It is clear that Great Eastern University is following valid methods of IACUC review as allowed by PHS Policy which are: “(1) full-committee review by a convened quorum of members of the IACUC. Or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review”1. The question is whether an alternate member of the IACUC has the authority to call for FCR at a time when it is unclear whether he/she is acting as a voting member. OLAW guidance clarifies that “An IACUC member and his/her alternate may not contribute to a quorum at the same time or act in an official IACUC member capacity at the same time. An alternative member may only contribute to a quorum and function as an IACUC member if the regular member for whom they serve as alternate is unavailable”2.
The Great Eastern University IACUC Chair admitted that they did not have a process in place to identify when alternate members would be acting as voting members during the 72 hour review window. We believe that if all voting members were available for review, then the alternate member did not have the authority to request FCR. With that being said, however, we also believe that the Great Eastern University IACUC should encourage full participation by both alternate and voting members, and they were fully justified in providing an FCR of the protocol at the convened meeting. To do otherwise may impose additional administrative burden and further delay the committee's decision. Moreover, the IACUC is tasked with overseeing the institution's animal program, and if any member has a concern, they should discuss it with the committee.
In the future, the Great Eastern University IACUC should consider adopting a written policy that clearly delineates which members can request FCR. They should also find a method whereby voting members who are unavailable for the 72 hour review are identified, so that alternate members can act in an official IACUC member capacity allowing them to request FCR.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986, revised 2015).
National Institutes of Health. NOT-01-017: Guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. National Institutes of Health Office of Extramural Research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-017.html
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Saunders, K., Dale, W. Response to Protocol Review Scenario: No harm done, but they can do better. Lab Anim 46, 88 (2017). https://doi.org/10.1038/laban.1234
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DOI: https://doi.org/10.1038/laban.1234
