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A Word from USDA and OLAW

Lab Animal volume 52, page 217 (2023)Cite this article

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The Animal Welfare Regulations (AWRs) define primary investigator as the person “responsible for a proposal to conduct research and for the design and implementation of research involving animals1.” As the named PI, Dr. Felelős retains responsibility for implementing the research activities approved by the IACUC, regardless of his choice to delegate oversight authority. However, the research facility is ultimately responsible for ensuring compliance with the AWRs2. The IACUC, as an agent of the research facility, is required to review and approve significant changes regarding the care and use of animals in ongoing activities3, and Dr. Abigail’s decision to exceed IACUC-approved humane endpoints represents a critical non-compliance4. Furthermore, the IACUC is empowered to suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the PI and approved by the Committee5,6. Accordingly, the IACUC’s actions in this scenario are consistent with the AWRs.

NIH and other federal agencies who abide by the PHS Policy hold the PI responsible not only for the scientific and technical aspects of a grant or contract award, but also for ensuring compliance with the PHS Policy when using live vertebrate animals7,8,9. Likewise, the Guide addresses PI responsibilities in multiple areas including humane endpoints, and occupational health and safety10. The PI retains these responsibilities even when delegating aspects of the research oversight to a team member.

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References

  1. Animal Welfare Regulations. 9 CFR § 1.1.

  2. Animal Welfare Regulations. 9 CFR §2.30(b).

  3. Animal Welfare Regulations. 9 CFR § 2.31(c)(7).

  4. United States Department of Agriculture. [Internet]. 2023. Animal Welfare Inspection Guide. https://www.aphis.usda.gov/animal_welfare/downloads/Animal-Care-Inspection-Guide.pdf

  5. Animal Welfare Regulations. 9 CFR § 2.31(c)(8).

  6. Animal Welfare Regulations. 9 CFR § 2.31(d)(6).

  7. NIH Grants Policy Statement. 2.3.7.6 Program Director/Principal Investigator, Individual Fellowship and Sponsor Assurance. Revised December 2022. [online] https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.7_policies_affecting_applications.htm#Program

  8. U.S. Department of Health and Human Services, National Institutes of Health, Office of Laboratory Animal Welfare. What Investigators Need to Know About the Use of Animals. NIH Publication No. 16-OD-6009. Revised April 2016. [online] https://olaw.nih.gov/sites/default/files/InvestigatorsNeed2Know.pdf

  9. National Institutes of Health. Office of Extramural Research. Grants Policy and Guidance, Frequently Asked Questions, Multiple Principal Investigators, A. General Questions, number 1. https://grants.nih.gov/faqs#/multiple-principal-investigators.htm?anchor=52628

  10. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th edition, (National Academies Press, Washington, D.C., USA, 2011). pp 27-28,32.

  11. Public Health Service Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Protocol Review, Question No. D.18. Is it acceptable to have different individuals named as PI on the grant application and the IACUC protocol? (US Department of Health and Human Services, Bethesda, MD, USA). https://olaw.nih.gov/faqs#/guidance/faqs?anchor=50333

  12. 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

  13. Office of Laboratory Animal Welfare, National Institutes of Health. Public Health Service Policy on Humane Care and Use of Laboratory Animals. (US Department of Health and Human Services, Bethesda, Maryland, USA, 2015). IV.B.8 and IV.C.6

  14. Juarez, B. & Brown, P. Lab Anim (NY) 47, 172 (2018).

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Authors and Affiliations

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

    Patricia Brown

  2. Senior Veterinary Medical Officer – Research, Animal Care National Policy Staff, APHIS, USDA, Riverdale, MD, USA

    Louis DiVincenti

Authors
  1. Patricia Brown
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  2. Louis DiVincenti
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Correspondence to Patricia Brown or Louis DiVincenti.

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Brown, P., DiVincenti, L. A Word from USDA and OLAW. Lab Anim 52, 217 (2023). https://doi.org/10.1038/s41684-023-01253-7

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