In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:
For animal activities funded by the Public Health Service (PHS), the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy; section IV.B.4) states that the “IACUC shall review concerns involving the care and use of animals at the institution”1. Similarly, for species covered by the Animal Welfare Act, “The IACUC shall... review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees”2. Neither the PHS Policy nor the Animal Welfare Act Regulations limits how or when such concerns are considered. In this scenario, the IACUC member has a serious concern about the lack of analgesia for a proposed surgical procedure in a research protocol in the midst of review by a designated member of the committee. As mentioned by several of the respondents, OLAW's guidance on the use of Designated Member Review (DMR) subsequent to Full Committee Review (FCR) states that “any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol”3. OLAW's guidance is in accordance with USDA's regulation on designated member review2. The guidance can and should be interpreted broadly to apply to this particular scenario and to other circumstances where an IACUC member has concerns about a research protocol already approved by the committee or in the process of review and approval by either DMR or FCR. Administrative practices of the committee should not impede the appropriate and thorough review of concerns about proposed or ongoing animal activities. Critical to this issue is clear communication among the IACUC, the veterinarian and investigators to resolve questions and concerns about a protocol at the earliest point.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Code of Federal Regulations. Title 9, Chapter 1, Subchapter A – Animal Welfare: Part 2 Regulations (§2.31).
Office of Laboratory Animal Welfare. Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR). Notice NOT-OD-09-035. (National Institutes of Health, Washington, DC, 8 January 2009). http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-035.html
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 40, 12 (2011). https://doi.org/10.1038/laban0111-12a
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DOI: https://doi.org/10.1038/laban0111-12a
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