Institutional Review Board (IRB) Submissions Standard Practice Guideline

A guide for diligent management of IRB applications and reporting obligations through meticulous documentation and tracking of responsibilities

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Who?

This resource may be used by anyone at U-M.

When?

Available for download.

How much?

Free

What is this resource?

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.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

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