Resubmission to PECARN

If budget revision is required, the study PI will work with the NA and assigned FAB member to amend the budget as needed. The revised budget will be resubmitted for review by FAB and the full Steering Committee prior to vote on the protocol. FAB will give input to the Steering Committee prior to this vote. (See FAB Policy)

GRANT WRITING AND PUBLICATION SUBCOMMITTEE (GAPS)POLICY AND PROCEDURE

The GAPS was created by the PECARN steering committee and serves as an advisory committee to the Steering Committee. This subcommittee assists Principal Investigators in developing research grant applications to be submitted for funding, reviews proposals for presentation and publication, and makes recommendation to the PECARN Steering Committee. The GAPS will utilize the operating procedures for the internal peer review process to promote PECARN publications and presentations and to ensure their scientific quality. In addition, the GAPS will assist with timely dissemination of PECARN findings to the scientific and non-scientific communities. Finally, the GAPS will review, critique and help PECARN Principal Investigators develop grant proposals to fund PECARN-related research proposals.

Publication, Presentation and Grant Definitions

The following are covered under this document:

1. Research manuscripts, methodological papers, monographs, book chapters and other PECARN related material to be published in scientific journals and other scholarly literature.

2. Presentations at scientific meetings (oral and poster).

3. Publications of PECARN materials (e.g. books, monographs, training manuals, therapist manuals, summaries of study protocols and trial progress reports).

4. Proposals for grant funding submitted to government or non-government agencies, to support PECARN research activities.

5. Other products for public dissemination including methodology and other know-how or information regardless of the form (e.g. research instruments, computer software, video and audio taped materials) that are produced from PECARN activities.

6. Exceptions:

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a. Materials (e.g. posters, handouts, recruitment cards) or presentations used solely to promote enrollment or inform professional audiences of the PECARN structure, purpose, study design, or research proposals. Such presentations should not include discussion of previously unpublished data and must not result in publication.

b. Press releases: HRSA will provide the Steering Committee with its current policy and the Steering Committee will write a procedure for press releases that is independent of the Publications policy and/or procedures. Press releases should be forwarded to GAPS for archiving and tracking.

c. Data collection instruments, including surveys, intended for use in PECARN studies but not for public dissemination.

General Principles and Procedures1. Grant review. The GAPS will, at the request of investigators, review grant applications being

submitted for external funding. The focus of the GAPS review of grant proposals will be on overall structure of the proposal and quality of the writing.

2. Manuscript review.

a. All presentations and publications, as defined above, based upon data collected or to be collected as part of the PECARN, shall be submitted to the GAPS for review and approval recommendation before submission to journals or professional organizations. Because of the short lead time typically available for abstracts submitted for scientific meetings, it is not expected that abstracts will be reviewed by GAPS prior to submission. Review of abstracts will follow an expedited process outlined in the Authorship Guidelines.

b. Active or associate PECARN members may propose publications or presentations related to PECARN. Participants are required to submit topics for publications and presentations in advance. The processes for proposing manuscript topics and writing teams are detailed in the Authorship Guidelines. Publication plans will be submitted for approval to the GAPS.

c. Manuscripts submitted for GAPS review should, in the opinion of the authors, be ready for journal submission, and should be accompanied by a statement that all authors have reviewed and approved the manuscript. Materials submitted for review will be circulated to all voting members of the subcommittee by the GAPS chair. The chair will assign a primary reviewer from the subcommittee. A methodology/statistics reviewer from the Central Data Management and Coordinating Center will also be assigned. These reviewers will provide a written critique of the presentation or publication, using a standardized review format to be developed separately. The written review will also be circulated among the committee at large. Following group discussion and comment, either in person or via electronic means, the primary reviewer will complete a summary evaluation for the lead author. The members of GAPS will also be asked to vote for approval, approval with minor revisions (subject to re-review by GAPS chair or designee), or approval with major revisions (subject to re-review by the full subcommittee). The lead author will be asked to respond to the critique, with manuscript revisions as appropriate. Once the author and GAPS chair agree the revisions are complete, the GAPS chair will forward a recommendation for approval to the Steering Committee for a vote, along with the original critique and responses. Where manuscript approval is by unanimous vote of GAPS, final approval will be by the nodal PIs. The final decision of the Steering Committee will be communicated to the lead author and writing team.

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d. It is expected that reviews will be completed in a timely fashion. The expected turn around time will depend on any deadlines, but generally should be within 2 weeks of receipt of the material by the chair.

3. Manuscript submission. Once a manuscript has been approved by the Steering Committee or Nodal PIs, it may be submitted for publication. The lead author shall notify the GAPS chair of the date of submission, and will provide updates on the status of the manuscript. Final versions of manuscripts should be sent electronically to the GAPS chair for archiving.

a. All NIH-funded studies must comply with the NIH Public Access Policy. Under a new federal law, the NIH is requiring that “all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.” (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. Other information is available at http://publicaccess.nih.gov/FAQ.htm#c2, and http://publicaccess.nih.gov/)

b. If a manuscript is revised prior to resubmission (either to the same or a different journal), the revised manuscript must be reviewed by the GAPS chair or designee prior to resubmission. If the revisions are substantial, the GAPS chair may require re-review by the full subcommittee prior to resubmission. In the event of full subcommittee re-review, the Steering Committee or nodal PIs will be asked to make a final determination on the manuscript following the same procedure as described above for initial submissions.

4. Abstract submission and review.

a. Once an abstract is approved by a nodal PI, it may be submitted for the appropriate meeting. The lead author shall notify the GAPS chair of the date of submission, and will provide updates on the status of the abstract.

b. GAPS will provide lead authors of all abstracts a checklist of requirements for posters and presentations. GAPS will also develop and maintain templates for posters and presentations to maintain consistent PECARN branding.

c. Prior to the meeting where an abstract will be presented, one of the nodal PIs must review and approve the poster or presentation. The purposes of this review are to ensure:

i. consistent appearance to optimize PECARN “branding”ii. proper accreditation for funding agencies

iii. no inappropriate political or other content

d. Recognizing that last minute changes may be unavoidable, the presentation need not be in final form. However, sufficient material for meaningful review must be provided, including title slide/acknowledgments, results, and conclusions.

e. The deadline for submission of the poster or presentation to nodal PIs will be determined by the nodal PIs; GAPS recommends two weeks prior to the meeting. GAPS will send the nodal PIs a list of abstracts at least one month before the meeting to allow them to plan for the upcoming review, divide up the workload, and contact the authors.

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f. The nodal PI approving a poster or presentation may be one of the listed authors. However, if a nodal PI is the first or senior author, another nodal PI must review and approve. GAPS members will be available to review posters or presentations at the request of the nodal PIs.

g. Final versions of abstracts should be sent electronically to the GAPS chair for archiving.

5. Studies where a group that is not formally part of the PECARN analyzes PECARN data over which the network retains control are subject to the same procedures unless another procedure is mutually agreed upon and codified in a letter of agreement.

6. In the case of pharmaceutical collaborators, the Clinical Trials Agreement between sites and the pharmaceutical collaborator(s) should specify that these guidelines would be followed. Alternative procedures may be followed if all parties (including the Steering Committee) mutually agree upon modifications to those guidelines.

7. In the case of collaborative studies with co-sponsoring agencies or other study groups, the letter of agreement must reflect that the guidelines of the PECARN Network will be followed unless all parties agree on the modifications.

8. Proper acknowledgment of PECARN and the funding agency(ies) is required in all publications and presentations.

9. Any decisions of the GAPS may be appealed to the Steering Committee.

10. These procedures will be reviewed on an ongoing basis and modified as necessary. Revisions may be approved by a majority vote of the subcommittee, and then forwarded to the Steering Committee for final approval.

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STANDARD OPERATING POLICY AND PROCEDURE FOR DEVELOPMENT AND APPROVAL OF RESEARCH CONCEPTS AND

PROTOCOLS

1. PURPOSE1.1. The purpose of this policy is to provide guidance for PECARN investigators and others involved in

PECARN research regarding the development, submission and approval process of a research concept and a research protocol.

2. POLICY2.1. This document describes the approved method of initiating a PECARN research project. Any changes to

this process must be approved by the PECARN Steering Committee or the Nodal PI group.

3. SCOPE3.1. This document applies to all investigators, nodal administrators and others involved in PECARN-related

research and to all participating sites.

4. DEFINITIONS4.1. Nodal Principal Investigators: Investigators named on the HRSA cooperative agreements at each

PECARN node and the CDMCC.

5. RESPONSIBLE PARTIES5.1. A PECARN investigator or an external investigator is responsible for preparing the initial draft of the

concept or protocol, in conjunction with participating PECARN nodal investigators, subcommittees, subject matter experts, the CDMCC, biostatisticians, information technology/database experts, and others, as appropriate.

5.2. The investigator who initiates the concept or protocol is responsible for assuring that the concept or protocol meets all regulatory requirements, and is ethically and scientifically sound.

6. PROCEDURES

6.1. Research Concept 6.1.1. An investigator with a research concept drafts an initial written concept proposal and, through the

principal investigator of the submitting Node, requests review by the Federal Program Officer in order to:

Assess the importance of the research question and its general appropriateness for PECARN

Determine whether the research topic addresses an identified priority (e.g. PECARN research agenda)

6.1.2. The Nodal PI in consultation with the Federal PO may then identify a mentor, subject matter expert or consultant as necessary to further develop the concept within the node. The Nodal PI’s role is to oversee the nodal review of the concept and to:

Determine, in consultation with the Federal Program Officer, the general feasibility of conducting the proposed study within PECARN

Assist the investigator in refining the science of the concept proposal Assist the investigator in navigating the PECARN protocol development process

6.2. Concept Submission, Presentation and Review6.2.1. After nodal review and approval, the investigator will submit a 2-page concept paper to the

PECARN Steering Committee (SC). The deadline for concept submission will be two weeks prior to the next scheduled SC meeting. The investigator will attend the SC meeting (Meeting #1)

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and present the research concept in person. The 2-page limit was adopted in order to encourage brevity, clarity, and focus. Appendices and references may extend the 2-page limit. If the concept paper exceeds 2 pages, (excluding appendices and references) the PECARN Secretary will return the submission to the investigator for revision.

The concept paper should address the following: Why the proposed topic is important to EMSC Why the study requires the PECARN network Background in brief Specific aims Methodology in brief Subject population Sample size requirements

Note: Concept papers should be single-spaced using 11-12 point standard type and one-inch margins.

The concept proposal submission should include a face sheet. This face sheet must include the names of all project investigators and attestation that the concept proposal has been reviewed and approved by the submitting node. See Attachment A.

A cover page must also be submitted with the concept proposal. The cover page should identify a target external funding agency. The cover page should also include the institution of the lead investigator, along with the investigator’s address, telephone and fax numbers and email address. An example of cover page is at the end of this document. See Attachment A.

6.2.2. The concept paper should be submitted electronically to the PECARN Secretary at least 2 weeks prior to the SC meeting in which it will be discussed. No budget is necessary at this step.

6.2.3. As a general rule, no more than four new concepts should be submitted for review at a given SC meeting. This limit may be exceeded if all Nodal PIs, in consultation with the Federal Program Officer, agree. Each node is guaranteed the option of forwarding one concept per meeting. If a node has more than one concept to submit, they must check with the PECARN Secretary to verify the number of expected submissions. The PECARN Nodal PIs have the right to refuse to accept more than one concept per node if the total number of submissions per meeting exceeds four.

6.2.4. The Investigator will present the research concept at the PECARN SC meeting. The purpose of the presentation, which may or may not use a PowerPoint format or equivalent, is to encourage scientific dialogue, to develop a broad understanding of the proposal among SC members, to review and consider the scientific merit, and to address questions not covered in the presentation, etc. This presentation will be approximately 10-15 minutes in length, with approximately 45-50 minutes of subsequent discussion.

6.2.5. After the conclusion of the presentation, the SC will vote by secret ballot to determine whether or not the concept should be endorsed for further development into a PECARN protocol. A 75% majority of the PECARN voting membership is required for concept endorsement. Abstentions will not count in determining whether a majority has been reached. The majority required will insure that there is not only recognition of scientific merit, but wide enthusiasm for developing the concept into a research protocol for implementation in PECARN. SC approval by 75% or more implies that the Investigator will proceed with protocol development. Concepts that receive 50-74% approval may be revised and resubmitted to the SC for discussion and reconsideration at a future meeting at the discretion of the Investigator. Concepts receiving less than 50% approval will not be reconsidered by the SC.

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6.3. Protocol Development6.3.1. Once the research concept is approved, the investigator will identify a group of co-investigators

or collaborators, and with the help of this group, develop the concept into a research protocol. The protocol can take the format of a standard protocol as might be submitted to an IRB or as a grant. Irrespective of the format, the protocol/grant should contain sufficient detail about the proposed study such that the Protocol Review and Development Subcommittee (PRADS) and SC members may assess scientific merit and feasibility. The essential elements of a protocol to be submitted to the Steering Committee are described in Attachment B (Protocol Template: A Guideline for Writing a Clinical Protocol for PECARN). Investigators are required to discuss study design, protocol development and statistical methods with the CDMCC. The length of the protocol is not limited.

Throughout the rest of this policy, the word “protocol” is used with the understanding that the format to be submitted can be either in IRB-type protocol format or in grant format.

6.3.2. The protocol should also contain a preliminary budget and budget narrative. The investigators must work with a PECARN Nodal Administrator to develop the draft budget in accordance with the Feasibility and Budget (FAB) guidelines see FAB Protocol Review Policy). Investigators are required to consult FAB, and strongly encouraged to consult other PECARN subcommittees.

