introduction to pre-award partners research management june 2011 © partners healthcare system,...

Introduction to Pre-Award

Partners Research Management

June 2011

© Partners HealthCare System, Inc., 2011 Reference Material

ProposalDevelopment (PD) Locate Funding &

Complete Proposal Package

Institutional

Review

Record Creation (PT)

ProposalSubmission

Account set up

Prior Approval requests

Incurring Costsand

Purchasing

Tracking and

Accounting

SponsorReports

and Close-outs

MoreMoney!

Grant LifecycleGrant Lifecycle

Post-Award

Research

Finance

and/or

Signature

Approval

Contracts

Negotiate & execute incoming & outgoing subcontract & contract agreements

Just-in-Time submission

Progress Report review & Submission

Department Pre-Award

Pre-Award Teams

• Director of Pre-Award Services – Susan Roudebush

• BWH Pre-Award Manager – Sandie Robinson (starting July 8)

• BWH Pre-Award is additionally supported with a “Buddy System”

• MGH Pre-Award Manager – Paula Cobbett

Common Sponsors and Funding Organizations

• Federal SponsorsFederal Sponsors

– Department of Health and Human Services (DHHS)

• National Institutes of Health (NIH)

– 27 Institutes and Centers within the NIH

» National Cancer Institute (NCI)

» National Center for Research Resources (NCRR)

– National Science Foundation (NSF)

– Department of Defense (DOD)

– National Aeronautics and Space Administration (NASA)

• Non-Federal OrganizationsNon-Federal Organizations

– American Heart Association

– American Cancer Society

– Robert Wood Johnson Foundation

– Pew Charitable Trust

– John D. & Catherine T. MacArthur Foundation

– Burroughs Wellcome Fund

N ation a l Can cerIn s titu te

N ation a l In s titu teso f Hea lth

D epartm ent ofH ea lth and H um an

S ervices

Research Institutions• Partners is composed of multiple legal entities, each with their own Federal Identification

Number and accounts. A few of them are represented here.

Partners HealthCare

Mass General Hospital

Brigham and

Women’sHospital

Spaulding Rehab

Harvard Medical School

Dana Farber Cancer Institute

• Partners entities also work with organizations that are not part of the Partners HealthCare System, but they collaborate closely on research.

• Grants may be awarded to a Partners entity as the prime recipient and then a portion of the research may be subcontracted out to an affiliate or another institution to complete under the terms of a subcontract. For example, MGH may be the prime and DFCI the subcontract, as shown here.

• Both the prime recipient and the subcontractor must adhere to Sponsor guidelines

McLeanHospital

BroadInstitute

Types of Grant and Cooperative Agreement Announcements

– Parent Announcements Parent Announcements – All electronic grant applications must be submitted in response to a Funding Opportunity Announcement (FOA). Provides guidance regarding the application process.

– Program Announcements (PA)Program Announcements (PA) – A formal statement about a new or ongoing extramural activity of mechanism. Most PAs have a standing submission date.

– Requests for Applications (RFA) –Requests for Applications (RFA) – A formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. Will specify the amount of funding available, number of awards to be made and the specific application date. Includes detailed and specific information regarding how to apply.

– Broad Agency Announcements (BAA)Broad Agency Announcements (BAA) - Is a competitive solicitation procedure used to obtain proposals for basic and applied research from a federal agency. A BAA will also specify the general terms and conditions under which an award may be made.

– Request for Quotations (RFQ)Request for Quotations (RFQ) - Is also a competitive solicitation procedure. A request for quotation (RFQ) is a document that an organization submits to one or more potential suppliers eliciting quotations for a specific service or product. Typically, an RFQ seeks an itemized list of prices for something that is well-defined and quantifiable, such as lab tests.

– Request for Proposals (RFP)Request for Proposals (RFP) - is a formal statement that invites grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. The RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, and the application receipt date(s).

Types of Applications

• Competing ApplicationsCompeting Applications – New or resubmitted applications that must undergo initial peer review.

• Competitive RenewalCompetitive Renewal - An application requiring competitive peer review and Institute/Center action to continue beyond the current competitive segment.

• Administrative Supplement Administrative Supplement - Monies added to a grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted.

• Resubmitted ApplicationResubmitted Application - Unfunded application that has been resubmitted for consideration. NIH allows only one resubmission.

• Non-Competing ContinuationNon-Competing Continuation – A year of continued support for a funded grant. Progress reports for continued support do not undergo peer review but are administratively reviewed by the Institute/Center and receive an award based on prior award commitments.

