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

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.