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A Word from OLAW

Lab Animal volume 52, page 76 (2023)Cite this article

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In this scenario, because of noise and vibration from construction adjacent to the vivarium, animals are exhibiting behavioral changes and reduced fecundity impacting ongoing research. The resulting environment does not meet the requirements of the PHS Policy for proper living conditions or the expectations of the Guide for facilities to minimize unnecessary noise and vibration1,2,3. The IACUC, the institution, and the Principal Investigator (PI) must each address the problem. Key functions of the IACUC are to review concerns involving the care of animals, make recommendations to the Institutional Official (IO), and, through the IO, provide OLAW an explanation of the circumstances of any serious or continuing noncompliance with the Policy or serious deviation from the Guide1. To address the unusable data and need for additional animals to complete the study, the IACUC should allow changes to the approved activity, which should resume only when the living conditions comply with the PHS Policy and the Guide’s expectations. The IACUC should also promptly inform the IO of the situation, that reporting to OLAW is indicated and the institution should consider compensation for the lost efforts. The IO, by signing the institution’s Assurance with OLAW, must have the authority to commit institutional resources to meet the requirements of the Policy1,2,4. The PI is required by the NIH Grants Policy Statement to report annually in the Research Performance Progress Report (RPPR) to the NIH funding component. In the RPPR, the PI must report any challenges or delays in the project with plans for resolving them, and significant changes regarding animal subjects5,6. The PI may also contact the NIH Program Official who monitors the grant to discuss the research interruption and its potential impact on the grant7.

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References

  1. 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).

  2. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th edition, p 50, (National Academies Press, Washington, D.C., USA, 2011).

  3. Brown, P. Lab Anim (NY) 49, 270 (2020).

    Article  PubMed  Google Scholar 

  4. Public Health Service Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.5. What is the difference between the Institutional Official and the Chief Executive Officer? (US Department of Health and Human Services, Bethesda, MD, USA). https://olaw.nih.gov/faqs#/guidance/faqs?anchor=50380

  5. National Institutes of Health. NIH Grants Policy Statement, 8.4.1.1 Non-Competing Continuation Progress Reports. (US Department of Health and Human Services, Bethesda, MD, USA). https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm#Non-Comp

  6. National Institutes of Health. Grants & Funding, About Grants, Research Performance Progress Report (RPPR). (US Department of Health and Human Services, Bethesda, MD, USA). https://grants.nih.gov/grants/rppr/index.htm

  7. National Institutes of Health. Grants & Funding, Need Help? Understand Staff Roles, Program Officials. (US Department of Health and Human Services, Bethesda, MD, USA). https://grants.nih.gov/help/ic-staff-roles#program-official

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Authors and Affiliations

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

    Patricia Brown

Authors
  1. Patricia Brown
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Correspondence to Patricia Brown.

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Brown, P. A Word from OLAW. Lab Anim 52, 76 (2023). https://doi.org/10.1038/s41684-023-01146-9

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