• No-Cost ExtensionNo-Cost Extension – Request for additional time beyond the years previously awarded.

• Modification Modification - Change Order or Supplemental Agreement not meeting the requirements for a renewal as shown above; however, if issued, it would amend one or more provisions of an existing contract (i.e., extensions of less than six months, overhead adjustments and/or obligation of additional funds with or without extending the contract).

NIH Activity Codes for Funding Mechanisms

Activity Code - A three-digit code assigned by the National Institutes of Health (NIH) to identify funding mechanisms (e.g. F32, K12, P01, R01, T32, etc.). General categories include:

– F -- fellowships – K -- career development awards – N – federal contracts – P -- program project and research center grants – R -- research grants – S -- research-related programs – T -- training grants – U -- cooperative agreements – Y -- interagency agreements

NIH Award ID

― Application Type CodeApplication Type Code• Type 1 New• Type 2 Competing renewal• Type 3 Supplemental support• Type 4 Competing extension for an R37 award• Type 5 Non-competing continuation• Type 7 Change of grantee institution• Type 9 Change of NIH awarding Institute or Division (competing renewal)

― Activity CodeActivity Code - Type of Grant

― Institute CodeInstitute Code - two-letter NIH Institute abbreviation; e.g., NIAID's code is AI.

– Serial NumberSerial Number - unique serial number assigned by the Center for Scientific Review.

Grant Year

1 R01 CA 13499 -01 A1

Other

Application Type

Activity Code

Institute Code

Serial Number

Suffixes

NIH Award ID, cont.

– Federal IdentifierFederal Identifier – Institute Code + Serial Number (ex., CA123456), used for resubmissions

― Suffixes – Grant YearSuffixes – Grant Year - Support year for grant

― Other SuffixOther Suffix - The final two are codes for an resubmission, supplement, or fellowship institutional allowance

― AMENDMENT AMENDMENT – “A” identifies an amended application

― SUPPLEMENTSUPPLEMENT - "S" and related number identify a particular supplement; Supplement designations follow the grant year or the amendment designation, as the case may be; e.g., AI 12345-01S1 and CA 00900-04A1S2.

Grant Year

3 R01 CA 13499 -02 S1

Other

Application Type

Activity Code

Institute Code

Serial Number

Suffixes

Electronic Research Administration

Most sponsors have moved to electronic submission formats to reduce the administrative burden and accelerate the proposal process.

• Grants.gov (multiple Government funding sources)Grants.gov (multiple Government funding sources)• Grants.gov is a central storehouse for over 1000 grant programs and approximately $400

billion in annual awards. This is our main electronic submission environment• http://www.grants.gov/index.jsp

• NIH eRA CommonsNIH eRA Commons• Web interface where NIH and the grantee community are able conduct extramural research

administration business electronically• New department users and Investigators must contact their GA to establish an account• https://commons.era.nih.gov

• NSF FastLaneNSF FastLane• FastLane is an interactive real-time system used by the NSF• https://www.fastlane.nsf.gov/fastlane.jsp

• proposalCENTRALproposalCENTRAL• proposalCENTRAL is an e-grantmaking Website used by many Foundations, including the

American Cancer Society• https://proposalcentral.altum.com/

• Foundation WebsitesFoundation Websites• Some foundations such as Susan G. Komen Foundation and American Heart Association

have their own grant submission sites

What does the Signing Official signature on grant applications mean?

Applicants and grantees must comply with a number of additional public policy requirements, here is the list of what the Signing Official’s signature attests we are in compliance with:

• Human Subjects Research• Research on Transplantation of Human Fetal Tissue • Research Using Human Embryonic Stem Cells• Women and Minority Inclusion Policy• Inclusion of Children Policy• ClinicalTrials.gov Requirements• Vertebrate Animals• Debarment and Suspension• Drug-Free Workplace• Lobbying• Non-Delinquency on Federal Debt • Research Misconduct • Civil Rights• Handicapped Individuals• Sex Discrimination• Age Discrimination• Recombinant DNA Research, including Human Gene Transfer Research• Financial Conflict of Interest • Smoke-Free Workplace• Prohibited Research• Select Agent Research• Project Director/Principal Investigator Assurance• Impact of Grant Activities on the Environment and Historic Properties

Internal Grant Review and Approval Deadlines

• Deadlines for DRAFT Submissions • 10 business days before Sponsor deadline

• The grant application and required internal documents must be submitted to Research Management by uploading to InfoEd PD or the secure website at http://insight.partners.org/documentsubmission/.

