- 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 on the HIC application by email.
- Once questions/revisions addressed, a PPRC Administrative Approval letter will be e-mailed back to the PI or entered into the eCOEUS system.
- 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. If the protocol is submitted via eCOEUS, the protocol will be rejected with a message that it requires committee review, and the primary reviewer will be communicated to the PI via eCOEUS and/or an e-mail.
- 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 firstname.lastname@example.org
- 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, 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 HIC will require two copies of the PPRC Review and Recommendations document, and the PPRC approval letter if submitting via paper. If submitting via eCOEUS, the forms will be uploaded into the system, after the investigator submits the protocol documents with the required revisions as noted above.
- Standard HIC review will then follow.