HRPP Manual Section 4-10

Designation as Key Project Personnel on Non-Exempt IRB Projects

Key project personnel must be listed on the Michigan State University (MSU) Institutional Review Board (IRB) application for expedited and full board projects and any changes to key project personnel must to be submitted as revisions.

“Key Project Personnel” means the Principal (Responsible) Investigator and any other persons, regardless of title or position, who are responsible for the design, conduct, or results reporting of the human subject research project and/or whose expertise is required to conduct the project, whether or not they request salaries or compensation, i.e., their absence from the project would have a significant impact on the approved scope of the project. If the research is being conducted to fulfil an education requirement (e.g. dissertation), the graduate student is considered key project personnel. Individuals who obtain private identifiable data may not necessarily need to be considered key project personnel; the determination of whether they are key project personnel would depend upon their level of responsibility and expertise. 

In addition, the following criteria are followed for projects to which FDA regulations and policies apply:

Individuals (e.g., research coordinators, research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s) and who, as part of an investigative team, will assist the investigator and make a direct and significant contribution to the data are considered to be key project personnel. The decision to consider an individual key project personnel depends on his/her level of responsibility (i.e., whether he/she is performing significant clinical investigation-related duties). In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person is key project personnel. For example, if the protocol notes that each subject needs to visit a specified internist who will perform a full physical to qualify subjects for the clinical investigation, that internist is considered to be key project personnel. Hospital staff, including nurses, residents, or fellows and office staff who provide ancillary or intermittent care but who do not make a direct and significant contribution to the clinical data, are not considered to be key project personnel. (based on FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions – Statement of Investigator (Form FDA 1572), May 2010)

While the Principal Investigator is responsible for assuring that key project personnel are listed on the IRB application, the IRB may also make the determination that an individual engaged in human subject research is key project personnel.

Although only key project personnel need to be listed on a non-exempt application, all other individuals engaged in human subject research activities must receive and maintain current human subject training, must disclose conflict of interest in accordance with the MSU Human Research Protection Program (HRPP) Manual Section 10-1, Conflict of Interest, and are subject to MSU HRPP requirements, see HRPP Manual Section 4-1, Applicability. It is the responsibility of the Principal Investigator to maintain oversight over all project personnel and to assure and to maintain appropriate tracking that these requirements are met (e.g. documentation of training completion, conflict of interest).

When non-MSU personnel are engaged in human research, there are additional requirements; see the section below.

Non-MSU Personnel Engaged in Human Subject Research 
Non-MSU personnel who are key project personnel engaged in human subject research must be listed on the MSU IRB application and any changes to key project personnel must to be submitted as revisions. When the research involves multiple institutions engaged in the human research, at least one individual from each engaged institution should be designated as key project personnel; see HRPP Manual 6-9-F, Multiple Research Sites for additional requirements.

If an individual is not otherwise an employee or agent of MSU, is not acting as an employee of any institution with respect to their involvement in the research, and is not key project personnel, the Principal Investigator must notify the MSU HRPP of their involvement in the research so an Individual Investigator Agreement can be completed. 

If an individual is not otherwise an employee or agent of MSU and is not key project personnel, but is acting as an employee of an institution with respect to their engagement in the human research, that institution will become engaged in the research. If the MSU IRB has already approved that institution as a site in the research and IRB approval is in place (either through reliance upon MSU as IRB of record or through that institution’s IRB), a revision to the MSU IRB is not required to add that individual to the project. However, if the MSU IRB has not approved that institution as a site in the research, a revision must be submitted for review and approval before human research activities can begin at that institution. The Principal Investigator should also be aware of and comply with that institution’s requirements for personnel changes.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research & Graduate Studies on 12-11-2015. Revision 1 approved by VP Research & Graduate Studies on 8-3-2017.

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