- Investigator submits protocol and associated documents as indicated above.
- Protocol will be triaged to an administrative review or full committee review.
Administrative Review - Non-interventional, minimal risk studies may be administratively reviewed by either one of the PPRC chairs or the PPRC Coordinator.
- Any questions about the protocol or revisions requested will be communicated directly to the PI and protocol correspondent indicated in IRES IRB by email. Any requested revisions should be uploaded to IRES IRB.
- Once questions/revisions addressed, a PPRC Administrative Approval letter will be e-mailed back to the PI.
- The protocol then can proceed to the HIC.
Full Committee Review- Interventional studies that are deemed greater than minimal risk to minors will be scheduled for full committee review.
- A primary reviewer will be assigned to review the protocol. This will be communicated via e-mail to the PI.
- The reviewer will discuss and/or email potential revisions with the PI. The coordinator will perform a regulatory review and send revisions to the investigator as well (simultaneously).
- Revised documents are submitted to the PPRC at email@example.com
- Protocols having completed primary and regulatory review (with all revisions completed) will be distributed to the entire committee. This distribution occurs one week before the scheduled committee meeting, thus changes must be submitted by this time.
- The PI will be invited to the PPRC meeting to provide a brief introduction to the protocol for the members. Final discussion and approval of the protocol will occur at this meeting, and the investigator will be expected to address any questions that members may have.
- The committee (quorum of 8) will vote on the risk assessment and approval of the protocol. The Committee may approve the protocol, approve the protocol with revisions, or defer the protocol.
- If the protocol is approved with revisions, the Coordinator will send the investigator the PPRC Review and Recommendations Form which will include all necessary revisions for final approval and also include the risk assessment agreed upon by the Committee.
- When appropriate revisions to the protocol are made and uploaded to IRES IRB, the Coordinator will approve the protocol (with input, as necessary, from the primary reviewer, content experts on the Committee, the Chairs, and the Committee biostatistician). The Review and Recommendations Form will be sent back to the investigator denoting the approval, along with a PPRC approval letter.
- The study team should upload the PPRC Review via IRES IRB.
- Standard HIC review will then follow.