6.3.3. After the protocol is preliminarily developed by the study group, investigators are required to meet (preferably in person) with the CDMCC to further develop the protocol. While this should occur at least 6 weeks before submitting the protocol to the SC, it is important that the scientific details of the protocol be sufficiently developed prior to the CDMCC visit to enable the group to meet the goals of refining study details. The CDMCC will assist the investigator in formatting the protocol properly if in the format of an IRB-type protocol and will provide boilerplate material for certain portions of the protocol.

6.4. Protocol and Budget Review and Development by all Subcommittees 6.4.1. The protocol is then submitted to all members of the SC and all subcommittees for a scientific

review at the next PECARN SC meeting (Meeting #2). The protocol must be submitted to the PECARN Secretary four weeks prior to the meeting. The Secretary will distribute the protocol to all subcommittees and SC members. Subcommittees and SC members will conduct a detailed review of the protocol. It is preferable, although not required, that the investigator present the protocol at Meeting #2.

6.4.2. After the PECARN meeting at which the protocol is reviewed, the chair of each subcommittee (PRADS, QAS/SRAS, and FAB as applicable) is required to submit two documents to the PECARN secretary. The first document should be a confidential, detailed, written summary of the subcommittee’s commentary on the protocol. The subcommittee chair will submit this document to the PECARN Secretary within 2 weeks of the date on which the protocol was reviewed. The document will be distributed by the Secretary to the investigator only. The investigator may share the summary with other members of his/her team at their own discretion. Each subcommittee chair will also submit a shorter written summary of their subcommittee’s commentary on the protocol. This document will be made available to all SC members to aid in reviewing the subsequent revised protocol, and in determining if the investigator has been responsive to subcommittee critique. The difference between the two documents is that one document has detailed commentary and is intended for the investigator; the other is a brief, general summary of the issues intended to assist the SC in determining whether or not to approve the protocol. These documents could be identical at the discretion of the subcommittee chair based on the sensitivity of the commentary. The Secretary will post the general summary of each subcommittee in eRoom and make it available for the SC in time for the next protocol review.

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6.5. Protocol and Budget Refinement6.5.1. After the subcommittee review, the investigator may opt to return to meet in person with the

CDMCC to help revise and refine the protocol. A member from each of PRADS and FAB may be identified to work with the investigator as needed to address the subcommittee comments and further develop the protocol and/or budget.

After receiving the reviews, the investigator will make appropriate revisions to the protocol. While subcommittee recommendations are not binding, the investigator should give strong consideration to the comments that were provided. The investigator must submit the revised protocol 2 weeks prior to the next SC meeting. The investigator should highlight where substantive changes were made, particularly in regard to summary comments from the subcommittees. It is also required that the investigator(s) submit point-by-point responses to the major summary comments of subcommittees, as one would do in resubmission of a manuscript. It is the responsibility of each subcommittee chair to review the subcommittee's feedback as well as the investigator's response and be prepared to provide the Steering Committee with an assessment of the responsiveness of the revised protocol, and/or any remaining issues from the perspective of the subcommittee.The SC will have the opportunity to review the protocol and related documents and assess the investigator’s response to subcommittee comments before the vote on the protocol.

6.6. Steering Committee Approval6.6.1. Investigators may submit a protocol for review at the meeting immediately following PRADS

review (meeting #3), or may postpone until the next meeting (meeting #4). Investigators may not delay protocol submission later than two meetings after the PRADS review, unless special circumstances apply.

6.6.2. The investigator should present the revised protocol at the SC meeting, either in person or remotely. Protocol presentations should be 10-15 minutes in duration, using a Power Point presentation or equivalent, as appropriate. This presentation will be followed by approximately 45-50 minutes of open discussion. The investigator will clearly summarize the goals, aims, methods and other aspects of the protocol in detail. At the close of this discussion, a SC vote will be held by secret ballot. Protocols receiving 75% support would be approved for further development of a grant application or for internally-funded implementation. Protocols receiving 50%-75% approval should be revised and resubmitted at the following SC meeting. Protocols receiving less than 50% approval will not be considered further for PECARN implementation. Abstentions will not count in determining whether a majority has been reached.

6.6.3. If the protocol is approved, the FAB subcommittee will continue to help address any feasibility issues with the investigator. In addition, as indicated above, the protocol will likely require more detailed revision prior to study implementation if the study is ultimately funded.

6.7. Grant Application6.7.1. Following development and approval of a PECARN protocol, unless the protocol will be

implemented with internal resources, the investigator prepares a grant application. As noted prior, the protocol that is submitted for Steering Committee approval can take the form of a grant but must include the essential elements, as noted above, that are necessary to complete a thorough scientific review.

6.8. PRADS is available, as are all the subcommittees, to help develop and rigorously review the grant application following protocol approval by the SC.

6.9. Approval of Grant Application6.9.1. Submission of the grant proposal to an external agency requires approval by the Executive

Committee. The grant application must be submitted electronically to the PECARN Secretary at

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least two weeks before the external grant application deadline. It must be sufficiently complete that changes made during the last two weeks are not scientifically or fiscally substantive.

6.10. Protocol Development: Expedited Review Process6.10.1. Proposals that have not been endorsed previously by the SC may move through an expedited

review process in exceptional circumstances such as short turn-around RFAs or other pressing grant deadlines. The expediency will be determined by the Executive Committee and Federal Program Officer. This process cannot be used to meet routine grant cycle deadlines. The expedited process should be conducted as follows:

6.10.2. Investigators must submit a 2-page concept paper for the Federal Program Officer review and Executive Committee review. Upon approval of concept by the Federal Program Officer and Executive Committee, the concept can be submitted to the SC for a vote as time allows. SC members will vote on these concepts electronically if the timing does not coincide with a PECARN meeting.

6.10.3. A 75% approval of the SC membership or unanimous approval by the Executive Committee is required for concept approval..

6.10.4. If the concept is approved, investigators should immediately schedule opportunities to work with CDMCC and FAB representatives, and are encouraged to work with all subcommittees, on the development of a full protocol/grant and budget. It is understood that the submission will potentially take the format of a grant due to time constraints. However, the protocol/grant submitted must contain sufficient detail to thoroughly evaluate the science (particularly the methods) of the study. The protocol/grant must be submitted to PRADS and the SC for consideration electronically or at a PECARN meeting. The timing will be determined by the Nodal PIs.

6.10.5. PRADS will review the protocol/grant at the subsequent meeting if time allows, or electronically if necessary. A representative of PRADS will provide confidential feedback to the investigator after the subcommittee meets. This feedback will highlight concerns identified and suggestions for strengthening the scientific aspects of the protocol/grant application.

6.10.6. An EC vote will be conducted, either in person or electronically, to approve the protocol/ grant. At least 5 of the 7 EC members must approve for the protocol/grant to be endorsed. This is a vote to approve for the investigator to continue toward full grant submission to the EC.

6.10.7. Investigators will work with representatives of CDMCC, FAB and other relevant subcommittees to complete the full grant. The full grant will be submitted for EC vote at least 2 weeks prior to the grant submission deadline. The SC vote will be conducted, either in person or electronically. At least 5 of the 7 EC members must approve for the grant to be endorsed.

6.10.8. In exceptional circumstances, parts of this process may be obviated, as will be determined and resolved by the Federal Program Officer.

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Mandatory interactions

PECARN Research Concept and Protocol Development Process

LEGEND

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If approved, protocol may be developed into grant application

Project concept initiated by PECARN or Non-

PECARNInvestigators or a

Submit grant application for funding

Federal Program Officer review

and approval of project concept

Steering Committee final approval of grant application

(by electronic vote if necessary)

Concept approval by Steering Committee (Mtg #1)

Subcom review preliminary protocol. (Meeting #2)Subcommittee Chairs send summary to investigator within 2 weeks of meeting.

Protocol review/vote for approval by SC (Meeting #3)

Preliminary protocol developed and submitted 4 weeks prior to SC meeting

Investigator refines protocol incorporating subcommittees’ recommendations.

Meet with CDMCCConsult FAB

2 weeks prior to subsequent SC meeting:Investigator submits revised protocol to SC

STANDARD OPERATING POLICY AND PROCEDURE FORFINALIZATION AND AMENDMENT OF PECARN PROTOCOLS

1. PURPOSE1.1. The purpose of this policy is to provide guidance for PECARN investigators regarding the development of the final study protocol as well as describing the process for creating and submitting study amendments.

2. POLICY2.1. An ethical and scientifically sound clinical research protocol is the foundation of all successful clinical research. A clinical protocol must clearly define the research population, the procedures that must be followed to ensure the collection of valid and trustworthy data, and outline the responsibilities of each member of the study team. A clinical protocol must incorporate all applicable regulatory requirements and guidances that are available to PECARN, as well as counsel from appropriate subject area and technical experts (clinicians, statisticians, database developers, etc.) including those outside the PECARN network, when appropriate.

2.2. The suggested format for writing an initial clinical protocol is detailed in The Development and Approval of Research Concepts and Protocols policy. The policy described here represents the steps in between endorsement of an initial protocol and implementation of a final protocol, as well as protocol amendments thereafter.

2.3. Protocol amendments may be required during the course of the study to accommodate changes in study design, subject inclusion criteria, and risk profile. The lead investigator will initiate protocol amendments. Protocol amendments may require substantial changes to data collection systems, and this should be considered whenever protocol amendments are indicated. Protocol amendments must be submitted to the CDMCC for approval prior to distribution to the network.

2.4. Protocol amendments must be reviewed by all involved IRBs. Changes to the protocol may not be implemented at an institution without approval of the lead investigator, the CDMCC and the IRB at each institution.

2.5. Compliance with the approved clinical protocol is essential in ensuring that the subjects’ rights and well-being are protected. Any deviation from the approved protocol is a violation of the protocol, and must be reported to the CDMCC as described in the Manual of Operations for the study.

3. SCOPE3.1. These policies and procedures apply to all PECARN-related research studies, to all investigators conducting and participating in PECARN research, and to all participating sites.

4. DEFINITIONS4.1. The HEDA Investigator: The investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

4.2. The Lead Investigator: The investigator who received official Steering Committee approval to oversee and provide leadership for the study, and who is the grant holder in studies receiving extramural funding.

4.3. The Site Investigator: The investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN site.

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4.4. Nodal Principal Investigators: Investigators for the HRSA cooperative agreements at each PECARN node and the CDMCC.

5. RESPONSIBLE PARTIES5.1. The lead investigator is responsible for finalizing the protocol, in conjunction with participating investigators, subject matter experts, the CDMCC, biostatisticians, information technology/database experts, and others as appropriate. The CDMCC will finalize and version the protocol in a standard format.

5.2. The lead investigator is responsible for ensuring that all participating investigators comply with the approved clinical protocol.

5.3. The lead investigator is responsible for assuring that the protocol meets all regulatory requirements, and is ethically and scientifically sound.

5.4. The site investigator will generally be required to sign an investigator responsibility form which clearly outlines investigator responsibilities in the study.

5.5. The HEDA investigator is responsible for assuring that the site investigator provides adequate study-specific oversight and will assign a new site investigator if the original site investigator is unable to continue in his/her role.

6. PROCEDURES6.1. Writing the Final Clinical Protocol – If a grant, instead of a protocol, was written and approved by the PECARN SC, the final protocol will need to be developed after the grant has been funded. Usually, this will entail filling in details that may not have been worked out at the time of the grant submission.

If a clinical protocol was developed and approved by the PECARN SC, then the approved protocol may still need to be refined and augmented to create a final clinical protocol. This decision should be made by the Lead Investigator and the CDMCC. Protocol refinement at this stage, if required, may involve finalizing data elements and other fine details of the protocol. Specific elements of the final protocol template are attached in this policy. The final protocol may not be substantially different from either the grant or the original protocol that was approved by the SC without being approved by the Nodal PIs and in consultation with the Federal Program Officer.

6.1.2. If a grant was prepared instead of a protocol, the lead investigator and CDMCC will transform the grant into a clinical protocol. The CDMCC will assign the protocol a version number and effective date. This will become the final protocol.

6.1.3. Protocols for Investigational New Drug (IND) and InvestigationalDevice Exemption (IDE) clinical studies may be submitted to the FDA for formal review as part of IND or IDE submissions. The protocol may also be sent informally to the FDA for preliminary review (pre- IND or pre-IDE) prior to an IND or IDE submission. The CDMCC will advise the investigator as needed.

6.1.4. The CDMCC will post the protocol in the study eRoom in pdf format. Sites may not make any changes to the final protocol after this point without approval of the CDMCC. The CDMCC will maintain a copy of the IRB approval letter(s) from participating sites and place these documents in the IRB tracking system in eRoom. The participating site will maintain documentation of all IRB approvals and correspondence as well.

6.1.5. The site will not implement the protocol until final IRB approval is obtained, the protocol has been submitted to the FDA (if applicable), and the required 30-day response period has passed or an

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FDA approval letter has been received. Once FDA review is complete the protocol can be submitted to the IRB. Certain protocols must be submitted to other external and/or internal regulatory authorities for review before or concurrently with PECARN IRB/FDA submission.

6.1.6. The site will retain approved clinical protocols and their attachments, subsequent revisions and associated correspondences with regulatory authorities, as well as any other documents required, and keep them filed in the Essential Documents Binder.

6.2. Protocol Amendment Creation, Review and Approval

6.2.1. The lead investigator will make any necessary changes to the protocol in conjunction with the CDMCC, as necessary during the conduct of the study. Major changes may need to be approved by PECARN Steering- and/or sub-committees. Any revision to the original protocol or subsequent version of the protocol that substantially affects the scientific details of the study, safety of the subjects and/or significantly affects the scope of the investigation must be submitted to all site IRB(s) and the FDA (as applicable). The CDMCC will assist the lead investigator in this process. Protocol amendments must be written in the same format as the original protocol, highlighting the new elements. The CDMCC will amend the version number to reflect subsequent changes to the protocol after approval of the original version.

