35. Requirements for Principal Investigators for Human Subject Research Projects
Requirements for individuals to serve as the Principal Investigator (PI) for human subject research differ from those required for an individual to be the PI on a sponsored project under the auspices of the University of Nevada, Reno (the University).
- This policy is concerned with requirements to be the PI for human subject research projects.
- Contact the Office of Sponsored Projects for information about the University's requirements to be the PI on sponsored projects.
Requirements for University Employees to Be the PI for Human Subject Research
University employees must meet one of the following criteria to serve as the PI for human subject research projects that are exempt under DHHS regulations or the University's IRB Flexibility Policy, or non-exempt (thus requiring IRB review, approval, and oversight).
- Faculty at the University with renewable appointments as defined in the University Administrative Manual (see UAM section 2,511).
- Visiting faculty or scientists during the time they are on the University payroll.
- Full-time classified staff at the University, with signature approval from the appropriate dean and the Vice President for Research and Innovation (contact the Office of Sponsored Projects to request approval).
- University of Nevada, Reno Emeritus faculty in residence who wish to continue their research programs, with signature approval from the appropriate dean and the Vice President for Research and Innovation (contact the Office of Sponsored Projects to request approval).
NOTE: Individuals with Letters of Letters of Appointment (LOA) at the University require special consideration because of the time limits associated with their employment. The RIO will evaluate individuals with Letters of Appointment (LOA) at the University on a case-by-case basis to determine if they may be the PI for human subject research. If the RIO determines they may be the PI, individuals with LOA must provide documentation of approval, support, and specification of responsibilities from the Chair of the program that established the LOA. The documentation must also
- indicate if the LOA is expected to be continued in subsequent semesters or is short-term, and
- specify who will be responsible for the protection of human subjects and the research records and data when the LOA contract is not in effect (e.g., between semesters, over the summer).
Requirements for Individuals from Affiliate Sites to be PI for Human Subject Research
"Affiliate Sites" refers to institutions that have an inclusive, signed agreement (generally a Memorandum of Understanding) that allows the University IRB to be the IRB of Record for human subject research conducted at or on behalf of the Affiliate Site. To serve as a principal investigator for human subjects research submitted for exempt determination by the University Research Integrity Office or for review, approval, and oversight by the University IRB, individuals at Affiliate Sites must meet one of the following criteria:
- She/he is faculty at the Site;
- She/he is clinical staff at the Site; or
- She/he is otherwise considered a qualified representative or agent of the Site, as determined/confirmed by the Affiliate Site.
Requirements for Individuals from Other External Sites to be PI for Human Subject Research
Individuals from other external sites who wish to be the PI for exempt or non-exempt human subject research to be conducted under the auspices of the University RIO or IRB must contact the RIO Director to establish a written agreement for the University IRB to be the IRB of Record for the research. The individual must also provide the RIO with a copy of her/his CV or other documentation of her/his educational, professional, and research experience.
Individuals Who May Not Serve as PI for Human Subjects Research Projects
The following categories of individuals are not eligible to serve as PI for human subject research that is overseen by the University RIO (for exempt research) or IRB (for non-exempt research):
- Adjunct faculty who are not emeritus faculty;
- Emeritus faculty who are not determined to be "in residence;"
- Temporary faculty; and
- Students and individuals in training (e.g., post-docs, residents).
NOTE: The Vice President for Research and Innovation retains the right to reject, suspend or remove the any PI or co-investigator.