In response to the issues posed in this scenario, the US Department of Agriculture - Animal Plant Health Inspection Service (USDA-APHIS) and the National Institutes of Health - Office of Laboratory Animal Welfare (NIH-OLAW) provide the following clarifications:

In this scenario, the Institutional Animal Care and Use Committee (IACUC) is reconsidering its standard operating procedure for who can be a Principal Investigator (PI) on an IACUC protocol. Great Eastern’s SOP allows a postdoctoral scholar (postdoc) to function as PI if the faculty mentor is listed on the protocol as the sponsor.

The Animal Welfare Act Regulations (AWAR) requires all persons involved in animal use to be qualified to perform their duties and designates the research facility as being responsible for providing training and instruction1. The PI is defined 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 animals.2” The regulations also outline the responsibilities of the PI which include but are not limited to: consulting the Attending Veterinarian on painful/distressful procedures, considering alternatives to painful/distressful procedures, and providing the appropriate medications for procedures causing more than momentary or slight pain/distress unless withholding is scientifically justified in writing2,3. As a result, it is the responsibility of the IACUC to determine whether persons designated as the PI using an AWA regulated species meet the definition and fulfill the qualifications and responsibilities as set forth by the regulations.

The Public Health Service Policy does not contain specific guidance on who can serve as PI for research involving animals. The Policy at IV.C.1.f states that “the IACUC shall determine that personnel conducting procedures on the species being studied will be appropriately qualified and trained in those procedures.4” The Policy also states that “no PHS support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with the Policy, unless the individual makes other arrangements with the PHS.4” The flexibility provided by the Policy allows the institution to define the PI within the constraints that it finds acceptable. This differs from the NIH definition of the PI on a grant application: “the individual judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant5,6”. In some cases, postdocs may be the PI on an NIH award, especially with its current interest in supporting early stage investigators7. Such postdocs qualify in their own right to serve as PIs using Great Eastern’s definition and should list themselves as their own faculty mentor. It is also of note that OLAW allows the individual listed as the PI on the grant to be different from the PI on the IACUC protocol8.