Study Responsibility & IRB Paperwork

The Principal Investigator (PI) is the fully responsible for the conduct of all aspects of his/her IRB approved protocol. Due to the significance of this responsibility, IRB-01 will only accept protocol paperwork that has been signed by the PI. This assures us that the PI is aware of the conduct of his/her protocol. Paperwork signed by a Co-Principal Investigator (Co-PI) or sub-Investigator (sub-I) will not be accepted, processed, or reviewed and will be returned to the sender/PI.

Obviously PIs can sometimes be unavailable for a significant length of time (e.g. travel, medical reasons, etc.) and might not be available to oversee their protocol and/or sign protocol related paperwork. In these events, the PI must obtain a "temporary PI" to oversee the conduct of the protocol in the PI's absence and to sign any protocol related paperwork. This temporary transfer must be written, protocol specific, for specific and limited time frame, and signed by both the PI and the temporary PI. The temporary PI must already be listed as a co- or sub- investigator on the protocol (otherwise a protocol revision will be necessary). The transfer should be obtained prior to the PI's absence, and should be submitted to the IRB (1) when first obtained and (2) with any subsequent submissions that the temporary PI signs. You should use our Temporary Transfer of Study Responsibility Form.

PI's affiliation with UF, Shands, or NF/SG VAMC ends

Prior to leaving UF/Shands/VA, the PI must either (1) revise their protocol to name a new PI or (2) close their study by submitting a Study Closure Report.

In the event the PI fails to do either, responsibility for the study defaults to the PI's supervisor (department chair, dean, etc.). The supervisor is responsible for the conduct of the study and must either name a new PI and renew or close the study once approval expires.