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Reply To: Clarifying Clinical Trials and IACUC Oversight

Lab Animal volume 51, page 155 (2022)Cite this article

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Kendall reply — In Summary, Dr. Guaio, a researcher from Great Eastern University (GEU), used an in-vitro process to develop a designer drug to treat cancer. Guaio developed a partnership with a private practice veterinarian, Dr. Ty, to evaluate the experimental drug in client-owned dogs. The animal activities associated with the clinical trial were not overseen by an IACUC and the objective of the clinical trial was to gather data that would be used to obtain NIH funding to further evaluate the drug.

As mentioned by the USDA respondent, the dogs involved in the study would not be considered a covered species since they are client-owned animals, and, consequently, the described activities would not be subject to the Animal Welfare Regulations (AWAR). However, GEU resources were utilized to develop the designer drug and, therefore, the activities are beholden to GEU’s policies governing animal care and use activities, which may or may not include adherence to GEU’s PHS Assurance.

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References

  1. AVMA, AVMA Animal Health Studies Database; Glossary of Terms. https://ebusiness.avma.org/aahsd/more_info/glossary.aspx#A

  2. AVMA, Policy: Safety Testing. https://www.avma.org/resources-tools/avma-policies/safety-testing

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

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Authors and Affiliations

  1. Animal Care & Use Office, University of Michigan, Ann Arbor, Michigan, USA

    Lauren Danridge & Bill Greer

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  1. Lauren Danridge
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  2. Bill Greer
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Correspondence to Lauren Danridge or Bill Greer.

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Danridge, L., Greer, B. Reply To: Clarifying Clinical Trials and IACUC Oversight. Lab Anim 51, 155 (2022). https://doi.org/10.1038/s41684-022-00980-7

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