It is true that there is no clear regulatory guidance on this matter; however, the Organisation for Economic Co-operation and Development's Principles of Good Laboratory Practice state that the PI is responsible for ensuring “that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice1.” The AWRs define the PI as “an employee of a research facility, or other person associated with a research facility, responsible for a proposal to conduct research and for the design and implementation of research involving animals2,” and go on to summarize the PI's responsibilities as (1) to “submit proposed activities and significant changes to activities to the [IACUC] for approval” and (2) to “provide acceptable written justification to the IACUC for areas of noncompliance with the [AWA]3.” These guidelines would indicate that the PI should be involved in monitoring the conduct of his/her studies at a level that goes beyond veterinary oversight.

By listing herself as the PI, Schope has taken on all regulatory responsibility for any studies being run by her 'tenants.' Schope can and will be held fully accountable for any cases of noncompliance under these studies, including of course noncompliance with the Animal Welfare Act. Without understanding exactly what Great Eastern's IACUC Chair means by “intimately involved,” it appears that Schope is reluctant to have anything more that a cursory involvement in the research being conducted by her tenants. Schope should rethink her stance, consider assigning someone more involved as PI (probably requiring some modifications to the contracts), or consider terminating the contracts entirely.

It would likely behoove Great Eastern to provide an official (internal) document that clearly defines the role of a PI.

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