• InfoEd PD: All internal documents (PCS, COI) must be included, and administrative portions of the grant should be complete. Draft routing should be planned so the record is available for the GA to begin reviewing 10 days before the due date.

• If your department is not using InfoEd PD, the application and all required documents should be uploaded to the Insight Portal 10 days before the due date.

• Research Management comments will be communicated to the PI and/or Departmental Administrator within 5 business days of receipt.

• Deadline for FINAL submissions• 5 business days before Sponsor deadline

• Administrative corrections should be completed and the Final application record available for review. Upon confirmation from the Department Administrator or PI, the application will be submitted .

IACUC – Institutional Animal Care and Use Committee

• The IACUC Review board assures that type and number of animals requested in a protocol are appropriate and that the Investigators and other laboratory personnel complete the federally mandated training for the care and use of laboratory animals.

• The IACUC oversees the facilities and monitors all activities to assure that animals are treated humanely and with proper care, and that the animal care facility is in compliance with all relevant government laws, regulations and policies.

• Please refer to:Guide for the Care and Use of Laboratory Animals: Eighth Editionhttp://www.nap.edu/catalog/12910.html

• The IACUC approval should be listed as “Pending” on an application when it is initially submitted. If a Just-in-Time (JIT) requests IACUC approval, then it is submitted with other JIT requested elements.

• Investigators must submit an IACUC protocol approval request for all new awards even if similar work has already received IACUC approval or the PI can request a modification to an already approved protocol to have the new award and users listed.

• The Institutional Review Board for the Use of Human Subjects reviews protocols and grant applications for research that involves human subjects

• Training and certification of study staff (CITI quiz and certification) is required prior to being allowed to work with human subjects or human related data: http://healthcare.partners.org/phsirb/education.htm

• IRB review and approval is required for all research using humans as part of the research

– May be documented as “Pending” when a proposal is initially submitted. The approval will be requested at Just-in-Time.

• HIPAA (Health Insurance Portability and Accountability Act of 1996)– Patient education on privacy/ access to medical records/ use of records for research

purposes

• The Partners Human Research Committee (PHRC) reviews all human subject protocols for Partners PIs: http://healthcare.partners.org/phsirb/

• New research awards must undergo IRB review even if similar work has already received IRB approval or the PI can request a modification to an already approved protocol to have the new award and users listed.

IRB – Institutional Review Board

Possible Additional Approvals

• Human Embryonic Stem Cells (ESCRO)Human Embryonic Stem Cells (ESCRO) – Research involving human embryonic stem cells requires ESCRO approval

• http://healthcare.partners.org/phsirb/guidance.htm

• BiohazardsBiohazards – Biosafety committee approval is required for research using hazard chemicals or agents

BWH Biosafety Officer - Ted Myatt, [email protected] 617-964-8550

Environmental Health and Safety Office at MGHhttp://intranet.massgeneral.org/ehs/ehs_home.htm

• Recombinant DNA (rDNA)Recombinant DNA (rDNA) – Approval is required for research involving the transfer of rDNA work.

• Export ControlsExport Controls – Research involving the export of materials or technology to certain foreign countries may be restricted by Federal regulations. The Institutional Research Compliance Office can assist in the event special licensing is required

• http://resadmin.partners.org/RM_Home/Documents/RMPolicies/ExportControlPolicy.pdf

Allowability and Allocability• Certain conditions must be met for a potential budget line item to be included in the

proposal budget. Each budget line item must be:

• AllowableAllowable - eligible for reimbursement– Pursuant to Federal or Sponsor Guidelines

– Sample budget items that are not permitted on Federal Grants:– Alcoholic beverages and other entertainment costs– General or University-related marketing activities– Lobbying of Government Officials– Fund raising costs

• Allocable Allocable - able to be applied to a specific cost category– Incurred solely to advance the work under the sponsored agreement– Benefits both the sponsored agreement and other work of the institution in

proportions that can be approximated through use of reasonable methods– Necessary to the overall operation of the institution and, in light of the principles

provided in the OMB Circulars, is deemed to be assignable in part to sponsored projects

Modular Budgets

• For certain grant mechanisms, NIH provides the opportunity to apply for funding under a less stringent set of budget guidelines in order to reduce the administrative burden on both the Grantee and Sponsor

• Modular grants require less detail in the proposal budget and accounting

– Projects must be $250,000 or less per year in direct costs– Request budget in $25,000 increments– Non-detailed budget – Direct and Indirect Costs only– Budget Justification should only include Personnel, Consortium Justification and

justification of any unusual expenses that require additional $25,000 modules in any year

• http://grants.nih.gov/grants/funding/modular/modular.htm

F&A (Facilities and Administrative) Costs

• F&A costs are expenses incurred for common or joint activities – cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity.

