Policy
Each of the PIs at the sites must comply with the problem reporting requirements of the Reviewing IRB. The Reviewing IRB must communicate problem reporting requirements at the time of initial approval.
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. Affiliated institutions are not signatories of 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.
Unanticipated Problem – A problem that is unanticipated or unexpected, related to the research and places subjects or others at a greater risk of harm than was previously known or recognized. Unanticipated problems include adverse events (related, unexpected, place subjects or others at risk of harm), protocol deviations and other problems.
Procedure
1. The Reviewing IRB is responsible for communicating problem reporting requirements to the PIs at all the approved sites. This includes unanticipated problems and noncompliance reports. The Reviewing IRB must also communicate timelines for problem reporting either by listing them in the initial approval letter and the site specific approval letters (when the sites are added on after initial approval of the research) or referencing the problem reporting policy along with the approval letter.
Submission of Continuing Review Application
2. When a site becomes aware of a problem that needs to be reported to the IRB as per the Reviewing IRB’s policy, the Site PI must submit the required information to the Overall PI. The Overall PI must submit the information to the Reviewing IRB in the relevant forms. Both the Site PI and Overall PI must ensure that the problem reporting timelines are met.
Review by the Reviewing IRB
3. The Reviewing IRB is responsible for the review of the problem report and determining if the problem meets the definition of:
a. Unanticipated problem involving risks to subjects or others
b. Serious or continuing noncompliance
4. The Reviewing IRB must follow its own policy and procedure for making these determinations and an action plan. When a problem is restricted to one site, the Reviewing IRB may decide to stipulate actions from the affected site. When the problem may affect the entire study, the Reviewing IRB may decide to issue stipulations for all the approved sites. The Reviewing IRB may suspend or terminate its approval for one or more sites without affecting its approval for conduct of the research at the other sites.
Post Review Communication
5. The Reviewing IRB must communicate its findings and stipulations in writing to the Overall PI. The overall PI must send a copy of the approval letter and stamped consent form to the Site PIs. When the Reviewing IRB makes a determination of unanticipated problem involving risks to subjects or others or serious or continuing noncompliance, or issues a suspension or termination, the Reviewing IRB must also communicate this information to the Relying Organization. When Affiliated Institutions are involved, the Relying Organization is responsible for informing them in a timely manner.
6. It is the responsibility of the reviewing IRB to report unanticipated problems, serious or continuing noncompliance and suspensions and terminations of IRB approval to federal agencies. The Reviewing IRB should copy the Institutional Official at all the Relying Organizations on these letters.
Responsibility
This guidance applies to those members of the clinical 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
§ List of IOs from all Participating Organizations
