Institutional Review Board (IRB) Submissions

Overview

Research teams should document which members of their team will be responsible for managing U-M Institutional Review Board Medical School (IRBMED) applications in eResearch or other regulatory management systems. Additional documentation should include:

  • Tracking tools for annual renewals and other document due dates

Failure to submit your annual renewal in a timely manner could result in study expiry and halt of research

  • Responsibility for reporting other information to the IRB such as ORIOS, AES, and reports

As stated in the FDA Information Sheets, if a lapse in IRB approval occurs, all research should stop and no new subjects should be enrolled. Please refer to the IRBMED website and then click on the AE/ORIO Guidance for reporting instructions regarding Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Protocol Deviations.

IRBs are required to function under written procedures; one of these procedural requirements (21 CRF 56.108 a 3) requires ensuring prompt reporting to the IRB of changes in a research activity. For example, the completion of a study is a change in activity and should be reported to the IRB.

Related Resources

Title 21 CFR 56.108 IRB functions and operations

U-M Institutional Review Board Medical School (IRBMED)

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials

Downloadable Templates and Appendices

IRB Submissions.docx

Questions?

Contact us at MICHR-SPGSupport@umich.edu.

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