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A Word from the USDA and OLAW

Lab Animal volume 50, page 260 (2021)Cite this article

Subjects

In this scenario, Dr. Silverman’s protocol undergoes Designated Member Review (DMR) followed by Full Committee Review (FCR) and then another DMR. In the process, the protocol is approved by the second DMR but not all concerns raised during the FCR are addressed in the final approved version.

Under the AWA regulations, the decisions that could be made during FCR are approve, require modifications to secure approval, approval withheld1, or suspension of an animal activity2. The IACUC during FCR can agree to send a protocol to DMR. Under the regulations, DMR decisions are approve, require modifications to secure approval, or request FCR3. In this scenario the concerns raised by Dr. Watson about the food restriction were not addressed during the second DMR before approval was given. No details were provided as to why this occurred. As a result, Watson felt the protocol should not have been approved.

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References

  1. 9 C.F.R. § 2.31(c)(6), Institutional Animal Care and Use Committee (IACUC).

  2. 9 C.F.R. § 2.31(d)(6), Institutional Animal Care and Use Committee (IACUC).

  3. 9 C.F.R. § 2.31(d)(2), Institutional Animal Care and Use Committee (IACUC).

  4. 9 C.F.R. § 2.31(c)(3), Institutional Animal Care and Use Committee (IACUC).

  5. Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals. IV.C. (U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 2015). https://olaw.nih.gov/policies-laws/phs-policy.htm#ReviewofPHS-ConductedorSupportedResearchProjects

  6. Office of Laboratory Animal Welfare, National Institutes of Health. Frequently Asked Questions. PHS Policy on Humane Care Use of Laboratory Animals. Protocol Review. Question D.3. What are the possible methods of IACUC approval? https://olaw.nih.gov/faqs#/guidance/faqs?anchor=question50314

  7. Office of Laboratory Animal Welfare, National Institutes of Health. NOT-OD-09-035, Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-035.html

  8. Office of Laboratory Animal Welfare, National Institutes of Health. Frequently Asked Questions. PHS Policy on Humane Care Use of Laboratory Animals. Protocol Review. Question D.19. May an IACUC use designated member review (DMR) to review an animal study protocol subsequent to full committee review (FCR) when modifications are needed to secure approval? https://olaw.nih.gov/faqs#/guidance/faqs?anchor=question50340

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Author information

Authors and Affiliations

  1. Director, Office of Laboratory Animal Welfare, OER, OD, NIH, HHS, Bethesda, MD, USA

    Patricia Brown VMD, MS, DACLAM

  2. Deputy Administrator, Animal Care, APHIS, USDA, Riverdale, MD, USA

    Betty Goldentyer DVM

Authors
  1. Patricia Brown VMD, MS, DACLAM
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  2. Betty Goldentyer DVM
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Corresponding authors

Correspondence to Patricia Brown VMD, MS, DACLAM or Betty Goldentyer DVM.

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Brown, P., Goldentyer, B. A Word from the USDA and OLAW. Lab Anim 50, 260 (2021). https://doi.org/10.1038/s41684-021-00851-7

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