In the scenario presented, the GEU IACUC holds that responsibility for fidelity between procedures performed and those approved ultimately lies with the Principal Investigator (PI). In contrast, Dr. Felelős, whose surname translates from Hungarian to “responsible,” does not dispute that noncompliance with the approved protocol occurred, but, rather, appears to question the existence of any regulatory basis for this assertion. In this regard, we will assume that PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the USDA Animal Welfare Act Regulations (AWRs) are relevant to Dr. Felelős’ research at GEU. While neither the PHS Policy nor the Guide note a responsibility of the PI for ensuring compliance of activities with approved protocols, the AWRs define a PI as someone who is “…responsible for a proposal to conduct research and for the design and implementation of research involving animals” (§ 1.1) and state that the IACUC may suspend an activity that is not being conducted in accordance with the description of that activity provided by the PI and approved by the Committee (§ 2.31)1. Of note, if the work under question was funded by PHS, the IACUC should direct Felelős to the NIH Grants Policy Statement which specifically states an expectation that “…the PI agrees to accept responsibility for the scientific conduct of the project…” (2.3.7.6)2. Many institutions define a responsibility for PIs to ensure compliance for work conducted under their direct and indirect supervision either in a policy or as a condition of protocol approval by the IACUC.
The particular noncompliance associated with this scenario seemingly resulted in detriment to animal welfare, as humane endpoints were exceeded. Though protocol noncompliance is not specifically defined in any of the applicable regulatory or guidance documents, the expectation that animal use activities be approved by the IACUC suggests that any excursion beyond what has been approved is generally not permissible3. Related to this, The Guide specifies the importance of “observation of laboratory practices and procedures and comparison with approved protocols” as an essential PAM component, a sentiment echoed by AAALAC and which strongly suggests an expectation for compliance with protocols4,5.
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