Guidance to Reduce
Regulatory Burden for IACUC Administration Regarding Alternate Members and
Notice Number: NOT-OD-11-053
Date: March 18, 2011
Office of Extramural Research Guidance Regarding Administrative IACUC Issues
and Efforts to Reduce Regulatory Burden
NOT-OD-09-035: Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR)
National Institutes of Health (NIH)
This notice provides guidance to Public Health Service (PHS)
awardee institutions and Institutional Animal Care and Use Committees (IACUCs)
concerning the following two administrative IACUC issues: use of alternate
IACUC members and date of IACUC approval.
The Office of Laboratory Animal Welfare (OLAW), NIH, the
USDA Animal and Plant Health Inspection Service (APHIS) and the Food and Drug
Administration operate under a Memorandum of Understanding (MOU) that provides for enhanced communication and allows common concerns of
the agencies to be managed in a consistent manner in spite of differing
statutory or regulatory mandates. The MOU ensures that the differing approaches
of the agencies are harmonized without unnecessarily increasing regulatory
burden. As a result of ongoing discussions about administrative issues dealing
with the ways that IACUCs function and efforts by IACUCs to conduct business
more efficiently, OLAW is issuing the following guidance. The purpose of the
guidance is to ensure that IACUC policies and procedures are in accordance with
Policy on Humane Care and Use of Laboratory Animals (Policy) and, as
applicable, the USDA Animal Welfare Regulations (AWRs). The USDA Animal and
Plant Health Inspection Service (APHIS) has reviewed and concurs with the
guidance provided in this notice.
Use of Alternate IACUC Members
Service by alternate IACUC members offers an effective
management practice to ensure timely review and approval of animal activities.
This guidance by OLAW and APHIS updates the provisions for the use of
alternates from 2001 guidance [NOT-OD-01-017].
Although PHS Policy and the USDA AWRs are silent on the use
of alternate IACUC members, OLAW and APHIS agree that alternates may be
utilized if the following provisions are met:
The Chief Executive Officer, or designee, must appoint alternates
to the IACUC in writing. Appointment of the IACUC is described in the PHS
Policy at IV.A.3.a and the AWRs at 2.31(b). This procedure applies to appointment of both regular
members and alternates.
Alternates may only serve as an alternate in the membership
category(s) for which they are qualified. Membership categories are described
in the PHS Policy at IV.A.3.b and the AWRs at 2.31(b). The specific name(s) of the regular member(s) for whom
the alternate serves are not required in the appointment letter.
If the regular member fulfills a specific membership requirement,
his or her alternate must also fulfill that requirement. If the regular member
fulfills more than one membership requirement, the alternate must meet the same
- One alternate may be appointed to serve for multiple regular
members provided the alternate fulfills the specific membership requirement of
the members for whom he or she is substituting. However, an alternate may not
represent more than one member at any one time.
- Multiple alternates may be appointed to represent one regular
IACUCs must be properly constituted to conduct official business.
- An IACUC member and his/her alternate may not contribute to a
quorum at the same time or act in an official IACUC capacity at the same time.
- An alternate may only contribute to a quorum and function as an
IACUC member if the regular member for whom they serve as alternate is
unavailable to participate in IACUC business, whether it is because that member
is unable to attend the meeting, has to leave the meeting early or arrive late,
or is recused from participating due to a real or potential conflict of
Alternate members are expected to vote their conscience and not
represent the position of the regular member for whom they serve.
- Alternate members are permitted and encouraged to attend IACUC
meetings and other IACUC activities even when the regular member is present.
- Alternates should receive IACUC training and orientation
identical to that which is provided to regular members.
- Alternates must be listed as alternates on the IACUC roster
submitted to OLAW as part of the Animal Welfare Assurance and annual reports.
Institutions may, at their discretion, represent the names of alternates by
using numbers or other symbols in submissions to OLAW. Sufficient information
for OLAW to determine that alternates are appropriately qualified must be
provided including the alternate’s degree(s)/credentials, position title, and
membership category as described in the PHS Policy at IV.A.3.b.
The identity of alternates must be readily ascertainable by the institution and
available to authorized OLAW or other PHS representatives upon request.
Date of IACUC Approval
The PHS Policy and USDA AWRs are silent regarding the date
of approval of an animal activity. OLAW and APHIS offer the following guidance
on this topic. The date of approval is the date that appears in the written
notification of approval to the principal investigator. IACUCs have flexibility
to develop a system that functions well for their institution, provided that
the approval date occurs within a reasonable period of time after review and
approval [see AWR 2.31(d), PHS Policy IV.C.].
For example, the IACUC may designate an approval date as the last working day
of the month in which the proposal was reviewed, allowing time to make minor
corrections or confirm other activities which may affect the approval (e.g.,
safety committee review, research staff training).
For questions or further information, contact:
Office of Laboratory Animal Welfare
National Institutes of Health