In response to this scenario, the Office of Laboratory Animal Welfare offers the following guidance:
In the scenario, a doctoral student and his advisor completed and published a study without IACUC approval of the animal activities. The problem was identified by the IACUC Chair after the student graduated and embarked upon a research career in his home country. The author poses the question, “How should the PI and IACUC handle this situation?”
All of the respondents correctly identified the serious noncompliance of conducting animal activities without IACUC approval. As identified by two of the respondents, the IACUC must investigate the incident, the investigation must be documented, and, if PHS funded, the noncompliance must be reported promptly to OLAW. A plan, schedule, and timeframe for correction, and prevention of recurrence of the noncompliance must be developed, reported to OLAW, and implemented, as described on the OLAW website, Reporting Noncompliance1. The PI should cooperate with the IACUC to develop and implement procedures to prevent recurrence.
In addition to the complete and well described procedures suggested by two of the respondents for investigation and correction of the noncompliance, the institution is required to 1) contact the NIH funding component to negotiate the potential refund of grant money used on an animal study without IACUC approval, and 2) notify the Program Officer about the publication of unapproved activities, as described in Guide Notices NOT-OD-07-0442 and NOT-OD-10-0813.
Additionally, The PHS Policy section V.B.4 and the NIH Grants Policy Statement chapter 4.1.1.25 require the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications related to the care and use of animals. Institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with that provided in the grant application. Accordingly, the institution must assume responsibility for this serious noncompliance and negotiate a return of funds with NIH.
The journal in which the experiment was published must be notified that the animal activities were incorrectly identified as having been conducted with IACUC approval. The journal, not the IACUC or the authors, is responsible for determining their response.
The IACUC may not retroactively review and approve the animal activities. Such an action would not mitigate the noncompliance that has been committed and would extend the impact of the noncompliance.
References
National Institutes of Health. Office of Laboratory Animal Welfare. Reporting Noncompliance, https://grants.nih.gov/grants/olaw/reporting_noncompliance.htm
National Institutes of Health. NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld. Notice NOT-OD-07-044 [online]. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html (National Institutes of Health, Bethesda, MD, 26 January 2007).
National Institutes of Health. Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals. Notice NOT-OD-10-081 [online]. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-081.html (National Institutes of Health, Bethesda, MD, 15 April 2010).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Bethesda, MD, 1986, revised 2015). https://grants.nih.gov/grants/olaw/references/phspol.htm#ImplementationbyPHS
National Institutes of Health. NIH Grant Policy Statement, chapter 4.1.1.2, https://grants.nih.gov/policy/nihgps/index.htm
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Brown, P. A Word from OLAW. Lab Anim 47, 54 (2018). https://doi.org/10.1038/s41684-018-0008-9
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DOI: https://doi.org/10.1038/s41684-018-0008-9
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