Release 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 the PHS 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.
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 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).
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