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A Word from OLAW and USDA

Lab Animal volume 52, page 191 (2023)Cite this article

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There are several concerns arising from the Principal Investigator’s decision to use rabbits from a variety of sources and consider the animals comparable. One concern is whether the research protocol that the IACUC approved described the varied genetic backgrounds of the rabbits. If animals with a transgenic background were not described in the approved protocol, then a failure to adhere to the protocol has occurred and is reportable to OLAW1. Another concern is the unauthorized transfer of transgenic animals to other investigators without IACUC or IBC approval. This circumstance requires investigation by both committees, corrective actions to prevent recurrence acceptable to the IACUC and IBC, and reporting to OLAW and the National Institutes of Health (NIH), Office of Science Policy1,2. If the findings are found to be programmatic, corrective approaches applicable to all laboratories may be required. Revisions to policies, standard operating procedures, IACUC and IBC forms, and training may be necessary. Assuming the study was NIH-funded, of concern is the lack of uniformity in the research design that compromises the rigor of the study. Since 2019, NIH has required grant applicants to describe in the Approach section of the Research Strategy how the experimental design and methods proposed will achieve robust and unbiased results3. To assist applicants, NIH provides guidance on how to address rigor and reproducibility in the application, explains how the application will be evaluated for scientific merit, and provides application preparation resources including links to a free online tool for designing animal experiments4,5.

The Animal Welfare Regulations require a proposal to conduct an activity involving animals to contain “a complete description of the proposed use of the animals6”. This complete description should include information regarding the acquisition and disposition of the animals. The IACUC should have closely reviewed Dr. Virale’s plan for disposition of transgenic offspring that do not carry of the gene of interest since this is an expected outcome when breeding transgenic animals. Before Dr. Virale used an alternate disposition method (e.g., transfer the animals to a different research protocol), the IACUC is required to review and approve such a significant change in ongoing activities7. Similarly, Dr. Guaio’s protocol should have described acquisition of animals, and acquiring animals from a different source than is listed in the protocol requires IACUC review and approval. Additionally, although the regulations are silent regarding subspecies and transgenics, the regulations do require proposals to include a rationale for involving animals, and for the appropriateness of the species8. Dr. Guaio failed to consider the appropriateness of the animals he received from Dr. Virale, which resulted in potentially unnecessary animal pain and distress and a poor scientific outcome.

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References

  1. 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

  2. Department of Health and Human Services, National Institutes of Health. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines, April 2019). https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf

  3. National Institutes of Health. NIH Grants & Funding, Policy & Compliance. Enhancing Reproducibility through Rigor and Transparency [online]. https://grants.nih.gov/policy/reproducibility/index.htm

  4. National Institutes of Health. NIH Grants & Funding, Policy & Compliance. Guidance: Rigor and Reproducibility in Grant Applications [online]. https://grants.nih.gov/policy/reproducibility/guidance.htm

  5. National Institutes of Health. Office of Extramural Research. Extramural NEXUS. “Open Mike” Blog. Lauer, M., Take Advantage of Our Many Resources for Enhancing the Rigor of Animal Research [online]. February 11, 2023. https://nexus.od.nih.gov/all/2023/02/10/take-advantage-of-our-many-resources-for-enhancing-the-rigor-of-animal-research/

  6. AWR §2.31(e)(3).

  7. AWR §2.31(d)(1).

  8. AWR §2.31(e)(2).

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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 OLAW and USDA. Lab Anim 52, 191 (2023). https://doi.org/10.1038/s41684-023-01235-9

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