6.2.2. If changes to a protocol result in necessary changes to informed consent, the lead investigator will make associated changes to the informed consent form and will instruct participating sites to submit changes to their local IRBs.

6.2.3. Protocol changes made to eliminate an immediate hazard to subjects may be implemented immediately, provided that the FDA and the IRB are notified as soon as possible afterwards, but no more than 5 days after the change is implemented.

7. REGULATIONS21 CFR 312.20 Requirements for an IND21 CFR 312.21 Phases of an Investigation21 CFR 312.23 IND Content and Format21 CFR 312.30 Protocol Amendments21 CFR 312.62 Investigator Recordkeeping and Record Retention21 CFR 314.126 Adequate and Well Controlled Studies21 CFR 812.25 Investigational Plan21 CFR 860.7 Determination of Safety and Effectiveness21 CFR 812.35 Supplemental Applications21 CFR 812 140 RecordsICH E6 2.2, 2.4 –2.6, 2.10, 2.11The Principles of ICH GCP

ICH E6 4.5 Compliance with ProtocolICH E6 4.9 Records and ReportsICH E6, 5.1 Quality Assurance and Quality ControlICH E6 5.4 Trial DesignICH E6, 5.5 Trial Management, Data Handling and Record KeepingICH E6, 5.23 Multicentre TrialsICH E6 6.0 Clinical Trial Protocol and Protocol Amendment(s)ICH E8 General Considerations for Clinical Trials (December 1997)ICH E9 Statistical Principles for Clinical Trials (September 1998)ICH E10 Choice of Control Group and Related Issues in Clinical Trials(May 2001)

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Supplement to the FINALIZATION AND AMENDMENT OF PECARN PROTOCOLS policy.

The following protocol finalization guideline describes what the lead investigator needs to include in the study protocol after a grant is approved to fund the study. This final protocol will be submitted to the IRB and is generally more detailed than the earlier version submitted to the PECARN Steering Committee. The goal of protocol finalization is to describe the study in a clear, concise, detailed written document that IRBs may review.

A. Elements of the final protocol

1. Title Page

2. Introduction and PurposeThe basic work leading to the study should be reviewed. A clear statement of the specific aims (and hypotheses) of the research should be included. State primary/secondary study outcomes here.

3. Background and RationalePrevious clinical work should be reviewed here and a description of how the current protocol extends existing work on the topic should be provided. The investigators should detail how successful completion of this protocol will lead to improved care of children. If the study is a drug or device study, relevant information might include pharmacological, toxicological and other biological properties of the drug/biologic/medical device, and previous efficacy and safety experience should such exist. The investigators should discuss any preliminary studies performed by the investigational team. This section may be shortened from what is in the grant and reduced to the essential elements that an IRB needs to know.

4. Study DesignThis section provides a thorough overview of the study design, including how the study objectives will be achieved. This section will describe the type of study (i.e., double-blind, multicenter, placebo controlled, etc.), the specific treatment groups and number of study subjects (in each group) and number of investigative sites. A brief description of the methods and procedures to be used during the study will be provided, but will be expanded upon in the Procedures section.

5. Study OutcomesThis section should include a description of primary and secondary outcomes or endpoints, how they will be measured and a schedule of assessments over time. This section should also justify any additional measures (not related to a primary or secondary outcome) to be addressed in the main analysis.

6. Study Population / Subject EligibilityThis section states the number of subjects required to be enrolled in the study at all sites. There should be a brief definition of the nature of the subject population that is required. Accrual projections and duration of the study should be described.

Inclusion Criteria: This section describes the criteria each subject must satisfy to enter the study, including but not limited to: age, sex, race, diagnosis, method of diagnosis, diagnostic test result requirements, concomitant medication requirements, severity of symptoms and signs of the disease, the ability to perform study requirements and to give informed consent. The criteria should be detailed sufficiently to provide the investigative site the information needed to recruit appropriate subjects. Care should be taken to develop these criteria so that they include the desired target population and not be overly inclusive or exclusive.

Exclusion Criteria: The criteria that eliminate a subject from the study population should be listed. These may include but are not limited to: previous medical history, pregnancy, childbearing potential, current or

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past therapy, severity of disease, current medical conditions, a minimum of time since the last clinical study, drug or alcohol abuse, and upper limits of laboratory tests that will disqualify potential subjects.

7. Procedures and Data ElementsThis section details the plan of action, procedures, and methods to be used during the study. The investigators should describe if and how the methods in this study are novel or innovative.

The activities for each phase of the study are described. Include a clear outline of the study activities (collecting data, administering tests, performing clinical measures, recording data) This section should be sufficiently detailed for PECARN sites to understand the specific procedures associated with the study. Very specific details will likely go into the Manual of operations, but in general, the procedures should be outlined in enough detail that a person could conduct the study from the protocol. For example, “the research coordinator will abstract the data from the chart and enter it into an electronic data collection system”. This is sufficient for the protocol. Additional information that might be in the Manual of Operations would be: time of ED admission will be abstracted from the triage note. The CDMCC can assist with the amount of detail that should be included.

Screening, Enrollment and Randomization: Describe how patients will be identified, approached, screened, randomized, and enrolled. A flow diagram is helpful.

Diagnostic and Laboratory Tests: Detailed methodology is described for laboratory or diagnostic tests. Any unusual tests or tests required specifically for the study should be described. If the tests are part of standard of care, this should be described. If the tests are not part of standard of care, this should be explained in detail.

Data elements: A general description of essential data elements that will be collected should be included in this section. It is important to be thorough yet not too specific as data elements may change slightly over the course of a study, and overly specific information may require formal amendment. The goal is to describe to the IRB the main types of data that will be collected, knowing that there will be more specifics inside the Manual of Operations. For example, “we will collect demographics, ED laboratory results, all CT scan findings, admission information, a brief medical history, treatment received in the ED, medications administered in the ED, LOS, and follow up information for patients who were discharged from the ED.” Follow-up procedures (if applicable): Describe the follow-up procedures (e.g. telephone follow up calls, returns for evaluation), and their timing.

8. Study Treatment (if applicable)All interventions for the study such as treatments, schedules, and specific guidelines for study subjects should be described. Specific information for drug studies includes:

Dosing schedule (or investigational device use): The details concerning dose, frequency, and duration of the experimental treatment should be provided here. If placebos are part of the treatment plan, the details of their administration are also described in this section. If applicable, the drug, doses, frequency, and duration of concomitant treatment required in addition to the experimental medication are listed here.

Study drug/device supplies and administration: The Lead Investigator should determine who is going to provide the study medication (e.g., pharmaceutical company, local laboratory) and note this here. The Sponsor must be able to assert that the experimental medication has been manufactured following all regulations (i.e., by Good Manufacturing Practice or GMP). This is especially important if the investigational product is manufactured in a local laboratory without the participation of a biotech or pharmaceutical company. Details of the product stability, storage requirements and dispensing requirements should be provided if there are unusual needs.

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Dose modification for study drug toxicity: Rules for changing the dose or stopping the study drug should be provided. If the involvement of an Investigator and/or an Independent Data Monitoring Committee and/or the Sponsor is/are required prior to stopping the drug or changing the doses, this should be noted in this section. Possible drug interactions: The foreseeable interactions of the study drug with other medications or herbal preparations should be noted. Concomitant therapy: The drugs that are permitted during the study and the conditions under which they may be used are detailed here. Describe the drugs that a subject is not allowed to use during parts of or the entire study.

Discontinuation from study treatment: The specific reasons from early discontinuation and the definition of treatment failure should be defined. Discontinuation due to other causes (e.g., adverse events, withdrawal of consent, etc.) should also be described.

Blinding/Unblinding procedures: If the study employs a blind on the Investigator and/or the subject, describe how this will be accomplished. If the study is blinded, the circumstances and the mechanism for unblinding to occur should be given.

Conditions for a subject to withdraw from the study should be described here.

9. Data Management (The CDMCC will suggest a plan for this section) This section will include details on the collection and submission of data to the CDMCC.

Data quality: A statement about data quality and what methods will be used to assure data accuracy should be included. Describe double data entry, validation plans and internal audits as applicable to the study.

10. Data Analysis (prepared in conjunction with CDMCC)The details of the statistical approach to be followed in the study are described:

Sample size: Describes the sample size required and how the sample size was determined, including the assumptions made in making this determination.

Efficacy endpoints: Before the study begins, the endpoints need to be clearly and completely defined. These can be grouped as primary and secondary endpoints.Safety endpoints should also be defined before the study begins (if applicable).

Statistical analysis: Details of how the results will be analyzed and reported are described in this section; specifically, statistical tests to be used to analyze the primary and secondary endpoints that were defined above, a definition of the level of significance, statistical tests to be used, and the methods used for missing data. The method of evaluation of the data for treatment failures, non-compliance, and subject withdrawals is presented. If an interim analysis will be performed, the rationale and conditions are described. Any statistical concerns to correct for interim analyses should be presented.

Pharmacokinetic (PK) analysis: If applicable, the statistical considerations for analyzingPK data are described here.

11. Human Subjects Risk/benefit assessment: Provide a discussion of major known risks of the treatment(s) and testing procedure(s). Specific risks associated with the investigational product and any control(s) should be included. Details of how known risks will be mitigated or minimized should be provided. What benefits exist for the subjects should be discussed.

Consent Process: This section should detail the consent/assent process or its substitute. If the lead investigator is requesting a waiver of informed consent, this should be stated and justified.

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12. Study Monitoring & Quality Assurance-(CDMCC will suggest a plan for this section). All clinical studies require monitoring commensurate with the degree of risk involved in participation as well as the size and complexity of the study. The plan provided in the protocol should be quite general, since funding resources may not be known. A general description will also help avoid amendments to the protocol if the monitoring plan requires changes. Detailed plans will be provided in the separate data management and site monitoring plans. The protocol should outline enough of a plan to display commitment in the areas of human subject protection and data quality without providing details that would not allow for flexibility. Describe the type of site monitoring and describe quality assurance plans in general. Include a general description of the type of study monitoring visits (initiation, interim, and close-out).

Describe record retention requirements including details of how long the study data and files need to be stored and how and when Investigators will be informed when the files can be destroyed. The right of the FDA, IRB, and representatives of the Sponsor to verify and inspect/audit the study data is presented here.

13. Organization of the project and capabilities of the investigators. The investigators should briefly explain the organizational structure of the investigative team, including plans for mentorship, where appropriate. This section should briefly demonstrate the expertise of the team, including appropriate references, and should describe any special environments (e.g. basic science laboratory) needed to conduct the research. Names should be omitted unless absolutely necessary because any subsequent investigator name changes will require an amendment.

Informed consent process: This section should describe the consent/assent process. It should include a statement that the elements of informed consent comply with FDA regulations, the ICH Guidelines for Good Clinical Practice (GCP) and/or other guidelines.

14. Adverse Events-CDMCC can assist with language for this sectionDescribe procedures for reviewing and reporting adverse events (expected and unexpected) that occur during the study. Include a detailed description of expected adverse events from previous experience with the investigational product, if available. Include a description of the procedures used to evaluate an adverse event and the time constraints for reporting the different types of adverse events.

Reporting serious adverse events: The details of serious adverse event reporting should be described including contact information for telephone and/or fax reporting.

15. Investigational Product ManagementInvestigational product description and packaging: All ingredients and the formulation of the investigational drug/biologic and any placebos that are used in the study are described. The precise dosing that is required during the study and method of packaging, labeling, and blinding is described. The method of assigning treatments to subjects and the subject identification code numbering system is detailed. If applicable, the method of blinding to make the test treatments indistinguishable should be explained. The method of drug/biologic coding, code storage, and code access is described. If a third party such as a pharmacist will be dispensing or blinding the investigational product, specific instructions should be supplied.For investigational medical devices, the device specifications and appropriate clinical use are discussed. The method of packaging, labeling, and blinding (if applicable) is described. The method of assigning treatments to subjects and the subject identification code numbering system is detailed.

Stability and storage requirements: These should be detailed enough so that the pharmacist or other designee who stores and dispenses the investigational product knows what is required. Explicit instructions for the storage of the investigational products are listed here.

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Investigational product accountability: Instructions for the receipt, storage, dispensation, and return shipping of the investigational products are described here. FDA regulations require a complete accounting of all investigational products received, dispensed, and returned/destroyed.

16. AppendicesThis section includes copies of the informed consent form/assent form; and any other documents referenced in the clinical protocol.

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FEASIBILITY AND BUDGET REVIEW

1. PURPOSE1.1. The purpose of this policy is to provide guidance for PECARN investigators and others involved in

PECARN research regarding the development, submission and approval process of a project budget

2. POLICY2.1. This document describes the approved method of developing a budget for a PECARN research project.

Any changes to this process must be approved by the PECARN Steering Committee or the Nodal PI group.

3. SCOPE3.1. This document applies to all investigators, nodal administrators and others involved in PECARN-related

research and to all participating sites.

4. DEFINITIONS4.1. Nodal Principal Investigators: Investigators named on the HRSA cooperative agreements at each

PECARN node and the CDMCC.

5. Subcommittee Quorum: 5.1. A quorum of the subcommittee will be considered when at least one member or alternative from

each node and the CDMCC are represented.

6. RESPONSIBLE PARTIES6.1. A PECARN investigator or an external investigator is responsible for preparing the initial draft of the

budget, in conjunction with participating PECARN nodal investigators, subcommittees, subject matter experts, the CDMCC, and others, as appropriate.

7. PROCEDURES

7.1. Developing the Proposed Budget: Investigators will work with FAB subcommittee representatives throughout the protocol and grant development process. The preliminary budget will be completed by the PI, in cooperation with the nodal administrator of his/her sponsoring node, and a selected member of FAB.

