Qualifications for Principal Investigators of Human Subjects Research

Reprinted from UF Administrative Memo
July 11, 2013

Working with the three UF IRB’s (IRB-01, 02, 03), faculty stakeholders, and research deans in affected colleges, the Office of Research has developed guidelines to better define the qualifications needed to be a Principal Investigator (PI) of a human subjects research project.

The new guidelines are posted on the UF IRB website and specifically address the role students can play in overseeing human subject research. The University must ensure that PIs are suitably qualified and accountable for all aspects of research projects, and that other investigators are qualified to fulfill the requested role. The IRBs designate as PI the person who either conducts and/or oversees the entire protocol. The PI is also the person held accountable by the University and IRBs to ensure all human subjects’ regulations and any financial issues are addressed. A PI often delegates some of the research activities to students, study coordinators, or others; however, the PI remains accountable for the protocol.

These guidelines were updated to be consistent with peer institutions, are effective July 15, 2013, and will apply to any new protocol or revision request submitted. They are available at http://irb.ufl.edu/docs/studentpolicy.pdf.