– Examples: Building maintenance costs, electricity, phone charges

• F&A costs are applied to direct costs, excluding equipment, subcontracts greater than first $25,000, patient care costs, alteration and renovations, and animal expenses (please refer to individual Institutional Rate Agreement).

• Each Partners entity negotiates a multi-year agreement of predetermined F&A rates with DHHS each year. The current applicable rates are available on the Partners intranet site.

• Partners policy requires that the full negotiated F&A rate be used for all Sponsors (Federal, Foundation, and Industry). An exception is made for foundations, non-profit sponsors and government agencies with explicit, published policies limiting F&A recovery to a lesser amount. This will be specified in the proposal guidelines or online at the sponsor’s website. Any other exceptions to the Partners F&A policy require the approval of the institution's Sr. Vice President for Research.

http://phsresearchintranet.partners.org/PHS_ResearchMgmt/documents/RMPolicies/F&ACostsPolicy.pdf

Cost Sharing

– MandatoryMandatory = required by sponsor – approved by Director of Pre-award– Voluntary committedVoluntary committed = offered by grantee – approved by BWH/MGH Sr. Vice

President

What kind of cost sharing is required?– MatchingMatching - Cost sharing where the institution will match the financial value of the

sponsor’s grant to help fund that specific project– In-KindIn-Kind - Cost sharing where costs are borne by an external organization, for

example when individuals at another organization volunteer their time

• Many institutions, including Partners, have policies limiting voluntary cost sharing. For this reason, Departmental and Research Management approval of all cost sharing is required at the time of proposal.– Determining a source of secondary funding can delay the proposal

process – Correct signatures/approvals ensure that voluntary cost sharing is not

inadvertently written into the proposal and that any voluntary cost sharing that cannot be eliminated is minimized

Other Support

Additional information regarding Other Support, cont.:Additional information regarding Other Support, cont.:• Do not submit information on Other Support with the application beyond that required in the Do not submit information on Other Support with the application beyond that required in the

biographical sketch.biographical sketch. If this information is included at the time of application, processing may be

delayed or the application may be returned to the applicant without review. • Don’t confuse “Research Support” with “Other Support.”Don’t confuse “Research Support” with “Other Support.” Though they sound similar, these parts

of the application are very different. As part of the biosketch section of the application, “Research Support” highlights your accomplishments, and those of your colleagues, as scientists. It is used by reviewers for the “investigator” review criterion. In contrast, “Other Support” information is required for all applications that are selected to receive grant awards. NIH staff will request complete and up-to-date “Other Support” information from you after peer review. This information will be used to check that the proposed research has not already been Federally-funded.

• Information on Other SupportInformation on Other Support assists awarding agency staff in the identification and resolution of potential overlap of support. Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

• Budgetary overlapBudgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided for by another source.

• Commitment overlapCommitment overlap occurs when a person’s time commitment exceeds 100 percent, whether or

not salary support is requested in the application.

Other Support

Continued:Continued:

• Scientific overlap occurs whenScientific overlap occurs when:: (1) substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or (2) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source.

• Resolution of OverlapResolution of Overlap - - Resolution of overlap occurs at the time of award in conjunction with

applicant institution officials, the principal investigator, and awarding agency staff. Information on active and pending Other Support is required for Key Personnel, excluding

consultants. For individuals with no active or pending support, indicate “None.” Neither the application under consideration nor the current PHS award for this project should be

listed as Other Support. Do not include Other Support for individuals listed as "Other Significant Contributors" unless their

involvement has changed so that they now meet the definition of "key personnel."

Other Support

Components of Other Support Submission:Components of Other Support Submission:

• Project NumberProject Number:: If applicable, include a code or identifier for the project.

• SourceSource:: Identify the agency, institute, foundation, or other organization that is providing the support.

• Major Goals:Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or subcontract.

• Dates of Approved/Proposed Project:Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment.