7.2. A preliminary budget and brief budget narrative will be submitted to FAB at the time of the initial submission of the protocol to PECARN. This will occur 4 weeks prior to the Steering Committee meeting.

7.3. The template for this preliminary budget is attached (Appendix 1). The preliminary budget must include an accurate accounting of all costs necessary to complete the study.

7.4. If there is a known cap on total grant dollars at the time of preliminary budget submission (e.g. already queried the NIH and were not given permission to exceed the cap), the preliminary budget must also identify areas where the full budget could potentially be trimmed. This will allow FAB to make productive recommendations.

7.5. If it is not known at the time of the submission but later determined that the grant dollars available are capped, the budget will require additional FAB review. The investigator may request consideration for the use of internal PECARN resources to supplement the study budget. FAB will determine if internal resources are available and, along with the Executive Committee, will determine if and at what level internal resources can be allocated to the project.

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7.6. In addition to reviewing the budget, the committee will also assess and make recommendations regarding the general feasibility of the project.

8. Subcommittee Process for Review of Preliminary Budget:8.1. The subcommittee will review the preliminary budget at a breakout session during a PECARN

Steering Committee meeting. Prior to the meeting, the chair will assign a primary and secondary reviewer and a representative from the CDMCC to review the budget for all projects. The reviewers will prepare written reports. At the time of the subcommittee meeting, the study PI will be available to answer questions. This question-and-answer period will generally occur later in the meeting, and after the subcommittee has reviewed the preliminary budget. In case of a short turnaround RFA or as approved by the Executive Committee, the subcommittee may also convene an electronic review.

9. Format of Subcommittee Recommendations:9.1. The FAB subcommittee will review the preliminary budget and project feasibility and send their

written recommendations to the Research Node Center (RNC) Principal Investigators (PIs) and the Federal Program Officer. After consultation with the RNC PIs, the FAB subcommittee will send the final recommendations to the investigator electronically. This document will also detail specific action items and instructions/timeline for responding.

10. Budget Amendment and Resubmission to PECARN 10.1. The PI will work with the NA, assigned FAB member, and federal Program Officer to amend

the budget as needed. This will be an iterative process. Input from specific sites involved in the study should be solicited.

10.2. The amended budget will be resubmitted for review by FAB and the Steering Committee four weeks prior to the Steering Committee meeting.

10.3. PECARN will vote on the protocol at this Steering Committee meeting.

Schematics of Review Process:

After concept approval, investigator prepares the preliminary protocol and budget(along with NA and assigned FAB member)

▼Preliminary budget submitted to FAB and Steering Committee for review

4 weeks prior to SC meeting▼

FAB subcommittee recommendations sent to RNC PIs and Program Officer for review▼

After review by the RNC PIs, and Program Officer the FAB recommendations are provided to the investigator.

▼Iterative process between PI, nodal NA and FAB to amend budget and resubmit 4 weeks prior to Steering

Committee meeting for Steering Committee and FAB Review.▼

PECARN Steering Committee votes on protocol.▼

If endorsed, the protocol may be developed into grant application.(NA and FAB member will continue to work with PI during this process)

▼FAB reviews the grant budget and provides recommendations to RNC PIs

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After review by the RNC PIs, the FAB recommendations are provided to the investigator.▼

PECARN steering committee votes on the final grant submission

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Appendix 1 – Preliminary Budget TemplateThis spreadsheet may be used to develop your preliminary study budget and to compare your funding requirements to the fundingagency limits. This document can be used to determine if you need to request internal PECARN resources for your project. Columns 2, 3 & 4 are the actual support you expect to require and columns 5, 6 & 7 are support you wish to request from the PECARN infrastructure or hospital in-kind support. This document may be used for your initial FAB submission.

1 2 3 4 5 6 7 8

Description Total $ Amount

Percentage Support

Requested

Amount of Funding Required

Funding to be requested from

PECARN Infrastructure

Funding to be requested from

CDMCC Infrastructure

In-Kind Support from Particpating Institution

Funding Required less Infrastructure and In-Kind

Support Requested

PECARN Site Infrastructure

CDMCC Infrastructure

Hospital in-kind

Grant Needed

Primary Site Personnel Salary/Benefits % FTE AmountPrincipal Investigator 196,700$ 30% 59,010$ 40,000$ -$ 5,000$ 14,010$ Site Research Coordinator 40,000$ 100% 40,000$ 25,000$ -$ -$ 15,000$ Other persons 43,000$ 30% 12,900$ 12,900$ -$ -$ -$

Cost per Trip # Trips Amount Travel 1,350$ 6 8,100$ 5,000$ -$ -$ 3,100$

Other Expenses AmountExpense One 3,200$ 3,200$ -$ -$ -$ 3,200$ Expense Two 45,000$ 45,000$ -$ -$ -$ 45,000$ Expense Three 3,600$ 3,600$ -$ -$ -$ 3,600$

Primary Site Direct Cost 171,810$ 82,900$ -$ 5,000$ 83,910$

Site Personnel Salary/Benefits % FTE AmountSite Investigator 196,700$ 30% 59,010$ 10,000$ -$ 49,010$ Site Research Coordinator 40,000$ 100% 40,000$ 10,000$ -$ -$ 30,000$ Site Other persons 43,000$ 30% 12,900$ 5,000$ -$ -$ 7,900$

Cost per Trip # Trips AmountSite Travel 1,350$ 6 8,100$ 2,000$ -$ -$ 6,100$

Other Site Expenses AmountExpense One 3,200$ 3,200$ -$ -$ -$ 3,200$ Expense Two 45,000$ 45,000$ 15,000$ -$ -$ 30,000$ Expense Three 3,600$ 3,600$ 1,000$ -$ -$ 2,600$

Cost per Site 171,810$ 43,000$ -$ -$ 128,810$ Number of Sites 4

Total Site Direct Expenses 687,240$ 172,000$ -$ -$ 515,240$

CDMCC Personnel Salary/Benefits % FTE AmountCDMCC Investigator $196,700 10% 19,670$ -$ 19,300$ -$ 370$ CDMCC PhD Statistician $125,000 15% 18,750$ -$ 18,750$ -$ -$ CDMCC Program Manager $100,000 15% 15,000$ -$ 15,000$ -$ -$ CDMCC Study Coordinator $60,000 100% 60,000$ -$ 30,000$ -$ 30,000$ CDMCC Data Manager $70,000 100% 70,000$ -$ 35,000$ -$ 35,000$ CDMCC Master Statistician $75,000 50% 37,500$ -$ 20,000$ -$ 17,500$ CDMCC Other Persons $40,000 40% 16,000$ -$ 16,000$ -$ -$

Cost per Trip # Trips AmountCDMCC Travel 1,350$ 6 8,100$ -$ 8,100$ -$ -$

Other CDMCC Expenses AmountExpense One 3,200$ 3,200$ -$ 3,200$ -$ -$ Expense Two 45,000$ 45,000$ -$ 45,000$ -$ Expense Three 3,600$ 3,600$ -$ 3,600$ -$

Site Monitoring 50,000$ -$ -$ -$ 50,000$

CDMCC Direct Cost 346,820$ -$ 213,950$ -$ 132,870$

Total Project Direct Costs 1,205,870$ 254,900$ 213,950$ 5,000$ 732,020$

Project Research Budget

Preliminary Budget Planning Document (Updated May, 2009)

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STANDARD OPERATING POLICY AND PROCEDURE FOR INSTITUTIONAL REVIEW BOARD APPROVAL

1. POLICY

1.1 Obtaining Institutional Review Board (IRB) approvals for all research conducted by the investigative site is required by the Pediatric Emergency Care Applied Research Network (PECARN) before the site may begin a specific study.

1.2 Maintaining continuous IRB approval for each specific study throughout the study period is required.

1.3 The CDMCC must obtain and maintain documentation of continuous IRB approval for each specific study in order to collect data from the network sites.

1.4 Written documentation of original approval, all amendments and continuous IRB approval is required.

2. PURPOSE

2.1 Obtaining IRB approval for a proposed study at the investigative site is the first critical process in the protection of human subjects who volunteer to participate in clinical research.

2.2 This policy is intended to meet the requirements of federal regulations that all research involving human subjects be approved and reviewed at least annually by a qualified IRB.

2.3 It is the intent of PECARN to comply with federal regulations and guidelines and follow the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP).

3. SCOPE

This document describes the policy, procedures and responsibilities of PECARN members with regard to obtaining and maintaining continuous IRB approval throughout the duration of each specific research study. It applies to all PECARN investigators and designated staff with delegated applicable roles.

4. RESPONSIBILITY

4.1 Selection of a qualified IRB to review PECARN research protocols will be at the discretion of the Investigator based upon the site’s institutional requirements.

4.2 The investigator is responsible for assuring that the IRB reviewing each research study is in compliance with the relevant regulations, guidelines and requirements

4.3 The Investigator is responsible for submitting PECARN research protocols to the IRB within the time frame specified by the Steering Committee.

4.4 The Investigator is responsible for obtaining IRB approval for the protocol, amendments, advertisements and informed consent/assent/parental permission form(s) prior to enrolling patients or collecting data for the study.

4.5 The Investigator is responsible for submitting IRB renewal materials within the time frame required by the site’s IRB, in order to maintain continuous IRB approval for the study.

4.6 The Investigator is responsible for direct communications with the IRB and for informing the IRB of any protocol changes, deviations, violations, adverse events (AEs) or serious adverse events (SAEs).

4.7 The Investigator or documented designee is responsible for ensuring that copies of the IRB applications, IRB approvals of the protocol amendments, advertisements and consent/parental permission/assent form(s) are maintained in the site’s Essential Documents Binder (EDB). This includes documentation that all AEs and SAEs have been reported to the local IRB in accordance with study recommendations and local site requirements.

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4.8 The Investigator is responsible for sending to the CDMCC documentation of all IRB approvals (original approval, amendments and renewals). This may be done by electronic format or by fax or mail. Documentation consists of a letter from the IRB chair or minutes from the IRB meeting that formally document approval of the protocol or amendment.

4.9 The IRB is responsible for providing written documentation of review and approval of the protocol, advertisements, amendments, consent/assent/parental permission form(s) and for timely continuing review of the research and submitted AEs and SAEs.

4.10 The IRB is responsible for documenting that personnel involved in the study do not vote on the protocol.

5. PROCEDURES

5.1 Operations of a qualified IRB or ethics committee:5.1.1 An IRB is the board, committee or other group formally designated by an institution to review, to

approve the initiation of and to conduct periodic review of biomedical research involving human study subjects in order to assure the protection of the rights and welfare of human research volunteers.

5.1.2 IRB approval means that the IRB has reviewed the proposed clinical research study and it may be conducted at the investigative site within the constraints set forth by the IRB and by other institutional, local and federal regulations, requirements and guidelines.

5.1.3 Required membership of a qualified IRB consists of at least 5 members, both men and women of diverse backgrounds and expertise with at least 1 member having scientific expertise, 1 member who is not a scientist and 1 member who is not affiliated with the institution.

5.1.4 An IRB that regularly reviews research involving a vulnerable category of subjects (children, prisoners, pregnant women, handicapped or mentally disabled persons) must consider including one or more individuals who are knowledgeable about and experienced in working with such subjects. As PECARN is a pediatric network, it is preferable that each site’s IRB have pediatric expertise available when reviewing network protocols.

5.1.5 The IRB notifies the Investigator in writing of its decision to approve or disapprove the protocol or of modifications required to secure IRB approval. If the protocol is disapproved, the IRB provides a statement of the reasons for the decision and gives the investigator an opportunity to respond.

5.1.6 The IRB conducts continuing review of the protocol at intervals appropriate to the degree of risk, but not less than once a year.

5.1.7 An IRB expedited review may be carried out by the IRB Chairperson or one or more experienced reviewers designated by the IRB Chair from among the members of the IRB when appropriate

5.1.8 PECARN investigators or staff members who are members of the IRB will not review or vote on PECARN protocols (at their local site) in which they are involved. The site investigator will document this in writing as specified by the CDMCC.

5.1.9 IRB approval and renewal notices must include the title, version number and date of the protocol and any consent/assent/parental permission form(s). If the IRB does not provide the version number of the protocol in its written approval, the site must provide documentation (email acceptable) from the IRB chair or designate that specifies which version of the protocol was approved. A letter from the PI is not sufficient to confirm the version number.

5.2 Investigative site procedures:Note: Activities in this section may be delegated to other appropriate personnel, but ultimately remain the responsibility of the Investigator at the local site.

5.2.1 The Investigator submits the protocol, advertisements, amendments, informed consent/parental permission, assent form(s) and Investigator’s Brochure (as applicable), and any additional documents as may be required, to the IRB for review and approval prior to starting the study at the investigative site. The study materials should be submitted within the time frame determined by the principal investigator of the study.

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5.2.2 The Investigator maintains a copy of the complete initial IRB submission in the EDB. The investigator obtains a copy of all subsequent IRB approvals and maintains copies in the EDB.

5.2.3 The Investigator maintains copies of all correspondence with the IRB in the EDB. During the study, the Investigator informs the IRB of AEs, SAEs, changes to the conduct of the research, submits amendments, progress reports and any protocol deviations that occur at the investigative site.

5.2.4 The Investigator submits renewal applications to the IRB at periods specified by the IRB but not less than once a year. Timely submission of renewal requests is required in order to maintain continuous IRB approval. For example, IRB renewals may need to be submitted 2-3 months before IRB approval expires to ensure that the study does not lapse at the site.

5.2.5 The Investigator may be requested to provide additional material to the IRB for renewal such as a summary of adverse events or summarized patient accrual information. The CDMCC will provide this information upon request. The IRB will not be provided with blinded or unblinded outcome data, but for blinded studies, reports by the Data Safety and Monitoring Board (DSMB) will be provided, if requested.

