Committee For the Protection of Human Subjects

Reciprocity Continuing Review

Policy

The overall PI is in charge of coordinating the submission of renewal application to the Reviewing IRB. The site PI must submit necessary information in a timely fashion to the overall PI.

Key Terms

Affiliated Institution - An institution relying on any of the Participating Institution’s IRB and formally agreeing to participate in the UT System reciprocity agreement. These institutions are not signatories on the UT System IRB Reciprocity Agreement.

Participating Organization - All UT component participating in the UT System reciprocity agreement.

Relying Organization - A participating organization that agrees to rely on another participating organization’s IRB for a specific study.

Reviewing IRB - A participating organization that agrees to serve as the IRB of record for a specific study for one or more of the other participating organizations.

Overall PI - The principal investigator at the Reviewing IRB’s organization.

Site PI - The principal investigator at the Relying Organization.

Procedure

1. The overall PI is in charge of submitting a renewal application to the Reviewing IRB in a timely manner. Continuing review will occur at the same time for all the sites even if the sites were added after the original site had received approval earlier.

2. In most institutions, the IRB sends reminders to the overall PI to turn in a continuing review application form well before the IRB approval expiry date. However, it remains the responsibility of the Overall PI and the Site PIs to ensure that continuing review approval is obtained before study expiry.

Submission of Continuing Review Application

3. The overall PI must send the Reviewing IRB’s continuing review form to all the site PIs. The overall PI must consolidate information from all the sites into a single continuing review application. The overall PI must submit the consolidated continuing review application to the Reviewing IRB. The overall PI must indicate the names of the sites whose information is included in the application. The overall PI may attach the individual forms from the Site PIs to the continuing review application.

Review by the Reviewing IRB

4. The Reviewing IRB is responsible for the review of the continuing application for all the sites. In addition to the criteria for approval and other issues considered at continuing review, the Reviewing IRB should also determine whether all the sites have provided information about the conduct of research at their site.

Post Review Communication

5. If the continuing review application is approved, the Reviewing IRB should send the approval letter and stamped consent document to the Overall PI. (Some institutions may not issue newly stamped consent forms at the time of continuing review). The approval letter should include the list of all the sites for which continuing approval has been granted. If the Relying Organization requested for direct communication, the Reviewing IRB must send a copy of the approval letter to the Relying Organization. The overall PI must send a copy of the approval letter and stamped consent form to the Site PIs.

Special Consideration – Study Expiry

6. If the continuing approval is not granted by the Reviewing IRB before study expiry, research activity must stop at all the sites. If the investigators believe that stopping the study might be harmful for participants, investigators must submit a justification to the Reviewing IRB to continue research activities. The Reviewing IRB will review such a request according to their policies and procedures.

7. If one or more sites participating in the research study did not submit information to the Overall PI for the continuing review application, the Reviewing IRB should conduct continuing review for the sites that did submit their information. For the sites that did not submit information, the study will expire. The Reviewing IRB should issue a letter asking the sites where approval has expired to stop all research activities. 

8. The Reviewing IRB must communicate information to the Relying Organization when a study has expired at the Relying Organization. If any Affiliated Institutions are involved, the Relying Organization must communicate this information to them.

Responsibility

This guidance applies to those members of the research team involved in conducting the research. This includes the following:

§ Overall Principal Investigator

§ Local Principal Investigator

§ Reviewing IRB and IRB Office

§ HRPP Staff at Relying Organization

§ Staff at Affiliated Institution

Attachments

§ Template – Continuing Review Approval Letter