• Annual Direct Costs:Annual Direct Costs: In the case of an active project, provide the current year’s direct cost budget. For a pending project, provide the proposed direct cost budget for the initial budget period.

• Level of Effort:Level of Effort: For an active project, provide the level of actual effort (even if unsalaried) for the current budget period. For a pending project, indicate the level of effort as proposed for the initial budget period.

• Overlap:Overlap: After listing all support, summarize for each individual any potential overlap with the After listing all support, summarize for each individual any potential overlap with the active or pending projects and this application in terms of the science, budget, or an individual’s active or pending projects and this application in terms of the science, budget, or an individual’s committed effort.committed effort.

Questions? Darlene Jackson - 954-9725

[email protected]

Joanne Maldonis - 954-9646 [email protected]

© Partners HealthCare System, Inc., 2011

Appendix A

• Grants Terminology– Types of Grants & Cooperative Agreement Announcements

– Types of NIH Applications

– NIH Activity Codes

– Expanded Authorities

– Project Roles

– Budget Terminology

– Institution Specific

– Grants.gov

– General Terms - Alphabetical List

Types of Grant and Cooperative Agreement Announcements

– Parent Announcements Parent Announcements – All electronic grant applications must be submitted in response to a Funding Opportunity Announcement (FOA). Provides guidance regarding the application process.

– Program Announcements (PA)Program Announcements (PA) – A formal statement about a new or ongoing extramural activity of mechanism. Most PAs have a standing submission date.

– Requests for Applications (RFA) –Requests for Applications (RFA) – A formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. Will specify the amount of funding available, number of awards to be made and the specific application date. Includes detailed and specific information regarding how to apply.

– Broad Agency Announcements (BAA)Broad Agency Announcements (BAA) - Is a competitive solicitation procedure used to obtain proposals for basic and applied research from a federal agency. A BAA will also specify the general terms and conditions under which an award may be made.

– Request for Quotations (RFQ)Request for Quotations (RFQ) - Is also a competitive solicitation procedure. A request for quotation (RFQ) is a document that an organization submits to one or more potential suppliers eliciting quotations for a specific service or product. Typically, an RFQ seeks an itemized list of prices for something that is well-defined and quantifiable, such as lab tests.

– Request for Proposals (RFP)Request for Proposals (RFP) - is a formal statement that invites grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. The RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, and the application receipt date(s).

Types of Applications

• Competing ApplicationsCompeting Applications – Either new or re-competing applications that must undergo initial peer review.

• Competing ContinuationCompeting Continuation - An application requiring competitive peer review and Institute/Center action to continue beyond the current competitive segment. (Also known as a Renewal)

• Administrative Supplement Administrative Supplement - Monies added to a grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted.

• Revised/Amended ApplicationRevised/Amended Application - Unfunded application that has been “resubmitted” for consideration. Can resubmit max. of 1 time for NIH awards.

• Modular Application -Modular Application - A type of grant application in which support is requested in specified increments without the need for detailed supporting information related to separate budget categories.

• Non-Competing ContinuationNon-Competing Continuation – A year of continued support for a funded grant. Progress reports for continued support do not undergo peer review but are administratively reviewed by the Institute/Center and receive an award based on prior award commitments.

• No-Cost ExtensionNo-Cost Extension – Request for additional time beyond the years previously awarded.

• Modification Modification - Change Order or Supplemental Agreement not meeting the requirements for a renewal as shown above; however, alters or amends one or more provisions of an existing contract (i.e., extensions of less than six months, overhead adjustments and/or obligation of additional funds with or without extending the contract).

Expanded Authorities

Expanded Authorities - The operating authorities provided to grantees under certain research grant mechanisms that waive the requirement for Federal sponsor prior approval for specified actions. These authorities are inherent in each grant awarded by Federal sponsors, unless otherwise specified

– 90 days Pre-Award90 days Pre-Award - The federal government has authorized Institutions to approve pre-Award spending up to 90 days prior to the start date of the anticipated award.

– Re-budgetingRe-budgeting – The federal Government allows for the re-budgeting of funds up to 25% of the total approved budget except for the following items: direct costs moved to indirect costs or vice versa, training or fellowship costs

– Carry-OverCarry-Over - Unexpended funds are carried over from one budget period to the next without prior approval

– Time ExtensionTime Extension – The institution may apply for one time extension of up to one year in the final year of a grant.

