1. IRB Minutes Karen Jeans, MSN, CCRN, CIP COACH Program Analyst

2. Objectives Quantify and qualify IRB minutes requirements VA requirements AAHRPP accreditation standards DHHS regulations FDA regulations

3. What is required vs. suggested to be documented in IRB minutes Common Rule Attendance Actions taken by the IRB Vote on the actions Basis for requiring changes in disapproving research Written summary of discussion of controverted issues Source: 38 CFR 16.115(a)(2)

4. Attendance Document attendance Members Others Entry/Exit/Recusals Document quorum Loss of quorum = no further action

5. IRB Actions and Votes Minutes to reflect actions taken by convened IRB Regulatory Vote on IRB Actions For Against Abstaining

6. Basis for Requiring Changes in or Disapproving Research Why IRB required changes to specific proposed research Why IRB disapproved research

7. Controverted Issues Written summary Discussion Resolution Dictionary definition of controverted: To dispute or opposed by reasoning To engage in controversy

8. Why aren’t minutes consistent from one IRB to another? Subjective component Robert’s Rules of Order Varying interpretations of Attendance Actions Votes Basis for requiring changes in or disapproving research Controverted issues

9. What is required vs. suggested to be documented in IRB minutes VA Determination of level of risk if not recorded elsewhere in IRB records Frequency of continuing review of each proposal as determined by the IRB is not recorded elsewhere in IRB records Review of additional safeguards to protect vulnerable populations if entered as study subjects when this is not otherwise documented in IRB records Pregnant women Prisoners Children Mentally disabled persons or those persons with impaired decision- making capacity What about Flagging of Patient’s Medical Records? Source: VHA Handbook 1200.05

10. VA Guidance Usual Care Interim Guidance on Protecting the Rights and Welfare of Human Subjects in Research Involving Usual Care (October 10, 2008) Should an IRB question a protocol’s characterization of “usual care” or its associated risks, the IRB should seek clarification from the investigator and, if warranted, from qualified experts and document its determinations accordingly.

11. VA Guidance Vulnerable Subjects Interim Guidance on Research Warranting Special Safeguards to Protect the Rights and Welfare of Human Subjects (October 10, 2008) IRBs should, where relevant, include documentation that adequate safeguards have been included to protect the rights and welfare of subjects who are likely to be susceptible to coercion or undue influence

12. AAHRPP Nuances Justification of any deletion or substantive modifications of information concerning risks or alternative procedures contained in the DHHS- approved sample consent document Names of IRB members who leave the meeting because of a conflicting interest along with the fact that a conflicting interest is the reason for the absence Source: AAHRPP Evaluation Instrument for Accreditation for VA Facilities and Academic Affiliates (Updated June 1, 2007)

13. Issue with IRB Minutes Balancing Act between too much or too little