When the participating site submits a grant proposal as a subcontractor to the awardee/primary grant holder, the HSO office is notified via an automatic email. After review, HSO can provide a letter of support agreeing to rely on the Reviewing IRB or suggest that the lead site request an exception to the policy for IU's participation.
sIRB review is not appropriate for all research. As such, the NIH policy allows grant applicants to request an exception to the policy under one of the following allowable exception categories. The lead applicant is responsible for making exception requests. HSO will review the proposal to determine whether an exception should be requested and work with the lead applicant to submit the required information.
- Regulatory or policy exception: Local IRB review is required by an existing federal, state, or local/institutional regulation or policy. Applicant must indicate which site(s) require local review and include a specific citation to the relevant law, regulation, or policy.
- Compelling justification: Applicant should provide the rationale for why the single IRB of record cannot serve as the reviewing IRB for the site(s), and why the local IRB is uniquely qualified to be the reviewing IRB for the specific site(s).
- Post-award exceptions requests: For any post-award changes that necessitate an exception request, such as the addition of a new domestic site that may be unable to use the sIRB, awardees must contact their PO or CO. For policy-based exceptions, the awardee will need to provide the appropriate citation to verify the requirement for local IRB review for the newly added site(s) to the PO or CO. For other exceptions, the awardee must provide compelling justification to the PO or CO to be reviewed by the NIH ERC.