If requesting IRBMED to be the reviewing sIRB, contact IRBMED via MiCORES as soon as possible but at least 8 weeks prior to the grant application due date to seek authorization to commit IRBMED to this effort.
Completion of a request form in MiCORES using the Single IRB Review Core (“sIRB Core”) is required. The sIRB Core provides a single location where researchers can request that IRBMED be the sIRB of record for proposed multi-site human research. Initiate a request using the “U-M to be the Single IRB-of-Record” form. 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. Evaluation criteria include:
- Study design
- What entity/individual holds any associated IND/IDE
The number and location of participating sites
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. As applicable IRBMED will then provide a letter of support to rely on the external IRB for inclusion with the grant proposal. Commercial IRB options will also be discussed.
If agreeing to be sIRB under a federal award, IRBMED will prepare a budget estimate for any applicable direct costs associated with its review of the multi-site components of the research. Estimates are based on the number of sites and expected complexity of study oversight.
Contact email@example.com with any questions
NIH Grant Proposals
For NIH applicants, the single IRB plan is no longer required at the time of submission but a budget must be provided. However, the grant applicant must provide a statement naming the sIRB of record in the Just-in-Time submission prior to award. Provide IRBMED the information as indicated above.
AHRQ Grant Proposals
For AHRQ applicants, if this is a research project that involves more than one institution and that will be conducted in the United States, a single IRB plan must be prepared unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. The single IRB plan will be developed by IRBMED. Provide IRBMED the information as indicated above.
Other Federal Agency Requirements
Check the specific requirements associated with the grant application. Provide IRBMED the information as indicated above.
Non-federal Grant/Contract Proposals for IRBMED as sIRB
IRBMED will evaluate whether it will serve as sIRB on a study-specific basis. Provide IRBMED the information as indicated above.
Further information for institutions participating in the SMART IRB agreement:
RES_IRBMED_SMART IRB GUIDANCE COMPANION PIECE.DOCX
Further information for institutions not participating in the SMART IRB agreement:
RES_IRBMED_NON-SMART IRB GUIDANCE COMPANION PIECE.DOCX