NIH Activity Codes for Funding Mechanisms

Activity Code - A three-digit code assigned by the National Institutes of Health (NIH) to identify funding mechanisms (e.g. F32, K12, P01, R01, T32, etc.). General categories include:

– F -- fellowships – K -- career development awards – N -- research contracts – P -- program project and research center grants – R -- research project grants – S -- research-related programs – T -- training grants – U -- cooperative agreements – Y -- interagency agreements

Project Roles

• Key PersonnelKey Personnel – The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant.

• Principal Investigator (PI)Principal Investigator (PI) – An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible and accountable to the grantee and NIH for the proper conduct of the project or activity.Also known as Program Director or Project Director

• . • Co-Investigator (Co-I)Co-Investigator (Co-I) – An individual involved with the PI in the scientific

development or execution of a project. The co-investigator (collaborator) may be employed by, or be affiliated with, the applicant/grantee organization or another organization participating in the project under a consortium agreement. A co-investigator typically devotes a specified percentage of time to the project and is considered “key personnel.”

• Post-DocPost-Doc – A professional who has completed their doctoral degree, but is not likely to serve as a Principal Investigator.

• Other Significant Contributor Other Significant Contributor - individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (in person months) to the project. These individuals are typically presented at “effort of zero person months” or “as needed”

• ConsultantConsultant - An individual providing professional advice or services on the basis of a written agreement for a fee. These individuals are not normally employees of the organization receiving the services. Consultants also include firms providing professional advice or services.

Project Roles cont.

Budget

• Budget PeriodBudget Period – The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.

• Project Period Project Period – The total time for which support of a project has been programmatically approved. Comprises the initial competitive segment, any subsequent competitive segment(s) resulting from a competing continuation award(s), and non-competing extensions.

• Total Project CostsTotal Project Costs - The total allowable costs (direct costs, F&A costs and cost sharing) incurred by the grantee to carry out a grant-supported project or activity.

• EquipmentEquipment - An article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds $5,000 or the capitalization threshold established by the organization, whichever is less.

• Stipend Stipend - A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.

• Modified Total Direct Costs (MTDC)Modified Total Direct Costs (MTDC) – Common Base method for calculating the F&A Amount on a proposal.

Budget cont.

• NIH Salary CapNIH Salary Cap – Salary limitation on grants, cooperative agreements and contracts. $199,700 for institutional base salary for 2010 – (needs to be used when calculating project salary expense as well).

• Salary Cap LimitationSalary Cap Limitation - A legislatively-mandated provision limiting the direct salary (also known as salary or institutional base salary, but excluding any fringe benefits and F&A costs) for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts.

• Direct CostsDirect Costs – Costs that can be specifically identified with a particular project or activity.

• Facilities and Administrative Costs (F&A)Facilities and Administrative Costs (F&A) - Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program. These costs are also known as "indirect costs."

• Institutional Base SalaryInstitutional Base Salary - The annual compensation paid by an applicant/grantee organization for an employee's appointment whether that individual's time is spent on research, teaching, patient care, or other activities. The base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds.

Institution Specific

• Data Universal Numbering System (DUNS)Data Universal Numbering System (DUNS) – The DUNS number is a unique nine-digit number assigned by Dun and Bradstreet Information Services. It is recognized as the universal standard for identifying and keeping track of more than 92 million businesses worldwide. Grants.gov requires a DUNS number for registration. For applicants, the DUNS number in the application must match the DUNS number in the Institutional Profile in Commons.

• Employer Identification Number (EIN)Employer Identification Number (EIN) - Identification of a business to the U.S. Internal Revenue Service; also known as a Federal tax identification number. Entered on the SF 424 form of a grant application.

• Animal Welfare AssuranceAnimal Welfare Assurance - Document an institution and all performance sites involving animals in research must have on file with the Office of Laboratory Animal Welfare before a Public Health Service Agency may award a grant or contract.

• Federal Wide AssuranceFederal Wide Assurance - Online form every institution and collaborating institution conducting human subjects research must file with the Office for Human Research Protections – HHS to establish policies and procedures to protect human subjects as required by 45 CFR 46.

Terminology specific to Grants.gov submissions

• Grants.govGrants.gov - An access point through which any person, business, or State, local, or Tribal government may electronically find and apply for more than 1,000 competitive grant opportunities from the 26 Federal grant-making Agencies.

