IRB Minutes

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 arent minutes consistent from one IRB to
another?

• Subjective component
• Roberts 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 Patients 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 protocols
  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