IRB: Minutes of IRB Meetings
Policy number:
305
References:
45 CFR 46.115(a)(2); 45 CFR 46.116(c)-(d); 45 CFR 46.117(c); 45 CFR
46.204-207; 45 CFR 46.305, 45 CFR 46.306, 45 CFR 46.404-408;
21 CFR 50.51-56, 21 CFR 56.109(c), 21 CFR 56.115(a)(2),
45 CFR 46 Waiver of the Applicability of Certain Provisions of DHHS
Regulations for Protection of Human Research Subjects for DHHS
Conducted or Supported Epidemiologic Research Involving Prisoners as
Subjects (Federal Register, Vol. 68, No. 119, pp. 36929-36931, Friday,
June 20, 2003)
45 CFR §46 Waiver Of Informed Consent Requirements in Certain
Emergency Research (Federal Register, Vol. 61, No. 192, pp. 5153151533, October 2, 1996)
OHRP Guidance on Written Institutional Review Board (IRB) Procedures;
FDA Info Sheets: FAQ: IRB Records, Significant Risk and Non-Significant
Risk Medical Device Studies
Date: 03/07/2014
Policy Owner:
Executive Director, HRPP
AAHRPP II.5.A and B
Cross Reference:
308 Access to Meetings
Definitions:
None
1.0 Reason for Policy
To describe how the IRB documents the discussions and findings of the convened IRB meetings.
__________________
2.0 Scope of Policy
This policy applies to HRPP staff and IRB members.
3.0 Policy Statement
Minutes are recorded during convened meetings and document pertinent discussions and actions
taken by the IRB on research studies and activities. The minutes template is used to prompt and
document separate deliberation for each protocol undergoing review.
Procedures:
From notes taken during the meeting, HRPP staff prepares minutes clearly reflecting IRB action
on each item reviewed, and the reasons for the action.
Minutes include the following information:
o Date of the meeting
o List of the members and any consultants or guests present in person or by
telephone or ITV. If a guest is in attendance, the guest will sign a confidentiality
statement that will be attached to the minutes.
o Duration of the meeting
o List of any alternates who are seated, and for whom they are serving
o Separate deliberations for each of the following types of reviews: initial review,
continuing review, modifications to approved research projects, and any
unanticipated problems
o Summary of any controverted issues of each protocol or other matter under
review and the resolution of the issue
o Number of votes for, against, or abstaining of each action.
o Description of all requests to be made to principal investigators for modifications
to reviewed protocols or consent forms, and/or additional information including
the actual text transmitted to the investigator. Notation of the IRB findings
enabling the recorded decision (e.g. finding that the specific requirements for
waiver of consent or waiver of documentation are met when recording a decision
to allow such a waiver)
o Required determinations and protocol specific findings justifying those
determinations for waiver and alteration of consent, waiver of consent
documentation, Subparts B, C, D determinations, significant or non-significant
risk devices and research involving participants with diminished capacity to
consent
o Name of reviewer
o Verification of changes in risk for continuing reviews, modifications to reviewed
protocols or consents, and unanticipated problems (unaffected, increased,
decreased)
o The names of IRB members and consultants who abstain from voting or are
absent due to a conflict of interest. Basis for:
 Requiring changes to the research
 Disapproving the research
o Justification for modification of risks or alternative procedures in consent forms
o During initial and continuing review, a determination of review intervals based on
risk
o Protocol specific findings required by local policy and applicable regulation.
o In the event a study was suspended and the IRB votes to lift the suspension,
minutes will reflect the action and vote count.
Items on the agenda are not necessarily reviewed in the order in which they appear.
Minutes are available to IRB committee members on the IRB “members only” section of the
IRB website or by request, irrespective of committee appointment. Final version of the
minutes may not be modified by anyone; addenda may be added for further clarification.
Minutes are retained permanently.
4.0 Required approvals for this document
Title
Executive Director, HRPP
5.0 Revision History
03/07/14
03/30/2012
11/15/11
08/30/2011
01/10/2011
10/05/09
Reason for change
Review & revision
Conf agreement add to minutes
Add suspension action notation
Revision
Revision
Update AAHRPP reference
Date of release
09/02/14
03/30/2012
11/15/11
08/30/2011
01/10/2011
10/05/09
05/13/09
Reformatted
06/05/09
Revision
12/08/06
To obtain a copy of a historical policy, e-mail irb@umn.edu or call 612-626-5654