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Clarifying Clinical Trials and IACUC Oversight

Lab Animal volume 51, page 154 (2022)Cite this article

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To the Editor — In the January 2022 issue of Protocol Review in Lab Animal, the authors provide a scenario in which a Principal Investigator (PI) created a chemotherapeutic in vitro that was effective against cancer cells. This PI then collaborated with a veterinary practitioner to evaluate the drug in a clinical trial with verbal owner consent. The intent was to obtain preliminary data for an NIH proposal and new drug application. The GEU IACUC found the PI to be in non-compliance and that this activity required IACUC oversight.

Clinical trials are commonplace, particularly with institutions that have a veterinary teaching hospital. It’s important to clarify the role and responsibilities the IACUC has in the oversight of these activities and when non-compliance exists as previously described1.

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References

  1. Kendall, L. V., Petervary, N., Bergdall, V. K., Page, R. L. & Baneux, P. J. R. J. Am. Vet. Med. Assoc. 253, 980–984 (2018).

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  2. National Institutes of Health Grants Policy, Part 1: NIH Grants General Information, 2.3.6. Legal Implication of Applications. https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3.6_legal_implications_of_applications.htm

  3. AVMA. VCPR: the veterinarian-client-patient relationship. Available at: https://www.avma.org/KB/Resources/Reference/Pages/VCPR.aspx. Accessed Oct 26, 2017

  4. Office of Laboratory Animal Welfare. Frequently asked questions: PHS policy on the humane care and use of laboratory animals. Available at: grants.nih.gov/grants/olaw/faqs.htm#527. Accessed Apr 5, 2017

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  6. AVMA. Establishment and use of veterinary clinical studies committees. https://www.avma.org/resources-tools/avma-policies/establishment-and-use-veterinary-clinical-studies-committees

  7. AVMA, AVMA Animal Health Studies Database-Learn About Veterinary Clinical Studies, https://ebusiness.avma.org/aahsd/more_info/veterinary_clinical_studies.aspx

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Authors and Affiliations

  1. Laboratory Animal Resources, Colorado State University, Fort Collins, CO, USA

    Lon V. Kendall

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  1. Lon V. Kendall
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Correspondence to Lon V. Kendall.

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Kendall, L.V. Clarifying Clinical Trials and IACUC Oversight. Lab Anim 51, 154 (2022). https://doi.org/10.1038/s41684-022-00979-0

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