Changes to the Pharmacy & Therapeutics (P&T) Review and Approval of Human Subjects Research
Effective immediately, any IRB-01 or IRB-03 researchers conducting human subjects research requiring P&T approval needs to be aware that the Pharmacy & Therapeutics Committee and the Pharmacy & Therapeutics Investigational Drug Service (IDS) reviews have now been split. P&T and P&T IDS will be recognized as two separate committee reviews in the HawkIRB application system.
With these changes, the HawkIRB system will automatically notify two separate committee contacts when studies require P&T and P&T IDS to review and approve. A separate committee line has also been created for the P&T IDS to document questions, comments, and committee approvals.
- This notice was sent to researchers conducting research under IRB-03 because of the ability to conduct both UI and VA research.
- As a general rule of thumb, if the UIHC P&T review is required based on how the PI completes the application P&T IDS review will also be required.
- Both P&T and P&T IDS representatives have the ability to go into the other committee review section of the HawkIRB research application and document when their approval is complete.
- P&T IDS will not have an approval memo like P&T.
- The other committee review section of HawkIRB is configured to allow both adding committee comments and by a final date of approval.