• ErrorError – Any condition causing an electronically-submitted application to be deemed unacceptable for further consideration. Generally, errors will indicate significant inaccuracies, inconsistencies, omissions or incorrect formatting. The error needs to be corrected by the applicant and the application submitted again as a changed/corrected application via Grants.gov

• WarningWarning - Any condition in an electronically-submitted grant application acceptable but worthy of bringing to the applicant's attention. It is left to the applicant's discretion to take any corrective action. The application goes forward even if the warnings are not corrected.

• RevisionRevision – Grants.gov term for money added to a grant to expand its scope or meet needs of a research protocol. Applicants must apply and undergo peer review.

• Resubmission Resubmission - Grants.gov term for a grant application resubmitted to NIH after a PI applicant who did not succeed in getting funded revises it based on feedback from the initial peer review. NIH term was "revision.“ Each resubmission has an entry in its application identification number, e.g., A1, A2. NIH limits applicants to one resubmission.

• ValidationValidation - The systematic check of applications against the NIH application guide and Funding Opportunity Announcement instructions. The process can generate errors or warnings.

• On timeOn time - Electronic applications are on time if successfully submitted to Grants.gov by 5 p.m. local time on the date indicated.

Common NIH Terms – Alphabetically Listed

• Affiliate – a collaborative non-profit organization that is not part of an Institution, but maintains a close working relationship.

• Authorized Organizational Representative (AOR) – The individual authorized by the applicant organization to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This official is equivalent to the SO in NIH’s eRA Commons. Responsibilities include: Submitting the grant on behalf of the company, organization, institution, or Government; Signing grant applications and the required certifications and/or assurances necessary to fulfill the requirements of the application process.

• Bridge funding– Provides one year of funding so investigators can continue research while reapplying for an R01 grant or enables new investigators to gather preliminary data to improve their applications. Investigators do not apply for Bridge Awards but are selected from R01 grants at the pay-line margin.

• Center for Scientific Review (CSR) – The NIH component responsible for the receipt and referral of applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH.


• Competitive Segment - The initial project period recommended for support (in general, up to 5 years) or each extension of a project period resulting from a competing continuation award.

• Conflict of Interest– Regulations to ensure Government employees, scientific review group members, Council members, or others having the ability to influence funding decisions have no personal interest in the outcome.

• Electronic Streamlined Non-competing Award Process (eSNAP) - Process allowing an institution to review non-competing grant data and submit a progress report online.

• eRA Commons - A secure meeting place on the Web where research organizations and grantees electronically receive and transmit information about the administration of research grants.

• Federal Acquisition Regulations (FAR) – Laws regulating government contracting. • Final Proposal Revision (FPR) - After completion of negotiations, offerors are asked

to submit a final proposal revision which documents all cost and technical agreements reached during negotiations.


• Foreign Component – The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended.

• Grantee - The organization or individual awarded a grant or cooperative agreement by NIH that is legally responsible and accountable for the use of the funds provided and for the performance of the grant-supported project or activities.

• Institutional Business Official - Person working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the Commons' Signing Official (SO).

• Just In Time - Within the Status module of the eRA Commons, users will find a feature to submit Just-In-Time information when requested by the NIH. NIH policy allows the submission of certain elements of a competing application to be deferred. Through this module, institutions can electronically submit the information that is requested after the review, but before award.


• Matching or Cost Sharing - The value of third party in-kind contributions and the portion of the costs of a federally assisted project of program not borne by the Federal Government. Matching or cost sharing may be required by law, regulation, or administrative decision of an NIH Institute or Center. Costs used to satisfy matching or cost sharing requirements are subject to the same policies governing allowability as other costs under the approved budget

• Multiple PI – Individual research awards in which more than one Principal Investigator (PI) is identified by the applicant or institution.

• New Investigator - A new investigator is an individual who has not previously competed successfully for an NIH-supported research project other than the following small or early stage research awards

• Pre-Application - A statement in summary form of the intent of the applicant to request funds. It is used to determine the applicant's eligibility and how well the project can compete with other applications and eliminate proposals for which there is little or no chance for funding.

• Pre-Award Spending – Authorization provided by the sponsor under expanded authority to begin spending the funds issued in a grant up to 90 days before the grant is awarded.


• Progress Report – Periodic, usually annual, report submitted by the grantee and used by NIH to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report.

• Review Cycle - Refers to the Center for Scientific Review's thrice yearly initial peer review cycle, from the receipt of applications to the date of the review.

• Specific Aims - A component of an application’s Research Plan which describes concisely and realistically what the proposed research or activity intends to accomplish by the end of the grant. Includes broad, long-term goals; hypothesis or hypotheses to be tested; and specific time-phased research objectives.

