The principal investigator (PI) will submit the original IRB Protocol Submission Form and related documents/forms with all required signatures, including:
- PI and co-investigator (if applicable);
- faculty advisor (if student)
The Form and related documents/forms should be sent to:
The Office of Regulatory Research Compliance
Attn: Institutional Review Board
ORRC Administrative Review
ORRC staff will triage the protocol to ensure that the protocol submission is complete; i.e., that all required elements (e.g., training certificates, grant application, etc.) have been submitted. The protocol will then be referred to a research compliance administrator (RCA) for administrative review. The RCA will notify the PI when the protocol is accepted for IRB review.
The purpose of the administrative review is to identify issues that are either incomplete or unclear, thereby preventing or delaying approval by the IRB. Once issues are identified, the PI must respond to and/or revise the protocol before it can be referred on for IRB review. Protocols that require extensive revision or are missing a significant amount of information will take longer to review.
Although the administrative review process will materially improve the probability that the protocol will be approved, it does not guarantee approval. It is to the PI's advantage to follow this submission format to avoid delaying the review process.
A protocol wil be considered complete and accepted for review if it meets ALL the following criteria:
- the protocol form and all related documents/forms, signed by the appropriate parties, are received by ORRC. E-mail submissions will not be accepted. The protocol will be returned to the PI if it is incomplete;
- an administrative review by an RCA has determined that the PI has submitted all information necessary for the IRB to adequately review the protocol;
- a grant review has determined that the information presented in the proposed protocol is congruent with the research proposed in the grant application;
- training requirements for the PI and all research personnel have been met.
Exempt and Expedited Reviews
Applications are accepted and reviewed as they are received.
Submissions Requiring Full Board Review
Protocols accepted for review which require full committee review are placed on the agenda of the next scheduled meeting.
The PI will receive an email from the RCA indicating the date of the meeting at which their protocol will be reviewed. PIs are invited to the meeting to address any IRB questions or concerns.