Study Responsibility & IRB Paperwork
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.
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.
affiliation with UF, Shands, or NF/SG VAMC ends
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.
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.