UAMS Human Research Advisory Committee
SUBJECT: Meeting Minutes
The HRAC office will prepare minutes of each meeting of the HRAC, during which research projects are being reviewed.
Minutes from the prior meeting are mailed with the next agenda for HRAC
members and alternates to review.
Any corrections/comments to the minutes are noted in the minutes of the
next meeting. The minutes are
considered final following these corrections. A copy of the final minutes is filed
chronologically in the HRAC office, and sent to HRAC committee members, the VA
R&D office, and the office of the Vice Chancellor for Academic Affairs and
Sponsored Research at UAMS.
The minutes shall be
retained in the HRAC office for at least 3 years and accessible for inspection
and copying by authorized representatives of the sponsoring Department or
Agency at reasonable times and in a
reasonable manner [45CFR46.115(b)].
The minutes of all
HRAC Committee meetings must be in sufficient detail to show attendance at the
meetings [45 CFR46.115(a)(2); 38
there is a consultant or guest attending
an alternate is voting
a member leaves the room
a member absents themselves during the vote due to a conflicting interest
and continued presence of a majority of members, including at least one
nonscientist member [45 CFR46.108(b)]
For each protocol discussed, the minutes document the
1. The HRAC protocol number and title
2. Actions taken by the
HRAC Committee [45 CFR46.115(a)(2)]
vote on these actions including the number of members voting for, against, and
abstaining [45 CFR46.115(a)(2)]
order to document the continued existence of a quorum, votes should be recorded
in the minutes using the following format: Total = 15; Vote: For-14, Opposed-0,
3. When a protocol
is approved, the minutes should reflect that the HRAC Committee determined:
the risks to subjects are minimized and reasonable in relation to the
anticipated benefits [45 CFR46.111(a)(1,2)]
the selection of subjects is equitable, with particular consideration for
problems that may occur with vulnerable populations [45CFR46.111(a)(3)]
informed consent is appropriately documented (see
HRAC policy 15.1) [45CFR46.111(a)(4,5)]
4. That there are:
a. Provisions for safety monitoring of the data [45CFR46111(a)(6)]
to ensure the privacy of subjects and confidentiality of data [45
c. Appropriate safeguards for vulnerable populations [45CFR46.111b]
protocol revisions are requested or a proposal is disapproved, the basis for
written summary of the discussion of controverted issues and their resolution
determination on the length of time between continuing reviews.
a protocol is under continuing review, the minutes document the following:
number of subjects accrued
description of any adverse events or unanticipated problems involving risks to
subjects or others; withdrawal of subjects from the research; or complaints
about the research
summary of any recent literature, findings, or other relevant information,
especially information about risks associated with the research
d. A copy of the current informed consent document
When specific findings on the part of the HRAC Committee are required
these findings should be fully documented in the HRAC Committee minutes and
should include protocol-specific information justifying each HRAC finding. For example:
Waiver of Informed Consent.
approving a procedure, which alters or waives the requirements for informed
consent, the minutes must document that the Committee made the findings
according to federal regulations (see
HRAC policy 15.3) [45 CFR46.116(c,d].
Prisoners. When approving research involving
prisoners, the minutes must document that the Committee made the seven
additional findings and the
specific category which authorizes the research required (see
HRAC policy 17.9) (45 CFR46.305-306). Additionally, the minutes must reference
that either a majority of the HRAC Committee (exclusive of prisoner members) has
no association with the prison(s) involved, apart from their membership on the
HRAC [45 CFR46.304(a)]; or at least one member of the HRAC Committee is a
prisoner, or a prisoner representative with appropriate background and
experience to serve in that capacity, except that where a particular research
project is reviewed by more than one HRAC only one HRAC need satisfy this
requirement [45 CFR46.304(b)].
Children. When approving research-involving children,
the minutes must document that the Committee made the findings according to FDA
HRAC policy 17.1) (45CFR46.404-407). When reviewing research
involving children who are wards of the state or any other agency, institution,
or entity, the HRAC must find and document in the minutes that such research is:
(1) related to their status as wards; or (2) conducted in schools, camps,
hospitals, institutions, or similar settings in which the majority of children
involved as subjects are not wards.
Alternates. Meeting minutes must document when an alternate Committee member replaces the primary committee member.
When reviewing protocols that request exception for consent in emergency
research, the HRAC Committee meeting minutes must specifically record the
licensed physician memberís affirmative vote (21 CFR50(b); 21 CFR50.2421
CFR50(b); 21 CFR50.24; 45 CFR).