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Response to Protocol Review Scenario: Did the IACUC jump the gun?

Lab Animal volume 46, pages 420–421 (2017)Cite this article

Before directly addressing the question posed, someone considering this situation would have to make a number of assumptions. The first assumption is that Neiman and her lab have already obtained the required DEA registration and state licenses necessary for using controlled substances in research. A second assumption is that Neiman is not using opioids from schedule 1, because if she were, according to the Controlled Substances Act of 1970 (ref. 1; §1301.18), she would have to submit some form of institutional approval in her application. Since her study is with animals, the third assumption is that the IACUC's final approval would have been the document to submit along with her DEA 225a form to attain her registration. If this were true, then the issues revealed in the situation would not have occurred.

According to the PHS Policy2 and the AWAR3, the IACUC can only approve, require modifications, or withhold approvals. In this situation the IACUC's approval occurred one week before the OHS' approval. So what was the “final approval” that was delayed? There currently is no regulation concerning provisional or conditional approvals. Furthermore according to the NIH website, if a protocol lacks substantive information necessary for the IACUC to make a judgment, then it should be considered incomplete and review deferred until the requisite information is provided by the investigator. Would the OHS approval be considered substantive enough? I propose that the IACUC should have waited until all documents were submitted before reviewing.

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References

  1. U.S Department of Justice. Code of Federal Regulations (2010). (§1301.18)

  2. U.S. Department of Health and Human Services. Public Health Service Policy on Humane Care and Use of Laboratory Animals (2015).

  3. United States Department of Agriculture. Animal Welfare Act and Animal Welfare Regulations (2013).

  4. The IACUC Handbook 3rd edn. (ed. Silverman, J., Suckow, M. & Murthy, S.) (CRC Press, Boca Raton, 2014).

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  1. Veterinary Clinical Sciences, The University of the West Indies, Champ Fleurs, Trinidad

    Jenelle Johnson

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  1. Jenelle Johnson
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Johnson, J. Response to Protocol Review Scenario: Did the IACUC jump the gun?. Lab Anim 46, 420–421 (2017). https://doi.org/10.1038/laban.1367

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