Sara Brand

Associate Director

Research Compliance Administration

Communicate recent changes in policies and procedures from recent AAHRPP re-accreditationDetailed Self-AssessmentAccreditation Site Visit in December 2007Report from Self-Assessment and Site Visit

Necessitated ChangesAccreditation Council meets in March 2008 to

decide outcome

NOTE: This is not a detailed explanation of how the changes will be implemented

New policies and procedures and forms posted on website March 2008

Standard Operating ProceduresMeeting Deadlines

Fridays @ 5:00pmNew Forms

Request Forms for Vulnerable PopulationsContinuing Review FormsNoncompliance Reporting FormIND/IDE Checklists

Human Subjects Research EngagementExamples and Requirements

Section III: Performance Sites III.B – List other facilities where research-related

procedures will be performed (pharmacy, nursing, pathology, etc.) and ensure these entities are adequately informed

Section IV: Subject PopulationQuestions specific to each subject population

removed and included on new request forms“Reasonable expectation of enrollment”

Section VIII: Protection ProceduresClarification re: information the IRB wants to see if

IUPUI is the lead site of a multi-site studySection IX: Data Safety Monitoring Plan

Checkbox for repository/database protocols

Section X: Confidentiality & SafeguardsStudy Manager (data recording/collection method

and measure for safeguarding information)Section XIV: Informed Consent Process

Questions added re: who and how informed consent will be obtained (training, consent interview and consent document language)

Checkboxes for describing steps to minimize possible coercion or undue influence

Clarification re: waivers of informed consent and modifications to consent document

Financial Conflict of Interest section removedSection XX: Investigational Drugs/Devices

Clarification re: when IND or IDE is required

New Request FormsPrisoners, Children, Pregnant Women, Cognitively

ImpairedVA Requirements

No research involving prisoners, pregnant women, or children unless waiver granted by the Chief R&D Officer

Additional questions/requirements re: surrogate consent for incompetent individuals and individuals with impaired decision-making capacity

Research Involving ChildrenAssent/Waiver of Assent: some, all, or no childrenParental Permission/Waiver of Parental PermissionPolicy when a child reaches the legal age of consent

Guidance re: when IND or IDE is requiredIND and IDE Checklists

Guidance when investigator is the holder of the IND or IDE (i.e. sponsor)Formal face-to-face presentationEventual on-line presentation

Validation of IND or IDE NumberSponsor protocol; orCommunication from FDA

RegulationsUnanticipated Problems (45 CFR 46.103(b)(5)

& 21 CFR 56.106(b))Adverse Events (21 CFR 312.32 & 21 CFR

812.3)Guidance

OHRP (Jan 15 2007)FDA (Apr 2007) – Draft

For more info…

OHRP Guidance: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.pdf

FDA Guidance: http://www.fda.gov/cber/gdlns/advreport.pdf

IUPUI/Clarian Policy for Prompt Reporting of UPsAdverse Events: Unexpected, related, greater

risk of harm, revision to protocol/ICOther UPs: Major Protocol Deviations,

Suspensions or HoldsReport on Prompt Reporting FormReport within (5) business days (both internal

and external)If IRB determines internal event represents

UP, report to federal agencies (OHRP, FDA) and other entities, as applicable

IUPUI/Clarian Policy on Prompt Reporting of NoncomplianceReport all noncomplianceReport on Noncompliance Reporting FormReport with (5) business daysIf IRB determines noncompliance to be serious

or continuing, report to federal agencies (OHRP, FDA) and other entities, as applicable

Continuing ReviewStudy not reviewed by expiration date….automatically

suspendedList of subjects given to IRB and COS at VA to

determine if research can continue on current subjectsDetermine Level of Risk

Based on level of risk, IRB determines when patient medical records should be flagged re: participation in research

Minutes will reflect this decisionEnrollment of Non-Veterans

JustificationRegulations pertaining to veterans in research also

pertain to non-veterans enrolled in VA research

Waiver of Consent for Planned Emergency Research is prohibited at the VA

Waiver of Authorization/Informed Consent for RecruitmentOffice of Research Oversight (ORO) Guidance

(10/09/2007)Accessing patient records for recruitment into

research requires the IRB to approve waivers of authorization and informed consent for recruitment (even when accessing own patients’ records

Questions?Questions?