Applications for non-exempt human subjects research (including clinical trials) with multi-sites submitted for due dates on or after January 25, 2018, are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of research participants.
- The sIRB policy does apply to domestic sites of wholly or partially NIH-funded multi-site studies where each site will conduct the same protocol.
- The sIRB policy does not apply to:
- Foreign sites.
- Research training (T) awards.
- Domestic sites for which more than a single IRB review is required by law, including tribal law governing an American Indian or Alaskan Native tribe.
If applicable, provide a statement naming the sIRB of record in the Just-In-Time submission prior to award. [Note that the sIRB plan is no longer a requirement in FORMS-F.]
The Authorization Agreement, which is also called a reliance agreement, documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the sIRB.
The following examples are available:
- The Office for Human Research Protections (OHRP) has posted a template for a very simple reliance agreement (“IRB Authorization Agreement”).
- NIH’s National Center for Advancing Translational Sciences (NCATS) has developed detailed resources, including the reliance agreement that will be used by the Clinical and Translational Science Awards Program: the Streamlined, Multi-Site, Accelerated Resource for Trials (SMART) IRB Reliance Platform.
Exemption for domestic sites
Exemption to the sIRB policy can occur when federal, state, tribal, and/or local laws/regulations/policies require local (site-specific) IRB review. In these cases, applications should:
- Indicate that review by an sIRB will not be possible for all or some sites (specify which sites) because local IRB review is required by an existing federal/state/tribal/local law or policy.
- Include a specific citation to the relevant law, policy, or regulation.
- Budget should include costs associated with local IRB review at excluded sites.
- Note: Policy-based exceptions are approved without review by the NIH sIRB Exceptions Review Committee (ERC).
For other exemption requests with compelling justification for local IRB review:
- NIH will determine whether to grant an exemption. These require the review and approval of the NIH ERC. Applicants should:
- First contact the NIDCD Clinical Trials Section to discuss the potential exemption request.
- Indicate which site(s) is requesting an exception to the use of the sIRB.
- Provide compelling justification based on ethical or human subjects protection issues or other well-justified reasons.
- Note: If you intend to request an exception to the sIRB policy based on compelling justification, do not account for this exception in your proposed budget. The proposed budget must reflect any necessary sIRB costs without an exception (i.e., applicants should not assume that an exception will be granted when considering sIRB costs to include in the budget). The budget should not include costs for local IRB review at the requested exception site.
Refer to the following sIRB notices for additional guidance and details:
- NOT-OD-16-094: Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- NOT-OD-16-109: Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-Site Research
- NOT-OD-17-076: Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- NOT-OD-18-003: Guidance on Exceptions to the NIH Single IRB Policy
- NOT-OD-18-004: Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- NOT-OD-20-058: Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research