Reporting for Projects Involving a Reliance Mechanism

For projects involving a reliance mechanism, responsibilities for reporting are case-by-case and are dictated through either the IRB reliance agreement or additional study specific research plans executed for the project.  For definitions related to reliance, refer to Chapter 24 Reliance Mechanisms.

The reporting responsibilities of the Principal Investigator and the responsibilities of the IRB are the same as outlined in this policy for projects involving a reliance mechanism.

1. Pitt IRB serves as the IRB of Record for a Multi-Site and/or Collaborative Study

If the Pitt IRB is serving as IRB of Record for a multi-site and/or collaborative study, an RNI must be submitted to the Pitt IRB for any event that meets reporting guidelines that occurs at any relying site, including the Pitt/UPMC site. 

2. Pitt IRB Cedes Oversight to External Institute for a Multi-Site and/or Collaborative Study

If the external IRB of Record makes any of the following determinations for the Pitt/UPMC site, an RNI must be submitted to the Pitt IRB, including the determination correspondence from the external IRB of Record:

• Serious Non-compliance and/or Continuing Non-compliance
• Unanticipated Problem Involving Risk to Human Subjects or Others
• Suspension/termination at the Pitt/UPMC site

References

• 45 CFR 46.103(b)(5)
• 21 CFR 56.108(b) (1), 312.53 (c) (vii) and 312.66 – Investigators are required to report promptly to the IRB all unanticipated problems involving risks to human subjects or others
• OHRP - Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• Appendix M – NIH Guidelines for Research Involving Recombinant DNA Molecules
• Standard Operating Procedures for the Education and Compliance Support for Human Subject Research

5/14/2021