What Expenses Might I Budget For When Using an sIRB?

An single IRB-of-Record (sIRB) may charge for their services on a cooperative or multi-site, non-exempt human research project.  Estimated expenses are calculated on a case-by-case basis and, if allowed by project sponsor, listed as a direct cost in the budget for a funding proposal and award.

Common IRB services include, but are not limited to:

• IRB Reviews
  • Initial review of the research protocol, investigator/site qualifications, informed consent plan and documentation, and subject recruitment materials
  • Continuing/annual protocol review (regulatory requirement) for subsequent years of the project
  • "Periodic" review of any incident reports (e.g., Adverse Events or ORIOs), as they are filed
  • Amendments/modifications -  changes to the study that require IRB review
• Administrative Services - letters, study changes not requiring IRB review, etc.
• Site/Project Closeout - review of the final status report, resolution of outstanding issues 
• Other - services as applicable to the project, e.g., foreign language translation, etc.

Factors that impact the budget for sIRB services include the number of performance sites, level of risk to the participants of the research and/or to the institution, duration of the study, and more.  See the External sIRB fee schedule -sample for an example.

Always contact your U-M IRB to determine the best option and requirements for the sIRB prior to submitting funding proposals for cooperative non-exempt human subjects research.