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A Word from OLAW and USDA

Lab Animal volume 52, page 171 (2023)Cite this article

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By extending the IACUC’s oversight using qualified and trained individuals to conduct quality assurance (QA) reviews, Great Eastern University (GEU) has begun a creditable post-approval monitoring (PAM) program to ensure compliance with the protocols that the IACUC approved1. PHS Policy Footnote 8 supports this use of PAM and allows flexibility in the size and scope of how IACUC oversight is implemented provided that the IACUC remains responsible for the evaluation and the report to the Institutional Official2.

The disconnect in this PAM program is 1) the delay in reporting findings of noncompliance to the IACUC, 2) coordination of the reporting with the IACUC’s subsequent evaluation and corrective actions, and 3) prompt reporting of any noncompliance to OLAW3,4. The two examples involving use of euthanasia methods not included in the approved protocols are failures “to adhere to IACUC-approved protocols” and require prompt reporting to OLAW3,4. Likewise, because of GEU’s policy requiring a list of animal activity locations in the protocol, the use of a different location deviates from the approved protocol and is reportable to OLAW4. Finding incomplete or inaccurate post-operative surgical records is reportable to OLAW due to the “failure to maintain appropriate animal-related records4.” If in doubt about whether a situation requires reporting, institutions with an Animal Welfare Assurance should consult with OLAW4.

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References

  1. Public Health Service Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.6. Is post approval monitoring required? (US Department of Health and Human Services, Bethesda, MD, USA). https://olaw.nih.gov/faqs#/guidance/faqs?anchor=50381

  2. 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). FOOTNOTES, Footnote 8. https://olaw.nih.gov/policies-laws/phs-policy.htm#FOOTNOTES

  3. 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). Section IV.F.3. Reporting Requirements. https://olaw.nih.gov/policies-laws/phs-policy.htm#ReportingRequirements

  4. National Institutes of Health. Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals. Notice NOT-OD-05-034 [online]. (National Institutes of Health, Bethesda, MD, 24 February 2005). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html

  5. United States Department of Agriculture. Animal Welfare Inspection Guide [online]. (United States Department of Agriculture, Riverdale, MD, December 2022). https://www.aphis.usda.gov/animal_welfare/downloads/Animal-Care-Inspection-Guide.pdf

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Authors and Affiliations

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

    Patricia Brown

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

    Roxanne Mullaney

Authors
  1. Patricia Brown
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  2. Roxanne Mullaney
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Corresponding authors

Correspondence to Patricia Brown or Roxanne Mullaney.

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Brown, P., Mullaney, R. A Word from OLAW and USDA. Lab Anim 52, 171 (2023). https://doi.org/10.1038/s41684-023-01218-w

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