Pre-approval activities:

• Determine what level of review you need

  An important thing to determine is whether your research is likely to need full or expedited review or whether it is actually exempt from review. This UM IRB webpage will help you make this determination.

• New guidance on determining system-generated exemption

  Within qualifying human subjects exemption categories, there is now an option for the Principal Investigator to obtain a system-generated exemption letter based on responses to key questions. The IRB does not review these projects.

• Determining IRB jurisdiction

  Follow this link for information to help you determine whether your project falls under the IRB-HSBS or IRB-MED for review.

• The eResearch Regulatory Management system (eRRM)–or just eResearch for short–provides review and approval processes for the U-M Institutional Review Boards (IRB) and the U-M Institutional Biosafety Committee (IBC).

• Preparing a new application.

  If you’re just getting started for the first time, this page provides guidance on submitting your application through eResearch.

  Hint: pay attention to the invocation to enter your information clearly, concisely, and consistently throughout the application sections and in the associated study documentation (e.g., protocol, informed consent, recruitment materials, interview/study instruments).

• Define roles of external collaborators

  If your project involves collaborators outside of University of Michigan, read through this information to understand more about how to address related IRB issues.

• Make a plan to ensure data security

  IRB-HSBS recommends that research teams consistently follow the core data security controls (you’ll find at this link), whether or not the research involves the collection of personally-identifiable data.

• Write good informed consent documents

  IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements, as well as other required regulatory and institutional language. The templates listed at this link include the new consent elements outlined in the 2018 Common Rule.

• Using eResearch to submit your application

  This link provides step-by-step guidance on using eResearch to submit your application.

Post approval activities:

• Submit an amendment

  Any changes to your approved IRB application require that you submit an amendment.

• Scheduled continuing review

  This is for annual review. Changes to the Common Rule, however, mean that many studies reviewed by the IRB HSBS will not need scheduled continuing review. This link provides more information about that.

• Report an adverse event

  Read more at this link to find out what events and incidents that may occur in the process of conducting your research need to be reported to the IRB.