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Alternate Rights

Lab Animal volume 52, pages 139–140 (2023)Cite this article

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“Alternates” were introduced and supported by both OLAW and USDA in NOT-OD-01-017 (2001)1 and again in NOT-OD-11-053 (2011)2 as part of a larger effort by NIH to reduce regulatory burden on IACUCs and researchers by helping IACUCs conduct business “more efficiently”. The provision of alternates helps IACUCs meet quorum requirements necessary to conduct official business at convened meetings and to perform other IACUC functions when one or more regular IACUC members may not be available to participate. This scenario highlights the importance of establishing IACUC guidelines and policies that clarify and define how the IACUC operates in situations where regulations may be silent, including, when an alternate member can serve in place of their “primary” (full-voting) member or be called upon to perform duties that do not require a vote (e.g., DMR, semi-annual reviews and facility inspections, etc.).

Since DMR is GEU’s default protocol review process, we will assume that at a minimum, GEU IACUC members were provided the name of Guaio’s protocol, a description of the research upon request, and an opportunity to request FCR. In the absence of a request, Crick exercised the Chair’s authority to designate one or more qualified IACUC members to conduct the review on the IACUC’s behalf. Since all IACUC members are equally trained, Crick designated IACUC member, Kahalili, an alternate scientific member. While Guaio is correct that the regulations3 (and PHS Policy4) are silent on “alternate” IACUC members, he is incorrect in asserting that Kahalili is not an IACUC member; both “primary” members and “alternates” must be appointed to the IACUC by the Institutional Official (IO), and alternates may serve in place of one or multiple IACUC members who meet the same IACUC membership requirements.

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References

  1. NIH. Office of extramural research guidance regarding administrative IACUC issues and efforts to reduce regulatory burden. Notice NOT-OD-01-017, Release Date: February 12, 2001, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-017.html

  2. NIH. Guidance to reduce regulatory burden for IACUC administration regarding alternate members and approval dates. Notice NOT-OD-11-053, Release Date: March 18, 2011, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-053.html

  3. Animal Welfare Act regulations. 9 CFR. Chapter I, Subchapter A.

  4. Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals. (U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 2015).

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Authors and Affiliations

  1. Flight IACUC Chair, NASA Headquarters, Washington, D.C., USA

    Mary Lou James

  2. IACUC Chair, NASA Ames Research Center, Moffett Field, Mountain View, CA, USA

    Laura Lewis

Authors
  1. Mary Lou James
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  2. Laura Lewis
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Correspondence to Mary Lou James or Laura Lewis.

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James, M.L., Lewis, L. Alternate Rights. Lab Anim 52, 139–140 (2023). https://doi.org/10.1038/s41684-023-01198-x

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