• Statement of Work (SOW) – In a contract proposal, the detailed description of the work to be performed under the contract.

• Subcontract/Subaward – Collaborative arrangement in support of a research project in which part of an activity is carried out through a formal agreement between a grantee and one or more other organizations. Also known as consortium agreement

Appendix B

Federal & Non-Federal Funding Opportunity Resources (listed Alphabetically)

Funding Opportunity Resources

• Agency for Health Care Research and Quality, formerly the Agency for Health Care Policy and Research (AHCPR) focuses primarily on opportunities for investigator-initiated research grants; however, brief information is also included on contracts. http://www.ahcpr.gov/fund/index.html

• American Cancer Society is the largest non-government funder of cancer research in the United States. Since our Research Program began in 1946, the ACS has devoted more than $2 billion to cancer research. http://www.cancer.org/Research/ResearchProgramsFunding/index

• American Health Assistance Foundation (AHAF) is one of America's leading supporters of scientific and medical investigations into Alzheimer's Disease, Glaucoma, Macular Degeneration, Heart Disease, and Stroke. http://www.ahaf.org

• American Heart Association's financial contribution to cardiovascular research is very impressive for a publicly funded health organization. The Association has carved an important niche in supporting the development of beginning investigators and offering innovative funding mechanisms to stimulate research in promising science areas. http://www.americanheart.org/research/

• Centers for Disease Control and Prevention (CDC), located in Atlanta, Georgia, USA, is an agency of the Department of Health and Human Services. The CDC awards nearly 85 percent of its budget through grants and contracts to help accomplish its mission to promote health and quality of life by preventing and controlling disease, injury, and disability.

http://www.cdc.gov/od/pgo/funding/grantmain.htm

• Community of Science is the most comprehensive source of funding information available on the Web, with more than 16,000 awards from around the world. There is a fee for search use (Individuals: $500; Institutions: $500-1500). http://fundingopps2.cos.com/

• Dana Foundation - The Health grants program supports brain research focused on preventing, diagnosing, or treating human neurological diseases and disorders. http://www.dana.org/grants/


• Foundation Center is a nonprofit information clearinghouse. In order to use their online services, you have to subscribe monthly. http://www.foundationcenter.org/

• GrantsNet is a comprehensive listing of (with links to) science/medical grant listing sites compiled by the Howard Hughes Medical Institute and the AAAS (American Association for the Advancement of Science). The user signs in (free) and can then pick an area of specialty for funding opportunities from over 700 federal and private sources. Also contains helpful short essays on grant writing, the federal grant review process, etc. http://www.grantsnet.org

• Health Resources and Services Administration (HRSA) has Information about grants available from Health Resources and Services Administration's Bureau of Primary Health Care, the Bureau of Health Professions, Bureau of Maternal and Child Health, and the HIV/AIDS Bureau. http://www.hrsa.gov/grants/index.html



• March of Dimes - Qualified scientists with faculty appointments or the equivalent, at universities, hospitals and research institutions, can submit applications for research grants directed at the prevention of birth defects. http://www.marchofdimes.com/professionals/691.asp

• National Center for Research Resources (NCRR) directories are available to identify the array of research resource facilities, biomaterials, and models available to biomedical investigators across the country. Funding subsections of this Web site include; Clinical Research supports institutional Research Resources for clinical investigation of human health problems to increase our knowledge of the etiology, progression, prevention, control, and cure of human disease. The Comparative Medicine (CM) area of the NIH National Center for Research Resources helps meet the needs of biomedical researchers for high quality, disease-free animals and specialized animal research facilities. Biomedical Technology supports research, development and access to sophisticated technologies at resource centers nationwide. This area also funds grants for acquisition of state-of-the art shared instrumentation. http://www.ncrr.nih.gov/research_funding/


• National Institutes of Health is the lead federal agency in supporting biomedical research. This link will direct you to a portal for National Institute of Health funding opportunities, including NIH grant and fellowship programs; Requests for Proposals; and resources for those preparing proposals. http://grants.nih.gov/grants/

• Robert Wood Johnson Foundation, has is an extensive list of those making grants in the areas of end of life related areas. http://www.rwjf.org/grants/

• Sponsored Programs Information Network (SPIN), is an internet-accessible database service offered by InfoEd. From this site you can search on several variables for funding sources. http://www.infoed.org/new_spin/spinmain.asp

Questions ?