In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) provides the following clarifications.
The PHS Policy does not specifically address reporting channels for post-approval monitoring (PAM) personnel. OLAW recommends in previous guidance that direct, clear and straightforward lines of responsibility and corresponding authority allow organizations to respond quickly and effectively1. The Institutional Official (IO) in the scenario should clearly define and assign responsibilities and reporting channels for monitoring animal care and use to safeguard animal welfare2. While not required by the PHS Policy, a PAM program helps ensure the wellbeing of the animals and may also provide opportunities to refine research procedures3. If the study in question was PHS or NSF-supported, the incident qualifies as reportable to OLAW because it was a “failure to adhere to an IACUC-approved protocol”4. As such, the IACUC must be informed of the incident and through the IO promptly provide OLAW with an explanation of the circumstances and the actions taken to address the noncompliance.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.4. (US Department of Health and Human Services, Washington, DC, 2006, revised 2017). https://grants.nih.gov/grants/olaw/faqs.htm#680
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. pp. 23–24 (National Academies Press, Washington, DC, 2011).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.6. (US Department of Health and Human Services, Washington, DC, 2006, revised 2017). https://grants.nih.gov/grants/olaw/faqs.htm#682
National Institutes of Health. Notice NOT-OD-05-034, Guidance on Prompt Reporting to OLAW [online]. (National Institutes of Health, Washington, DC, 24 February 2005).
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Brown, P. A Word from OLAW. Lab Anim 46, 289 (2017). https://doi.org/10.1038/laban.1316
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DOI: https://doi.org/10.1038/laban.1316
