In response to the questions posed 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 guidance:
The scenario describes an IACUC policy to reuse the same reviewer for protocol modifications that had been previously assigned as either primary reviewer for full committee review (FCR) or designated reviewer for designated member review (DMR). The scenario considers whether the policy is compliant with the Animal Welfare Act and regulations (AWARs) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The AWARs and the PHS Policy have similar requirements regarding the review of protocols or amendments. Any member can request a FCR, but if FCR is not requested, at least one member can conduct a DMR. This member is appointed by the IACUC chairperson and qualified to conduct the review. The only decisions arising from a DMR are to approve, to require modifications (to secure approval) or to request FCR1,2.
Although it may be a common practice, assigning a primary reviewer to present a protocol during FCR is not described in the AWARs or the PHS Policy. The IACUC has flexibility to use such a practice and may consider the continued service of this reviewer for continuity both when significant changes to the approved protocol are requested and if DMR subsequent to FCR is needed to address IACUC-required modifications. There are a variety of ways to have the reviewer for DMR designated by the chairperson, including creating a policy such as the one described. Use of a rotational list of reviewers approved by the chairperson and based on identified expertise is another practice to improve efficiency of the appointment. The policy should allow for necessary changes to a future assignment created by a conflict of interest or unavailability while ensuring that the member assigned is qualified to conduct the review. Appointment of a vice chairperson to assign reviewers in the chairperson's absence is another mechanism to increase efficiency.
References
Animal Welfare Act Regulations. 9 CFR §2.31(d)(2)
Public Health Service. Policy on Humane Care and Use of Laboratory Animals IV, C, 2 (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 44, 340 (2015). https://doi.org/10.1038/laban.845
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DOI: https://doi.org/10.1038/laban.845
