In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:
Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR)1 was published in response to questions from IACUCs regarding allowable procedures when a protocol that has been considered at a convened meeting cannot be approved as written. Their questions focused on ways that IACUCs could use DMR as a follow-up to FCR when a protocol lacks substantive information.
Regarding the term “substantive information” in the context of proposals involving animal-related activities, IACUCs are required to evaluate proposals to ensure that they meet the following criteria: (i) conform with the institution's Animal Welfare Assurance and meet the requirements specified in the Public Health Service (PHS) Policy at IV.C.1 (ref. 2); (ii) provide the information described in the Policy at IV.D.1 (ref. 2); (iii) adhere to provisions of the Guide for the Care and Use of Laboratory Animals3; and (iv) as appropriate, are consistent with the USDA's Animal Welfare Regulations4.
Should a proposal fail to address any of these items to the IACUC's satisfaction, the Committee may determine that the proposal lacks substantive information and require modifications to secure its approval.
OLAW and USDA note that if a protocol 'requires modifications to secure approval', then investigators must consider IACUC concerns (some of which may be expressed as questions) and address them to the Committee's satisfaction. It does not mean that IACUCs are authorized to dictate specific research methods in a protocol; for example, an IACUC should not require an investigator to use a specific analgesic, but rather should work with the investigator to ensure the animals are provided adequate pain relief5. Also, there are no provisions in the PHS Policy or the Animal Welfare Act for approval of proposals based on investigator responses to IACUC “questions.”
Therefore, although the example in the scenario about inadequate justification for the number of animals requested may raise serious questions, it also represents a lack of substantive information that must be resolved by requiring an appropriate modification to the protocol from the investigator. There are no PHS Policy or AWA provisions for administrative acceptance (i.e., approval) of proposals.
References
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
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals (National Academies Press, Washington, DC, 1996).
Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare: Part 2 Regulations. [§2.31(d)].
U.S. Public Law 99-198 (1985), The Improved Standards for Laboratory Animals Act, Food Security Act of 1985, Subtitle F – Animal Welfare, [7 U.S. Code, Section 2143(a)(6)].
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Protocol Review, Question No. 19. (US Department of Health and Human Services, Washington, DC, 2006, revised 2009). http://grants.nih.gov/grants/olaw/faqs.htm#proto_19.
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 38, 227 (2009). https://doi.org/10.1038/laban0709-227
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DOI: https://doi.org/10.1038/laban0709-227