Human Research Protection Program: Policy

IRB Minutes

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

Purpose:  This document describes what information the UW-Madison IRBs include in IRB meeting minutes.

Policy

I.  UW-Madison IRB minutes include documentation of:

A.  Deliberations, actions and votes for all protocols undergoing:

 

1.  Initial review.

 

2.  Continuing review.

 

3.  Change of protocol review.

B.  Actions taken by the IRB.

C.  Votes on actions including the number of members voting for, against, and abstaining.

D.  The names of IRB members who:

 

1.  Abstain from voting.

 

2.  Absent themselves from the meeting due to a conflict of interest.

E.  Attendance at the meeting.

 

1.  IRB staff monitors and records the arrivals and departures of IRB members as they occur throughout each scheduled meeting.

 

2.  IRB staff monitors and documents when an alternate member replaces a primary member.

 

3.  IRB staff monitors and documents attendance of members or alternate members who participate through videoconference or teleconference

F.  The basis for:

 

1.  Requiring changes in research.

 

2.  Disapproving research.

G. A written summary of the discussion of controverted issues and their resolution.

H.  For initial and continuing review, the degree of risk and the approval period (review interval), to reflect the determination of which protocols require continuing review more often than annually, as appropriate to the degree of risk.

I.   Determinations required by applicable regulations and protocol specific findings justifying those determinations for:

 

1.  Waiver or alteration of informed consent.

 

2.  Waiver of consent documentation.

 

3.  Research involving pregnant women, human fetuses and neonates.

 

4.  Research involving prisoners.

 

5.  Research involving children.

J.  Determinations required by applicable regulations and institutional policy for full or partial waiver or alteration of a signed HIPAA Authorization for the research use of protected health information

K.  In FDA-regulated medical device trials, the rationale for Significant Risk/Non-Significant Risk determinations and subsequent approval or disapproval decisions for the clinical investigation.

L.  If outside expert review was required, this should be noted and the expertise of the reviewer and his/her comments cited.

M. For Department of Veterans Affairs (VA) research protocols, the minutes must document that:

 

1.  the VA representative was present for the vote.

 

2.  attendance of members or alternate members who participated through videoconference or teleconference

 

3.  members or alternate members who participated through videoconference or teleconference received all pertinent material before the meeting and were able to actively and equally participate in all discussions.

 

4.  The approval of research contingent on specific minor conditions by the chair or designee, to be documented in the minutes of the first IRB meeting that took place after the date of the approval.

 

5.  The determination of the level of risk.

N. The IRB provides meeting minutes for IRBs reviewing VA protocols to the Research and Development Committee. The IRBs wrote minutes and made them available for review within three weeks of the meeting date.