5.2.6 Upon study conclusion, the Investigator prepares a final report for the IRB following the local IRB requirements.

5.3 Procedures for lapse of continuous IRB approval.There are two definitions for a lapse of continuous IRB approval. A discontinuity of documentation of continuous IRB approval at the CDMCC is considered a documentation lapse . A discontinuity of continuous IRB approval, as documented in the IRB approval and renewal dates, is considered an actual lapse of IRB approval . If the CDMCC does not receive documentation of IRB renewal of a continuously approved study by the date of expiration of the latest documented IRB approval, the site will be considered to have a documentation lapse.

5.3.1 The CDMCC will not accept data from an investigative site when a documentation lapse or an actual lapse has occurred. The CDMCC will notify the site Investigator and research assistants to cease patient enrollment until documentation of IRB approval is received by the CDMCC. The CDMCC will also inform the Research Node Center Principal Investigator and Nodal Administrator that there has been a documentation lapse at an investigative site in their Node.

5.3.2 Patient enrollment is not permitted during a documentation lapse, regardless of reason for the lapse.

5.3.3 Prior to resuming patient enrollment or data collection in a study, the Investigator must submit documentation of IRB renewal in writing to the CDMCC. Documentation should be the IRB minutes, or letter from the IRB indicating approval. If the formal IRB letter is not available, the site must send a letter or email from the IRB chair or IRB administrative staff that states that the protocol has been reviewed and approved. Upon receipt of appropriate documentation, the CDMCC will notify the site Investigator and research assistants that study participation may resume. The CDMCC will also inform the Research Node Center Principal Investigator and Nodal Administrator that the investigative site may resume participation in the study.

5.3.4 If there is an actual lapse of IRB approval between expiration and renewal, based on the dates of approval noted by the site IRB documentation, any and all patients who were inadvertently enrolled during that lapse will be removed from the study. The same pertains to any patients enrolled prior to IRB approval, Note that neither of the above situations should occur, because sites should cease patient enrollment if the CDMCC does not have documentation of IRB approval. For patients who were enrolled prior to the lapse of approval but had follow up or other data collected during the lapse, the local IRB will be notified. Unless the local IRB disagrees, follow-up data collected during the lapse will be used in the study.

5.3.5 CDMCC will notify sites regarding the status of studies after data collection and queries are complete. CDMCC will also notify sites when data analysis is complete. Each site IRB will determine the need for renewal from this point forward. Each site is responsible for sending documentation to the CDMCC of their renewal status for studies that have completed enrollment and data queries.

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6. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 50 Protection of Human Subjects21 CFR 56 Institutional Review Boards21 CFR 312.66 Assurance of IRB Review21 CFR 312.62 Investigator Recordkeeping and Record Retention21 CFR 812 - D IRB Review and Approval21 CFR 812.42 FDA and IRB Approval21 CFR 812.47 Emergency Research Under 50.24 of This Chapter45 CFR 46 Protection of Human Subjects45 CFR 46.107 IRB Membership45 CFR 46.109 IRB Review of ResearchICH E6, 2.0 The Principles of ICH GCPICH E6, 3.1.4 IRB/IEC ResponsibilitiesICH E6, 3.3 IRB/IEC ProceduresICH E6, 3.4 IRB/IEC RecordsICH E6, 4.10 Progress ReportsICH E6, 4.4 Communication with IRB/IECICH E6, 5.11 Confirmation of Review by IRB/IECHHS Guidance Guidance on 45 CFR 46.407 Review Process (Aug 2005)HHS FAQs FAQs on Human Research IRB Registration Process (Sep 2005)HHS FAQs FAQs on Human Research Regulations (Jan 2006)HHS FAQs FAQs on Research Involving Children (Jan 2006)

7. REFERENCES TO OTHER APPLICABLE SOPs

PECARN SOP&P: Adverse Event Recognition and ReportingPECARN SOP&P: Human Subject ProtectionPECARN SOP&P: Informed Consent Process

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STANDARD OPERATING POLICIES AND PROCEDURES FOR THE INFORMED CONSENT PROCESS

1. POLICY

1.1 Obtaining Institutional Review Board (IRB) approval for all Informed Consent (IC) documents, Parental Permission (PP) forms and pediatric Assent forms is required by the Pediatric Emergency Care Applied Research Network (PECARN) before the site may begin enrollment in a study to which these documents are applicable.

1.2 Maintaining continuous IRB approval for IC/PP/Assent documents throughout the duration of the study is required in order for the site to continue enrolling subjects.

1.3 Written documentation of original and continuous IRB approval is required. 1.4 PECARN studies will use written documentation of informed consent to obtain IC/PP/Assent (as

applicable) from all subjects in accordance with federal, state and local regulations, guidelines and IRB requirements, unless this requirement has been waived by the IRB.

1.6 Monitoring and/or auditing of PECARN investigative sites will include verification of written IC/PP/Assent (as applicable).

2. PURPOSE

2.1 Documentation of a clear and complete informed consent process is a critical step in the protection of human subjects who volunteer to participate in clinical research.

2.2 It is the intent of PECARN to comply with federal regulations and guidelines and follow the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP).

2.3.1 For applicable research protocols, this policy is intended to meet the requirement that all investigators involved in research on human subjects have obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

2.3.1 This policy is intended to meet the requirement that, when applicable, IC shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of the consent.

3. SCOPE

This document describes the policies, procedures and responsibilities of PECARN members with regard to obtaining and documenting written informed consent from each human subject, or the subject’s legally authorized representative, for all applicable PECARN protocols. It applies to all PECARN investigators and designated staff with delegated applicable roles. Please note that certain PECARN studies will not require written informed consent, as determined by the local IRBs. This document does not pertain to these studies.

4. RESPONSIBILITY

4.11 The Investigator is responsible for submitting IC/PP/Assent documents to the IRB and obtaining IRB approval for these documents, when applicable, prior to consenting or enrolling any subjects.

4.12 The investigator or an appropriately trained associate or staff member is responsible for obtaining informed consent on all research subjects, with the understanding that the ultimate responsibility of insuring adequate consent lies with the site investigator.

4.13 The IRB is responsible for providing written confirmation of approval of IC/PP/Assent documents submitted by the investigator and designating the version or version date of the approved document/s.

4.14 The Investigator is responsible for ensuring that IC/PP/Assent is obtained from each subject, or the subject’s legally authorized representative, as necessary, for each applicable PECARN protocol, using the most recent IRB-approved version of these documents.

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4.15 The Investigator is responsible for assuring that all elements of IC are discussed with the subject or the subject’s legally authorized representative in terms that are understandable, answering any questions and allowing sufficient time for considering participation.

4.16 The Investigator is responsible for assuring documentation of the informed consent process and maintaining the original, signed copies of all IC/PP/Assent forms in the subject’s study file, or the site’s Essential Documents Binder (EDB) or a reasonable alternate location that is specified and documented in the EDB. A selected alternate location must provide easy access for a site monitor or auditor.

4.17 The Investigator or an appropriately trained associate or staff member is responsible for ensuring that each subject or legally authorized representative receives a copy of the applicable IC/PP/Assent form/s. Again, the ultimate responsibility for insuring that this occurs rests with the site investigator.

4.18 The investigator is responsible for ensuring that time of consent is documented in some location other than the consent form (e.g., an investigator note to file), when applicable as determined by the investigator or CDMCC.

4.19 The Investigator is responsible for ensuring and documenting that no study procedures or interventions are performed on a subject prior to obtaining IC/PP/Assent (as appropriate).

5. PROCEDURES

5.4 Procedures for Standard Written Informed Consent:

5.4.1 The Investigator submits IC/PP/Assent forms (as appropriate) to the IRB for review and approval prior to use.

5.4.2 When a template is provided, the Investigator and/or Research Associate (RA) reviews and revises it to ensure that it contains all required elements and any additional elements required by state or local authorities and the investigative site’s IRB.

5.4.3 Each IRB-approved IC/PP/Assent form will have an approval date or version date to ensure that the most current form is used.

5.4.4 The Investigator or RA discusses all elements of the IC/PP/Assent form/s with the potential subject or legally authorized representative in lay language that promotes understanding. Note: If the subject and/or legally authorized representative speak a language other than English, a certified translation of the IC/PP/Assent forms in the subject’s native language with documented IRB approval must be used and must meet all of the requirements listed above for the English documents.

5.4.5 The potential study subject or legally authorized representative should be given as much time as s/he deems necessary to read the consent document, consider study participation and have questions answered prior to signing the IC/PP/Assent form. Note: Determining that research subjects and/or parents understand the information presented is part of the IC process. The presenter should ask questions in an attempt to validate that there has been understanding.

5.4.6 The subject and/or legally authorized representative must sign and date the appropriate IC/PP/Assent document prior to the performance of any study-related procedures in compliance with the each site’s IRB requirements. Note: If in the course of routine medical care, certain examinations, procedures or tests were performed that could be used to assess eligibility, these assessments, done prior to the informed consent process, would not be considered study procedures even though the results could be used for the study (if allowed by the protocol and the IRB).

5.4.7 The person presenting the IC/PP/Assent for each subject should also sign and date the appropriate documents at the time consent is obtained from the subject or legally authorized representative.

5.4.8 Additional signatures must be obtained (for example signatures from a witness, witnesses or both parents) if required based on sponsor, institutional, IRB or other applicable requirements.

5.4.9 The study individual performing the consent process must ensure and documents that the subject or legally authorized representative has received a copy of the appropriate IC/PP/Assent form/s as specified by the site IRB.

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5.4.10 The Investigator ensures that all active study subjects and/or legally authorized representatives are provided with updated study information as soon as possible and sign IRB-approved amended IC/PP/Assent forms, when necessary, retaining the original and providing a copy to the subject or legally authorized representative.

5.5 Procedures for Alternative Written Informed Consent:

5.5.1 In certain circumstances, IC may be obtained in an alternative manner to that described above. In an effort to standardize study activities throughout PECARN, alternatives may be suggested when appropriate, but the Investigator and the local IRB must determine if this is allowable.

5.5.2 An IRB may, for some or all study subjects in a given study, waive the requirement that the study subject and/or legally authorized representative to sign a written IC/Assent form in accordance with federal regulations as delineated in 45 CFR 46.

5.5.3 When the standard written IC cannot be obtained, the IRB may permit a written summary document that embodies the elements of informed consent to be read to the study subject or legally authorized representative. The oral presentation must be witnessed and the IRB must approve the written summary and/or oral presentation. A “short form” stating that the elements of IC have been presented orally to the subject, must be signed by the study subject or legally authorized representative. The witness and the Investigator (or presenter) must also sign the short form and the summary. Copies must then be provided to the subject or legally authorized representative.

5.3 Procedure for Obtaining Assent

5.3.1 Assent is required in writing for all subjects ≥ 7 years old. Note: ”Asking a child for a decision, then disregarding that decision if it conflicts with what the Investigator or parent/guardians wish, is not acceptable” (SACHRP 11/1/05).

5.3.2 If assent is not obtained, the subject may participate in the study only if the following 3 conditions are met and documented: The study offers potential direct benefit to the child; Treatment is available only in the context of the research project; and The child is not considered mature enough to act in his/her own best interests.

5.4.3 The age, maturity and psychological state of the child should be taken into account when determining whether children are capable of assenting.

5.4.4 If verbal assent is obtained from a child younger than 7 years of age, this should be documented and should state the information provided to which the child verbally agrees.

6. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 50 Protection of Human Subjects21 CFR 50.20 General Requirements for Informed Consent21 CFR 50.27 Documentation of Informed Consent21 CFR 56 Institutional Review Boards21 CFR 312.62 Investigator Recordkeeping and Record Retention21 CFR 312.66 Assurance of IRB Review21 CFR 812 – D IRB Review and Approval21 CFR 812.42 FDA and IRB Approval21 CFR 812.47 Emergency Research Under 50.24 of This Chapter45 CFR 46 Protection of Human Subjects45 CFR 46 - D Additional Protections for Children Involved as Subjects in Research45 CFR 46.116 General Requirements for Informed Consent45 CFR 46.117 Documentation of Informed Consent45 CFR 46.408 Requirements for Permission by Parents or Guardians and for Assent by

ChildrenICH E6, 4.8 Informed Consent of Trial Subjects

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ICH E6, 5.11 Confirmation of Review by IRB/IECICH E6, 5.18 MonitoringICH E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationHHS FAQs FAQs on Research Involving Children (Jan 2006)

7. REFERENCES TO OTHER APPLICABLE SOPs

PECARN SOP&P: Human Subject ProtectionPECARN SOP&P: Institutional Review Board ApprovalPECARN SOP&P: Site Monitoring

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STANDARD OPERATING POLICY AND PROCEDURE FOR ADVERSE EVENT RECOGNITION AND REPORTING

INTERVENTION CLINICAL TRIALS

1. POLICY

Good Clinical Practice requires the investigation and reporting of adverse events that occur during the conduct of a clinical study. Such reporting requirements place different responsibilities on the clinical investigator, the Institutional Review Board (IRB) and the Study Principal Investigator. An adverse event (AE) can be broadly defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or device, whether or not considered related to the medicinal product or device. The Study Principal Investigator and all other participating Investigators and their key study personnel must be familiar with protocol-defined adverse events for products under investigation or for procedures being performed. All participating Investigators and key study personnel must be familiar with the natural history of the disease or disorder being treated, the parameters to judge that a therapy is successful, and the parameters to judge that a therapy is not successful. Any new or worsening sign or symptom that may be attributable to the investigational product or to the subject’s involvement in the study must be recognized, documented and reported according to applicable regulations and guidelines. Prompt reporting of serious and unexpected AE that occur during an interventional clinical study is a major health and safety priority.

