IRB Minutes Karen Jeans MSN CCRN CIP COACH

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

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

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)

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

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

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

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

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

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 decisionmaking capacity • What about Flagging of Patient’s Medical Records? • Source: VHA Handbook 1200. 05

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.

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

AAHRPP • Nuances • Justification of any deletion or substantive • modifications of information concerning risks or alternative procedures contained in the DHHSapproved 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)

Issue with IRB Minutes • Balancing Act between too much or too little