Schope was rightfully perturbed that the IACUC changed policies midstream, but changes routinely occur in biomedical studies. For this reason, protocol and program reviews are required to revisit, update, and refine procedures and policies.

Was Schope correct that there is no applicable regulatory guidance? No. The AWRs define 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 animals1. Additionally, the Public Health Service (PHS) defines PI as the individual(s) designated by the applicant organization to direct the project or program. According to the PHS, the PI is responsible and accountable for the proper conduct of the project or program and must have the authority and responsibility for leading and directing the project, intellectually and logistically2.

If Schope became more involved with the studies, as a PI should, the work could continue. Alternately, Schope and an individual from the company could serve as co-PIs. In such an arrangement, Schope would be responsible and accountable for the study but could assign some of the specifics to her counterpart.

As the PI of record, Schope must become more involved in the studies. Additionally, collaborations could be explored. If neither option is acceptable, there may be a faculty member at Great Eastern that would agree to serve as PI on the projects. The studies could continue provided that the new PI was closely involved in the protocol. If there is no interest from the faculty, then the studies must be stopped and the start-up companies forced to find another way to perform their experiments. In this event, Great Eastern should, at a minimum, allow any ongoing studies on animals currently housed at the institution to be completed so as to not waste animal resources or cause future unnecessary duplication of the research.