2. SCOPE

This SOP defines the responsibilities of PECARN members with regard to the managing and reporting of adverse events occurring in PECARN interventional clinical trials in order to ensure compliance with applicable adverse event reporting requirements and to provide uniformity in the management of adverse events.

It is the intent of PECARN to follow the ICH Guidelines for the management and reporting of adverse events.

This SOP applies to all investigators and research assistants and others involved in PECARN clinical research.

This SOP is to apply to all interventional clinical research performed in the PECARN network.

If the CDMCC is not the data center for a particular protocol, the applicable data center would be expected to comply with the PECARN SOPs.

3. RESPONSIBILITY

The study principal investigator is responsible for ensuring that a Data and Safety Monitoring Plan is written in the study protocol. This plan will include, among other things, the mechanism for assessing and reporting adverse event.

All participating Investigators are responsible for recognizing and reporting all serious adverse events or experiences (SAE) and any other expected, unexpected and non-serious or routine AE, according to applicable regulations and guidelines and the requirements of the protocol.

All participating Investigators are responsible for the appropriate medical management and follow-up of subjects who have experienced an AE while on study, irrespective of relationship to study treatment or investigational product.

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All participating Investigators or their designees are responsible for documenting AEs as described in the study protocol.

The Study Principal Investigator is responsible for expedited reporting to appropriate regulatory authorities if required.

The Study Principal Investigator is responsible for clearly describing the plan for reporting of AE and SAE in the study protocol in compliance with all applicable regulations.

If DSMB oversight is specified in the protocol Data and Safety monitoring plan, the CDMCC is responsible for collecting data for evaluation by the DSMB unless another data center is designated.

The CDMCC is responsible for forwarding applicable Safety Reports to participating Investigators. The participating Investigators are responsible for forwarding Safety Reports to the IRB(s) of record. The DSMB is responsible for preparing Safety Reports or other appropriate notifications as a result of SAEs that are reported to the CDMCC.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.32 IND Safety Reports21 CFR 312.50 General Responsibility of SponsorsICH E6 Good Clinical Practice: Consolidated GuidanceICH E2A Clinical Safety Data Management: Definitions and Standards for

Expedited Reporting (March 1995)

5. REFERENCES TO OTHER APPLICABLE SOPS (TBD)

6. TERMINOLOGY

Adverse Event (AE): Any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational drug product or device whether or not considered related to the investigational drug or device.

Data and Safety Monitoring Board (DSMB): An independent data monitoring committee that may be established by PECARN to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to PECARN whether to continue, modify, or stop a trial.

Disability: Substantial disruption of a person’s ability to conduct normal life functions.

Investigator: A person responsible for the conduct of the clinical trial at a PECARN site. If a trial is conducted by a team of individuals at a trial site (i.e. the Emergency Medicine staff of a hospital), the investigator is the responsible leader of the team.

Study Principal Investigator: The Investigator that initiates the research protocol within the network.

Serious Adverse Event (SAE): Any untoward medical occurrence that: results in death is life-threatening requires inpatient hospitalization (exceeding 24 hours) or prolongation of existing hospitalization results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect

A SAE may occur in other situations that may not be immediately life-threatening or result in death

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or hospitalization, but which may jeopardize the patient or require intervention to prevent one of the above outcomes. These should also usually be considered serious.

Unexpected Adverse Event: An adverse event, the nature or severity of which is not consistent with the applicable product information supplied by the drug manufacturer or as defined in the protocol

7. ATTACHMENT

A. Adverse Event Reporting Terminology

8. SPECIFIC PROCEDURES

A. Identifying Adverse Events at the Clinical Site

Who Task Attachment Applicable Policies/SOP

Study Principal Investigator

In writing the clinical protocol, include instructions for recognizing, investigating and reporting anticipated/unanticipated AE throughout the study period and the protocol-defined follow-up period, including criteria for identifying SAE

Adverse Event Reporting Terminology

Study Principal Investigator

Ensure the approved case report form (CRF) captures relevant information for all serious and non-serious AE1

CDMCC/Study PI

Provide all Investigators with adequate AE training and protocol-specific reporting training at the request of the Investigator.

Note: 1This should include: onset date, etiology (known or suspected), nature of the event, severity and duration of the event, and relationship of the event to the investigational product.

B. Clinical Management and Documentation of Adverse Events

Who Task Attachment Applicable Policies/SOP

CDMCC/Study PI

Train Investigators and research assistants on the recognition, handling, recording and reporting of adverse events, including regulations and reporting timeframes1at the request of Investigator

Study Principal Investigator

Provide instructions for AE follow up and assessment in the protocol2

Study PI/CDMCC

Provide instructions for breaking the study blind (if necessary for the immediate medical care of an AE) in the protocol

RA/Monitor Verify that copies of adverse event reporting forms are filed in the site’s Study File and entered into CDMCC databases when appropriate

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RA/Monitor Verify that Investigator/research assistant has kept originals or photocopies of all relevant AE docu-mentation in the subject’s file

RA/Monitor Verify that Investigator has file copies of all correspondence with the IRB in the site Study File

Note: 1During the protocol specified AE follow up period, the following should be investigated: spontaneous reports by subjects, observations by key study personnel, reports to study staff by the subject’s family or medical care providers, possible AE documented in medical records, progress notes, etc., 2This may include: directed or complete physical examination and clinical assessment; appropriate laboratory tests, diagnostic procedures and/or studies; and arrange medical/surgical consultation as needed.

C. General Procedures for Adverse Events

Who Task Attachment Applicable Policies/SOP

Study Principal Investigator In the protocol, require Investigators to report

any serious and unexpected (unanticipated) adverse experiences, whether or not they are considered related to the investigational product.

Provide procedures and forms for AE/SAE reporting in the protocol

CDMCC/HEDA PI/Study PI

Determine training needs for site Investigators, RA and other personnel involved in the study.Promptly examine all information provided by Investigators to confirm the Investigator’s find-ings regarding the cause of the SAE, and to de-termine the likelihood of reoccurrence

CDMCC Receive and maintain all Adverse Event data provided by sites

CDMCC Provide the DSMB with all necessary AE/SAE data

CDMCC Prepare and distribute appropriate notifications of the SAE to all participating Investigators

CDMCC Prepare and distribute Safety Reports provided by the DSMB

DSMB Determine if a reported SAE represents an unreasonable risk to study subjects

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DSMB Determine if any corrective actions should be initiated as a result of any known specific or collective SAE/AE(s) and inform all participating Investigators of the corrective action (e.g., revision of informed consent form, protocol, CRF)If the reported adverse event represents an unreasonable risk to study subjects, begin steps to terminate the study (the entire study or relevant portions) within 5 days of that determination, but no more than 15 days after learning of the event

CDMCC Prepare Safety Reports for distribution to Investigators when necessary

HEDA Investigator/RA Notify the CDMCC if the IRB requires revisions to the informed consent form or other measures based on its review of the Safety Reports

HEDA/Investigator/RA Notify the IRB of all protocol modifications or termination

Monitor During routine monitoring visits, verify that the Investigator has reported all SAE to the IRB within the required timeframe and has submit-ted all Safety Reports or other appropriate noti-fications received from the CDMCC

Monitor Confirm that the Investigator has reported all routine AE as part of the periodic or annual reporting requirements to the IRB(s) of record

Note:

Appendix A: Adverse Event Reporting Terminology

1. SeveritySeverity rating of the AE may not necessarily correspond with the participant’s experience of them.

Ratings depend upon the intervention taken to alleviate symptoms and the level to which symptoms interfere with usual activities.

Mild: Participant is aware of the signs or symptom(s) and/or event(s), but they are easily tolerated and require no intervention.

Moderate: Participant’s normal routine is affected by one or more signs or symptoms. Discomfort is enough to interfere with usual activities and possible need for intervention. For example, the participant rested in bed, went to the doctor, left work/school early, etc.

Severe: Symptoms are incapacitating, affecting the participant’s ability to perform usual activities, significantly affecting clinical status, and there is a definite need for clinical intervention. Participant feels symptom is sufficiently severe that it cannot be tolerated. For example, participant will drop out of the study if symptoms persist.

Life Threatening: Immediate risk of death. If there is any doubt as to whether or not a symptom is life threatening, consult with a physician immediately.

2. Outcome:

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Do not specify the outcome of the AE until the AE ends or the participant completes or leaves the study (whichever comes first).

Possible outcomes are:Resolved, no sequelaeNot yet resolvedResulted in chronic condition or disabilityDeceasedUnknown

3 Attribution/Association with the Protocol or Intervention: An assessment of the relationship between the adverse event and the research intervention

Adverse event definitely associated with a research intervention: An adverse event, which has a timely relationship to the occurrence of the research intervention, follows a known pattern of response, for which no alternative cause is present.

Adverse event probably associated with a research intervention: An adverse event, which has a timely relationship to the research intervention, follows a known pattern of response, but for which a potential alternative cause may be present.

Adverse event possibly associated with a research intervention: An adverse event, which has a timely relationship to the research intervention, follows no known pattern of response, but a potential alternative cause does not exist.

Adverse event unrelated to a research intervention: An adverse event, for which there is evidence that it is definitely related to a cause other than the research intervention, or if there is a timely relationship, the event does not follow a known pattern of response, and there is an alternative cause.

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STANDARD OPERATING POLICY AND PROCEDURE FORSITE MONITORING IN PECARN RESEARCH STUDIES

1. SITE MONITORING POLICY OVERVIEW

Site monitoring is an important aspect of a clinical study, whether a double blind randomized drug trial or an observational investigation. The overall objectives of Site Monitoring are to:

Verify that the site is correctly following the study protocol. Verify that all regulatory documents exist and are current Document and report on clinical study progress Document that the protocol and other items are current and IRB approved Update the site team of any changes in study conduct/documentation Ensure that Sponsor requirements and Investigator obligations are met Ensure continued acceptability of the Site Investigator, team and facility Obtain and review current clinical data, reports and source documents Ensure adequate investigational product inventory and accountability Assure compliance with Good Clinical Practice Assure patient safety Assure data quality

Site monitoring generally consists of an on-site meeting of the Monitor, the HEDA Investigator and his/her research staff. Certain aspects of monitoring may also be conducted via phone and mail or electronic communication when travel to the site is impractical. Monitoring visits may occur during several phases of the study. A Site Initiation Visit is conducted prior to the start of a study, one or more ongoing Monitoring Visits may be conducted during the study, and a Close Out Visit usually occurs after the study termination. Additionally, sites may get follow up visits as needed based on the study protocol, the site’s progress and if determined by the regional node center, CDMCC, or PECARN steering committee.

The type of study being conducted will affect the monitoring plan. Retrospective studies and/or chart abstraction studies may require minimal monitoring, but at least one site visit is likely to be necessary and reduces the chances of poor quality patient recruitment or data abstraction. Observational studies will generally require a higher level of monitoring than retrospective studies, and clinical trials or other interventional studies will require a specific site-monitoring schedule. Size of the study, number of subjects, study population characteristics and other aspects of the study protocol should be considered when devising a monitoring plan.

2. SCOPE

This policy applies to research conducted within the PECARN network.

3. RESPONSIBILITY

The Study PI is ultimately responsible for the quality of a study and budgeting for implementation of Site Monitoring. The study budget will have to be approved by the Budget and Feasibility Committee prior to PECARN approval.

Each of the PECARN subcommittees will review the monitoring plan for the study as needed. The safety and regulatory subcommittee and quality assurance subcommittee will conduct a detailed review of the monitoring plans in each protocol before study implementation.

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Implementation

The Study Investigator is responsible for including a general study monitoring plan in the study protocol that describes the major aspects of how the study will be monitored. A supplemental study-specific monitoring plan must be drafted prior to the start of the study that outlines specific criteria for site monitoring. This plan may include the number of planned site visits, criteria for focused visits, or additional visits, a plan for chart review, a follow up plan for non compliant sites etc. If there is no plan for site monitoring, the Investigator must address the reasons why monitoring is not needed. In nearly all PECARN studies, site monitoring should be anticipated by the investigator.

The HEDA Site Investigator is responsible for ensuring an adequate response to all site monitoring findings and rectifying all protocol deviations or other issues identified on the monitoring report.

The nodal administrator and CDMCC project manager are responsible for ensuring that each site is visited according to the monitoring plan. The Site Monitor is responsible for reporting the results of the visit to the site PI and the CDMCC.

During the PECARN quarterly meetings, the Safety and Regulatory and Quality Assurance subcommittees will review monitoring reports or summaries of the reports compiled by the CDMCC. Reports will be submitted as requested, to the SRA committee prior to the quarterly meeting in order to both educate SRAS regarding ongoing safety and regulatory challenges occurring in PECARN and to help identify trends needing intervention. In addition, with serious infractions at the discretion of the CDMCC, ad hoc reports would be sent to the SRAS. These PECARN subcommittees will make recommendations to the steering committee if needed. The PECARN steering committee will vote on any recommendations of these subcommittees

For serious infractions of the protocol, patient safety or other serious concerns, the site monitor could make immediate recommendations to head of the CDMCC and the study PI about probationary enrollment suspension at the site in question. The ultimate decision about suspension would be determined by the CDMCC PI and Study PI.

The CDMCC will maintain records of all site monitoring reports. The CDMCC will provide advice on site monitoring and will assist nodal administrators and monitors in conducting and coordinating site visits when necessary.

The Monitor is responsible for conducting the monitoring visit at the clinical site(s) and completing a CDMCC formatted report and letter to the Site Investigator summarizing the findings. The Monitor and Investigator are responsible for following up with non-compliant sites and decisions regarding on going visits. If monitoring visits reveal serious protocol deviations that have not been rectified by the HEDA after the site visit, the CDMCC will make a recommendation to the Investigator, the project working group, and the Steering Committee regarding site termination.

