Single IRB Request – Grant Preparation
Research investigators must contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date to discuss options for IRBMED review of a multi-site study where University of Michigan will either be the lead or participating site. If it is determined that IRBMED will serve as the sIRB for all sites, IRBMED will provide the Investigator/Study Team with the sIRB plan to include with the grant proposal.
IRBMED has instituted a recharge fee for federally sponsored research when it serves as the single IRB of Record (sIRB). The fee is based on the number of external sites and the complexity of the study. You will receive budget information with your letter of support. Refer to the IRBMED sIRB webpage listed below for more information.
Completion of a single IRB request form is required. During the review of the information provided, the IRBMED will determine if it is appropriate for IRBMED to serve as the sIRB for the proposed project. Contact firstname.lastname@example.org with any questions.
If it is determined that IRBMED will not serve as the sIRB, the research investigators should consider whether another participating site will serve as sIRB or whether an independent IRB should be considered. IRBMED will then provide a letter of support to rely on the external IRB for inclusion with the grant proposal.
When will IRBMED act as the single IRB?
During the review of a sIRB request, IRBMED will evaluate whether it is suited to serve as the sIRB for the proposed multi-site project on a case-by-case basis.
Evaluation criteria include:
- The risk level/complexity of study design for the proposed research
- The number of participating sites
- The location of the participating sites
- What entity holds any associated IND/IDE
- Adequacy of technology platforms to support submission of information across participating sites
IRBMED reserves the right to decline being the sIRB and will support research investigators to locate an external IRB to serve in that capacity.