Single IRB (sIRB)
An NIH requirement for completing grant applications (new, renewal, revision or resubmission) with receipt dates on or after January 25, 2018, requires that certain human subjects research protocols be reviewed by a single IRB (sIRB). Ongoing non-competing awards are not covered until there is an application for a competing renewal.
This requirement applies to human subjects research that is:
- wholly or partially supported by NIH grants, cooperative agreements, contracts or NIH Intramural programs;
- conducted in the United States; and
- where the same research protocol is being conducted at more than one site.
The requirement does not apply to human subjects research that is:
- funded by NIH career development, research training or fellowship awards; or
- categorized as an Exempt protocol by the IRB.
Actions Necessary to Meet NIH's sIRB Requirement
Prior to Proposal Submission
- Confirm with the CMU IRB that your work meets the requirement for sIRB.
- Consult with the CMU IRB and your collaborators to identify the “IRB of Record/sIRB” for the study.
- Develop an sIRB plan for inclusion in your Funding Proposal.
- Describe the use of a single IRB that will be selected to serve as the IRB of record for all study sites. Where possible, identify the IRB that will serve as the single IRB. For delayed-onset research, where the IRB cannot be identified, applications/proposals should include a statement indicating that award recipients will follow the NIH single IRB policy and will provide a single IRB plan to the funding NIH Institute or Center prior to initiating a multi-site protocol.
Prior to Beginning Human Subjects Research
- Finalize the plans for the sIRB.
- Confirm with the CMU IRB that a reliance agreement is in place.
- Finalize the communication plan between the parties (see template).
- Submit and obtain IRB approval from the sIRB.
After Research has Commenced
- Report any unanticipated problems or adverse events to the CMU IRB.
- Notify the CMU IRB of any modifications of the protocol, including change in study personnel.
- Follow the communication plan.
Consult the CMU IRB and/or the sIRB with questions.