4. APPLICABLE REGULATIONS AND GUIDELINES

ICH E6, 2.0 The Principles of ICH GCPICH E6 Good Clinical Practice: Consolidated GuidanceICH E6, 4.5 Compliance with Protocol ICH E6, 5.3 Medical ExpertiseICH E6, 5.5 Trial Management, Data Handling and Record KeepingICH E6, 5.7 Allocation of Responsibilities

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ICH E6, 5.15 Record Access45 CFR Part 46 Protection of Human Subjects21 CFR Part 50 Protection of Human Subjects (FDA trials)ICH E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationICH E6, 5.23 Multicenter Trials FDA Guideline The Monitoring of Clinical Investigations (January 1988)

See also: The Nuremberg Code (1949) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of

Research The World Medical Association Declaration of Helsinki (last revision 2002)

5. SPECIFIC PROCEDURES

A. Study Protocol Development

The Investigator will include a description of the plan for site monitoring in the study protocol/monitoring plan or must address the reasons why site monitoring is not required. The monitoring plan must include (but is not limited to) the frequency and type of monitoring (Site initiation, ongoing, site close out) that will be required. It is generally recommended that all sites receive a monitoring visit. However, if specific sites are to be visited, the plan must address how sites will be selected for visitation. The study plan must comply with Good Clinical Practice guidelines and any applicable federal regulations.

B. Evaluation of Monitoring Plan

The PECARN Subcommittees and CDMCC will assess the site monitoring plan based on several factors: study design complexity, phase of development, Investigator’s experience, previous site compliance, rate of subject enrollment, site experience, study type, regulatory issues and any other unique attributes of the study and the site. The investigator, with help from the CDMCC will estimate the number of anticipated monitoring visits based on study complexity, length of study, and other factors. The investigator must follow the recommendations of the PECARN Steering Committee (which will be based on subcommittee and CDMCC recommendations). C. Budgeting for Site Monitoring

If the project is externally funded, the investigator is required to obtain funding to support monitoring visits. Site monitoring costs should be included in the study budget, following the CDMCC site monitoring guidelines, taking into account any available CDMCC resources dedicated for site monitoring. Any funding issues should be addressed with the nodal administrators or PECARN subcommittees. If the CDMCC is expected to fund site monitoring visits, the investigator must obtain approval from the CDMCC program manager or principal investigator before the protocol will be approved by the Steering Committee.

D. Implementation of the Monitoring Plan

The CDMCC will work with the Investigator regarding scheduling and conducting monitoring visits. The CDMCC will implement a monitoring plan with the Nodal Administrators or other identified qualified Study Monitors. The CDMCC will also provide a report to the investigator summarizing the Monitor’s findings.

E. Responding to Monitoring Reports and Documenting Appropriate Response.

The site investigator is responsible for responding to and rectifying any issues identified as follow up

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items. All items identified in the report must be corrected to the satisfaction of the CDMCC and the Study Investigator. Failure to resolve crucial issues will be reported to the study Principal Investigator, the project working group, and the Steering Committee, who will consider HEDA suspension from the study until resolution is accomplished.

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STANDARD OPERATING POLICY AND PROCEDURE FOR ARCHIVING STUDY RECORDS

1. POLICY

1.1. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. This is required for all applicable studies conducted by the Pediatric Emergency Applied Research Network.

1.2. The investigator will save all documents in a study as specified in the study protocol, or by federal regulations.

2. PURPOSE

2.1. This document describes the policy, procedures and responsibilities of PECARN members with regard to archiving study records for each specific applicable research study.

3. SCOPE

3.1. This SOP applies to all PECARN investigators and designated staff with delegated applicable roles. The SOP applies to clinical trials and research studies conducted in the network.

4. DEFINITIONS

4.1. The HEDA investigator is the investigator who is responsible overall for the site’s participation in the PECARN.

4.2. The lead investigator-the investigator who received official Steering Committee approval to conduct the study and who provides leadership of the conduct of the study.

4.3. The site investigator-the investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN or PECARN related site.

4.4. The HEDA investigator-the investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

5. RESPONSIBILITY5.1. The site investigator is responsible for maintaining applicable case history records, the study

protocol and related documentation, including IRB documents after the conclusion of the study.

6. PROCEDURES6.1. There are two types of records that are kept regarding a clinical investigation: (1) case history

records and (2) the study protocol and related documentation, including IRB documents. Case history records include both data collection forms and documents that support data in those forms and should contain: (1) basic subject identification information; (2) information showing that each subject meets the inclusion criteria or justification for enrolling the subject; (3) sufficient information to support data in the case report form as submitted to the sponsor; (4) information on each subject’s exposure to the test or control article, including the date (and time, if relevant) of each administration and the quantity administered; (5) copies of case report forms submitted to the sponsor if required; (6) signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the

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nurses’ notes as applicable. Case history records should be retrievable in such a fashion that all information regarding each individual in a study is attributable to that individual.Case history records also include information obtained from tests and examinations, such as physical examinations; lab results; ex-rays; progress notes; consultations; correspondence; information and data on the subject’s condition before, during, and after the clinical investigation; all diagnostic tests results; diagnoses made, concomitant or concurrent therapy; and factors that might alter the test article’s effects (e.g., development of an intercurrent illness). [FDA Information Sheets] [21 CFR 312.62(b)]

6.2. The site and lead investigator must maintain all applicable study records in accordance with federal guidelines, protocol requirements and the investigative site requirements.

6.3. For federally funded studies subject to the Common Rule, records relating to the research conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the regulatory authorities at reasonable times and in a reasonable manner. [45 CFR 46.115(b)] [ICH E6 (3.4)]

6.4. For studies that involve an IND or FDA-regulated product, an investigator shall retain records for a period 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. [21 CFR 312.62(c)]

6.5. These documents should be retained for a longer period, however, if required by the applicable regulatory authorities or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained. [ICH E6 (4.9.5)]

7. APPLICABLE REGULATIONS

21 CFR 312.57 Recordkeeping and Record Retention21 CFR 312.58 Inspection of Sponsor’s Records and Reports21 CFR 312.62 Investigator Recordkeeping and Record Retention 21 CFR 312.68 Inspection of Investigator's Records and Reports 21 CFR 812.140 Records 21 CFR 812.145 Inspections ICH E6, 2.10, 2.11 The Principles of ICH GCP ICH E6, 4.9 Records and ReportsICH E6, 5.5 Trial Management, Data Handling, and Record Keeping ICH E6, 5.15 Record AccessICH E6, 8.0 Essential Documents for the Conduct of a Clinical Trial

8. REFERENCES TO OTHER APPLICABLE SOPs

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STANDARD OPERATING POLICY AND PROCEDURE FOR FINANCIAL CONFLICT OF INTEREST

1. POLICY

1.1. There are a number of conflicts of interest which may arise during the course of a research study. Disclosure, certification and management of financial conflicts of interests will be addressed in this standard operating procedure.

1.2. Failure to comply with these fundamental ethical obligations jeopardizes the validity of the entire research program and puts the trustworthiness of the data derived in question.

1.3. Financial conflict of interest oversight is not required for all studies. For instance, a chart abstraction study may not require financial conflict of interest management.

1.4. When a sponsor outside PECARN implements a protocol at PECARN sites, the sponsor will manage the financial conflict of interest.

1.5. Those studies which require financial conflict of interest oversight by PECARN will be identified by the PECARN steering committee at the time of final protocol approval. If conflict of interest oversight is required, the steering committee will identify interested parties. Interested parties are individuals or groups which stand to gain or lose from the results of the research. An example of an interested party would be a drug manufacturer that stands to expand their market based on results of and investigator initiated IND study.

1.6. The following may cause a financial conflict of interest:

1.6.1. Any compensation that is affected by the outcome of clinical studies1.6.2. Any equity or ownership interest in an interested party that is not publicly traded or

whose value cannot be readily determined, including, but not limited to stock options or royalty payments

1.6.3. Any equity or ownership interest in excess of $50,000 in an interested party that is publicly traded

1.6.4. Any proprietary interest in the investigational product (e.g., patent, trademark, copyright or licensing agreement

1.6.5. Any significant payments of a cumulative value of $25,000 from the interested party to the Investigator or institution for a covered study, in excess of the actual costs of conducting the clinical study, and including but not limited to grants, equipment, consultation fees and honoraria.

1.7. FDA regulations and guidance provide detailed instructions about required financial disclosure. This policy is intended to meet the requirements of federal regulations that all research involving human subjects.

1.8. Any investigator participating in a PECARN study must also be aware of conflicts within the network. An Investigator who sits on a PECARN subcommittee and submits a proposal to that subcommittee must recuse themselves from voting on the proposal.

2. PURPOSE2.1. It is the intent of PECARN to comply with federal regulations and guidelines and follow the

International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP).

3. SCOPE

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3.1. This procedure applies to any PECARN Investigators (Principal Investigators, Co-investigators, Sub-investigators), who are participating in a PECARN clinical study. This also applies to the PECARN investigator’s spouse and dependent children.

4. DEFINITIONS4.1. PECARN Investigators-Investigators approved by PECARN steering committee to conduct

PECARN related research activities. 4.2. The HEDA investigator-the investigator who is responsible overall for the site’s participation in

the PECARN.4.3. The lead investigator-the investigator who received official Steering Committee approval to

conduct the study and who provides leadership of the conduct of the study.

4.4. The site investigator-the investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN or PECARN related site.

4.5. The HEDA investigator-is the investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

5. RESPONSIBILITY5.1. The Central Data Management Coordinating Center (CDMCC) is responsible for obtaining and

storing the certifications and disclosures from PECARN Investigators.

5.2. All PECARN Investigators are responsible for complying with regulations and institutional requirements governing disclosure of financial interests in a clinical study that may impact upon its conduct, evaluation or outcome.

6. PROCEDURES6.1. The following procedures are required for those studies identified by the steering committee to

require financial conflict of interest oversight: 6.2. PECARN Investigators are required to submit either a certification (FDA form 3454) that a

conflict does not exist, or a disclosure (FDA form 3455) of the financial conflict of interest. 6.3. Certifications and Disclosures will be submitted by the investigator on an annual basis. 6.4. Failure to provide certification or disclosure at required deadlines will result in a halt in study

enrollment.6.5. Financial conflicts of interest are to be disclosed to the appropriate local review bodies (e.g.

Conflict of Interest Committees, IRB), and if specified, to potential research subjects. 6.6. In addition, disclosure or certification will be provided to the CDMCC to track and house. For

disclosures, the management plan approved by the local review body will also be provided to CDMCC.

6.7. PECARN investigators will also maintain documentation on site.

7. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 54 Financial Disclosure by Clinical Investigators21 CFR 312.53 Selecting Investigators and Monitors21 CFR 812.43 Selecting Investigators and MonitorsICH E6, 5.8 Compensation of Subjects and Investigators ICH E6, 5.9 FinancingDHHS Final Guidance Document: Financial Relationships and Interests in Research

involving Human Subjects: Guidance for Human Subject Protection (May 5, 2004)

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8. REFERENCES TO OTHER APPLICABLE SOPs

8.1. IRB SOP8.2. Protocol development SOP

9. ATTACHMENTS

A. Form FDA 3454, Certification: Financial Interests and Arrangements of Clinical InvestigatorsB. Form FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators

Attachment GA 104-A

FORM FDA 3454

To retrieve Form FDA 3454 go to FDA Forms Distribution Page for CDER at the following URL:

http://www.fda.gov/opacom/morechoices/fdaforms/cder.html

Follow directions on the web site page for downloading this form, or make a copy of the form provided as an attachment in the SOP printed document.

Attachment GA 104-B

FORM FDA 3455

To retrieve Form FDA 3455 go to FDA Forms Distribution Page for CDER at the following URL:

http://www.fda.gov/opacom/morechoices/fdaforms/cder.html

Follow directions on the web site page for downloading this form, or make a copy of the form provided as an attachment in the SOP printed document.

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STANDARD OPERATING POLICY AND PROCEDURE INFORMATION SYSTEMS AND DATA MANAGEMENT

ACCESS CONTROL

1. POLICY

1.1. Security controls or methods that allow access to PECARN information systems must include, at a minimum:

1.1.1. Unique user identifiers that enable persons to be uniquely identified. 1.1.2. A secret identifier (at minimum, a password).

1.2. Appropriate access controls should be granted to ensure that study members can perform their necessary tasks without compromising the security of research data.

1.3. Group logins must not be used to gain access to PECARN information systems containing confidential information. Group logins may be used when accessing systems that do NOT include confidential information.

1.4. PECARN staff must not share or reveal their login, password, to others.1.5. PECARN staff must adhere to local policies regarding access to data, keeping data, copying data, and

printouts in secure locations, periodically changing passwords and ensuring workstation is not accessible to authorized persons.

1.6. PECARN members and staff are entirely responsible or any and all activities that occur under their account.

1.7. PECARN staff must notify the CDMCC immediately of any unauthorized use or any other breach of security.

1.8. Confidential data may not be downloaded to individual laptops or home computers. 1.9. E-mail systems are not secure and confidential data should be shared using a secure manner of

communication.

2. PURPOSE2.1. To ensure PECARN information systems have appropriate access controls to prevent unauthorized use or

disclosure of confidential information.

3. SCOPE3.1. This policy applies to all information systems related to PECARN research activities.

4. DEFINITIONS4.1. See HIPAA Security Definitions Policy.4.2. PECARN staff/members-Any personnel employed by PECARN related institutions that are involved in

PECARN research activities.4.3. PECARN information systems-Any computer related systems that are used to electronically transmit data

or information related to PECARN research, for example but not limited to, eRoom, ™, email systems, and data entry systems.

5. RESPONSIBILITYPECARN staff/members and the CDMCC.

6. PROCEDURE

6.1. User Access Roles and Responsibilities

6.1.1. For each study, the lead investigator will identify a site investigator for each participating site. 6.1.2. Each site investigator or nodal administrator will identify the names and roles of appropriate people

who need access to data systems and will notify the CDMCC when there are changes in roles or personnel at the site so that system access can be granted or rescinded.

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6.1.3. CDMCC may terminate or deny access to any PECARN member if there is a violation in any existing PECARN policy related to study data, or if there is any question about data security.

6.1.4. The CDMCC will provide access to data systems, passwords and other appropriate information at the request of the PECARN investigators or nodal administrators.

6.1.5. The CDMCC will review account activity on a regular basis.

7. References7.1. 45 CFR 164.3127.2. UUHSC Policy Manual 

 

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STANDARD OPERATING POLICY AND PROCEDUREINFORMATION SYSTEMS AND DATA MANAGEMENT

DATA MANAGEMENT, DOCUMENTATION AND RETENTION

1. POLICY1.1. PECARN protocols must have a Data Management Plan (DMP) designed to ensure that the

management of the data meets the standards set out in the protocol. The DMP must be reviewed and approved by the Study PI and CDMCC prior to protocol initiation.

1.2. Each DMP should embrace the whole life-cycle from data base design to long term preservation or possible destruction, and should aim to:

1.2.1. Align PECARN’s data management arrangements with applicable regulations and guidelines.

1.3. PECARN/CDMCC requires that all data management practices comply with Federal regulations (21 CRF Part 11) and Good Clinical Practice (GCP) Guidelines.

2. PURPOSE2.1. This policy describes how PECARN investigators and CDMC staff will carry out their

responsibilities for managing, documenting, retaining and preserving study data.

3. SCOPE3.1. This policy applies to PECARN investigators and CDMCC, and other persons participating in

PECARN research.

4. DEFINITIONS4.1. Data Management is the management of data elements collected during the conduct of the study

to ensure the quality and accuracy of data, compliance with Federal regulations and Good Clinical Practice guidelines.

4.2. The lead investigator-the investigator who received official Steering Committee approval to conduct the study and who provides leadership of the conduct of the study.

4.3. The site investigator-the investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN or PECARN related site.

4.4. The HEDA investigator-is the investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

4.5. PECARN Investigators-Investigators approved by PECARN steering committee to conduct PECARN related research activities.

5. RESPONSIBILITYPECARN investigators and the CDMCC.

6. PROCEDURES

6.1. Data Elements and e-CRFs:

6.1.1. The protocol specific data elements should be included in the protocol and submitted to CDMCC for review and approval.

6.1.2. The protocol specific data elements should include a study completion schedule describing which data elements will be completed at each clinical event in a protocol-

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specific logical order. Also include information concerning data elements that are contingent on other data elements (i.e., hospitalizations and SAEs).

6.1.3. CDMCC will convert the data elements list into e-CRFs (electronic screens for data abstraction and entry).

6.1.4. The study PI and CDMCC will assess planned protocol amendments for impact on the e-CRFs. Changes to the e-CRFs must be submitted with the protocol amendment to CDMCC. The CDMCC will make required database changes prior to implementation of the amendment based on the availability of resources.

6.2. Data Collection:

6.2.1. A plan for data collection shall be documented. 6.2.2. CDMCC shall document the procedures used by the site to maintain the integrity of

blinded data (if applicable).6.2.3. Study Sites shall enter study data via the electronic data capture (EDC) systems hosted by

CDMCC. These systems will be the official database(s) for the study.

6.3. Data Entry and Processing:6.3.1. Sites are responsible for entering complete, reliable and accurate study data into the

electronic systems hosted by CDMCC. The CDMCC shall describe acceptable time frames for data entry and data correction.

6.3.2. CDMCC requires that the Site PI or designee will be responsible for the review and approval of electronic study data. This will be done using an electronic approval method that is the equivalent of the investigator signature.

6.3.3. The CDMCC shall document the rules for handling data ranges, data types and coding of missing data. The rules must be reviewed and approved by the Study PI and CDMCC prior to implementation.

6.3.4. The CDMCC must describe quality control procedures; clinically significant data quality and consistency checks, and documentation of changes to data. The QC procedures must be reviewed and approved by the Study PI and CDMCC prior to implementation.

6.3.5. At the completion of the study, all study data must be final, complete (all data entered into the system), cleaned (all data discrepancies must be corrected and completely resolved), audited (all required quality assurance and quality control activities must be performed as well as the final site visit by CDMCC or designee) and locked for analysis within three months of the last participant’s exit from the study.

6.3.6. The CDMCC should specify the processing of any study data collected outside the CDMCC hosted electronic systems during the conduct of a protocol as well as at the end of the protocol completion.

6.4. Training:6.4.1. Study staff must complete training on all electronic systems hosted by CDMCC. Each

staff member must successfully complete the required test cases and demonstrate competency in the tasks he/she will perform for the study. CDMCC will grant the user the systems access to perform those duties only after training is completed and competency demonstrated.

6.4.2. CDMCC will maintain a record of staff training.6.4.3. CDMCC may provide training through a web-based training program and other remote

training methods for the systems hosted by CDMCC. CDMCC may offer on-site training as appropriate.

6.5. Record Retention:

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6.5.1. Records retention will be described in the protocol and will reflect federal regulations and funding agency requirements.

6.5.2. Indicate how long the records will be retained and when the process begins.

6.6. Review of Data Management Plan:

6.6.1. DMPs should be reviewed periodically to evaluate effectiveness and determine the need for revision. The DMP should describe the frequency and process for this review.

6.6.2. Revised DMPs will be submitted to lead investigator and CDMCC.

7. REFERENCES7.1.1. 21 CFR 312.62 7.1.2. 21 CFR 812.1407.1.3. ICH E6, 5.57.1.4. FDA Guidelines

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STANDARD OPERATING POLICY AND PROCEDURE FOR CREATING A PUBLIC USE DATASET

1. PURPOSE

Data from PECARN studies constitutes an important scientific resource. Their full value can only be realized if they are made available, under appropriate terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of qualified investigators.

2. SCOPE

Under no circumstances will data relating to an individual be distributed in any way that is inconsistent with his or her informed consent. Data sets without an informed consent permitting use by non-study researchers will only be released if the requester's IRB has approved a waiver of informed consent based on minimal risk to the participants [see Institutional Review Board policy].

Data sets distributed under this policy include only data with personal identifiers and other variables that might enable individual participants to be identified, such as outliers, dates, and study sites, removed or otherwise modified. Because it may still be possible to combine the data with other publicly available data and thereby determine with reasonable certainty the identity of individual participants, these data sets are not truly anonymous. They will, therefore, only provided to investigators who agree in advance to adhere to established policies for distribution.

Data sets will be available for all PECARN studies unless HRSA deems them to be unreliable or invalid. The CDMCC will prepare each dataset with a detailed data dictionary to describe variables and study criteria used to collect data.

3. DEFINITIONSPublic Use Data - Information collected and recorded from study participants through periodic examinations and follow-up contacts, not to include original specimens or images that are exclude any information that can potentially identify a specific study participate or study site.

Limited Data Set - A data set consisting of all records except those for participants who requested that their data not be shared beyond the initial study investigators.

4. PROCEDURES

The CDMCC will prepare a dataset to be stored on a CD ROM or USB drive unless the investigators and the HRSA mutually agree upon an alternative storage medium. Both the comprehensive documentation (i.e. a data dictionary) and study data must be prepared in a consistent format and readily accessible format.

The CDMCC will maintain a list and brief description of available datasets on the www.pecarn.org website. Investigators will request the use of a specific dataset by submitting a formal request that includes;

a description of the how the dataset will be used a signed data use agreement approval from their IRB for use of the dataset

The CDMCC will disseminate the dataset after receipt of the aforementioned items.

Technical assistance or questions related to the dataset will be provided by the original study investigator at his/her convenience.

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5. TIMING RELEASE OF PUBLIC USE DATA

Data will be made available by the CDMCC 3 years after the last patient completed the study or 1 year after the primary manuscript for the study has been published, whichever comes sooner.

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STANDARD OPERATING POLICY AND PROCEDURE FOR PERSONNEL TRAINING

1. POLICY1.1 PECARN personnel who are working in or overseeing research with human subjects will receive

training regarding the ethically and scientifically sound conduct of human subject research. Proper documentation provides evidence that personnel are qualified by training and experience to conduct their duties. This standard operating policy and procedure provides a guideline for the procedures and documentation of training of personnel who design, manage and monitor clinical studies within PECARN.

1.2 PECARN sites are required to maintain a record of all training documentation pertaining to the performance of clinical trials and protection of human subjects will be maintained at the site. This includes training required by the local institution, PECARN trainings, external trainings and clinical licensure/certifications.

1.3 Documentation of training will be maintained and organized by the site in a logical fashion, and in a manner easily available for inspection.

2. PURPOSEIt is the intent of PECARN to comply with federal regulations and guidelines and follow the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP).

3. DEFINITIONS3.1. The HEDA investigator is the investigator who is responsible overall for the site’s participation

in the PECARN.

3.2. The lead investigator-the investigator who received official Steering Committee approval to conduct the study and who provides leadership of the conduct of the study.

3.3. The site investigator-the investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN or PECARN related site.

3.4. The HEDA investigator-is the investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

4. SCOPEThese procedures apply to all key personnel. Key personnel include all individuals that are responsible for developing, managing conducting, and monitoring clinical studies within PECARN.

4. RESPONSIBILITY 4.1 The site investigator is responsible for ensuring that all employees are qualified by training and

experience to conduct their designated research-related duties. In cases where site personnel begin work after initial protocol trainings, the site investigator is responsible for ensuring completion of proper training and documentation.

4.2 The site investigator is responsible for overseeing fulfillment and documentation of local site specific training requirements. Documentation of external trainings, medical licensure, and certifications of site personnel will also be overseen and maintained by the site investigator.

4.3 The lead investigator will develop a protocol specific training plan and curriculum.

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4.4 The lead investigator will be responsible for ensuring that the proper training is completed and documented, in cases where a site investigator begins working on a study after the protocol specific trainings.

4.5 The Central Data Management Coordinating Center (CDMCC) will assist in the development of protocol specific curriculum, implementation of the training plan and documentation of PECARN protocol training attendance.

4.6 The Nodal PI will provide oversight and assistance in fulfilling the training requirements. Non compliance with training requirements will be referred to the Nodal PI for remediation.

4.7 The Nodal PIs will determine the general research and GCP training needs for the PECARN Steering Committee (SC) and other investigators.

4.8 The CDMCC will assist in providing GCP and general research training at the request of the SC chair. Options for providing training include the PECARN SC meetings, study specific training, nodal training, on line education, and local training provided by the specific hospital.

4.9 Nodes will assess training needs within their HEDAs/Node and make arrangements for training as needed using local or PECARN resources.

5. PROCEDURES5.1 The site will maintain documentation of training in the essential documents binder (EDB) or in

another specified location listed in the EDB.

5.2 CDMCC will track required PECARN protocol specific training in eRoom or other designated location as requested by the Lead Investigator of the study.

5.3 The site will provide documentation of training for inspection by the PECARN site monitor or other appropriate personnel.

5.4 Following protocol approval by the PECARN steering committee, the CDMCC will provide assistance to the Lead Investigator to develop a timeline for training RA, PI and other appropriate individuals involved in the study.

5.5 The CDMCC will assist the Lead Investigator in fulfilling PECARN committee recommendations regarding training programs needed for the protocol. The CDMCC will assist the steering committee, as requested, in preparing general research lecture topics and recruiting presenters.

5.6 GCP and research training will be integrated into the PECARN steering committee meetings at the discretion of the Nodal PIs. GCP training and pertinent research information will be incorporated in study training sessions, regular protocol teleconferences, and site monitoring visits.

5.7 CDMCC will provide sign in sheet or other method for documenting training in PECARN sponsored trainings. For other trainings held nodally or locally, the Nodal Administrator or site investigator will maintain training documentation listing the date, name and signature of attendees, and course topic. Attachment A provides a sample training sign-in sheet.

6. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.50 General Responsibilities of Sponsors21 CFR 312.53 Selecting Investigators and Monitors21 CFR 812.40 General Responsibilities of Sponsors21 CFR 812.43 Selecting Investigators and MonitorsICH E6, 2.8 The Principles of ICH GCPICH E6, 5.5 Trial Management, Data Handling, and Record KeepingICH E6, 5.18.2 Selection and Qualification of Monitors

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NIH Notice OD-00-029 Required Education in the Protection of Human Research Participants (June 5, 2000)

NIH Notice OD-00-039 Clarification on June 5, 2000 Notice (Sept 12, 2000)

7. REFERENCES TO OTHER APPLICABLE SOPs

This SOP affects all other SOP.

8. DEFINITIONS

8.1 Data Management is the management of data elements collected during the conduct of the study to ensure the quality and accuracy of data, compliance with Federal regulations and Good Clinical Practice guidelines.

8.2 The lead investigator-the investigator who received official Steering Committee approval to conduct the study and who provides leadership of the conduct of the study.

8.3 The site investigator-the investigator who is identified by the lead investigator as being responsible for conduct of the study at a designated PECARN or PECARN related site.

8.4 The HEDA investigator-is the investigator identified in the PECARN cooperative agreement as the individual providing leadership and oversight of all PECARN related research at the respective site.

8.5 PECARN Investigators-Investigators approved by PECARN steering committee to conduct PECARN related research activities.

9. ATTACHMENTS

Attachment A: Training Program Sign-in, Sample

Attachment A

TRAINING PROGRAM SIGN IN, SAMPLE

Training Program Title

Date (s): ____________________ Presenter: ________________

Date(s) Participant Job TitleParticipant

NameParticipant Signature

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