OHSRP Revised Guidance: NIH Single IRB Policy in the Context of the Intramural Program

This guidance is essential reading for all investigators and IRBs involved or reviewing multi-site protocols in the intramural research program (IRP).

There have been important clarifications made by the authors of the NIH Policy on the Use of a Single IRB for Multi-Site Research (NIH sIRB Policy) regarding how it applies to the IRP. OHSRP is issuing this revised guidance to help establish an accurate understanding of how the policy applies to the IRP and to ensure compliance with sIRB requirements.

What is the NIH sIRB Policy?

• The NIH sIRB Policy came into effect on January 25, 2018.
• The aim of the NIH sIRB Policy is to streamline the review of multi-site research without compromising protections. It requires that all domestic sites of NIH-funded multi-site studies use an sIRB to review nonexempt human subjects research under the applicable regulations (45 CFR 46 and 21 CFR 56).
• Multi-site studies are those that use the same protocol to conduct non-exempt human subjects research at more than one site and the Policy applies no matter the extent to which an individual site is involved in the protocol’s research activities.
  • For example, a multi-site study involves 3 sites. Site A will enroll all subjects. Site B will analyze identifiable samples. Site C will administer one procedure to a sub-set of subjects. All these sites are considered part of the same multi-site protocol.
• The sIRB Policy applies to multi-site studies that receive any funding from the NIH.
• The Policy does not apply to foreign sites, nor career development, research training or fellowship awards.
• Exceptions are available where use of an sIRB is prohibited by a federal, tribal, or state law, regulation, or policy (known as “policy-based exceptions”). These are granted automatically and do not need to go through any additional approval process.
• An exception can also be available in cases where a site provides a “compelling justification” for not being subject to the Policy. These are considered by the NIH Exceptions Review Committee. An exception on this basis is expected to be rare.

How does the NIH sIRB Policy apply to IRP Research?

In practice, how the sIRB Policy was applied to the IRP turned out to be TOO NARROW and there has since been a SIGNIFICANT change in our understanding of the sIRB Policy. Recent guidance from the Policy’s authors has refined how the Policy applies to the IRP, and when the involvement of the IRP triggers sIRB requirements for all other involved sites, regardless of their respective funding for that specific study.

For all protocols with IRB approval before January 25, 2018, the NIH sIRB Policy is NOT triggered when:

1. The NIH IRP is going to be added as a new study site to an existing multi-site study where all/ some of the existing sites have local IRB review, or

2. An NIH protocol reviewed by an NIH IRB needs to add a new study site.

• In examples 1 and 2 above, the extent to which the new study site is going to be involved in the study (i.e., enrolling subjects and carrying out all procedures vs only analyzing identifiable data for a sub-set of subjects) has no bearing on whether the sIRB Policy applies or not.

For all protocols with IRB approval before January 25, 2018, the NIH IRP does NOT automatically become SUBJECT to the NIH sIRB Policy but may choose to adopt it when:

1. The NIH IRP is involved in an existing multi-site protocol where all participating sites currently have local IRB review and the extramural sites subsequently apply for a RENEWAL of NIH funding.

• • Applying for a renewal of NIH funding triggers the sIRB Policy for all involved extramural sites. This means that existing IRB arrangements where there has been local review for individual sites must change and an sIRB has to provide oversight for all the sites if the renewed funding is awarded.
  • The triggering of the sIRB Policy for the extramural sites does not subject the IRP to the sIRB requirement because the IRP’s funding is not being renewed. The NIH IRB can therefore continue to provide oversight for the NIH’s role in this protocol.
  • The extent of the IRP’s involvement in the study has no bearing on whether the sIRB Policy applies.
  • Although the IRP has discretion to use an sIRB, there may be compelling reasons to choose to do so. OHSRP encourages IRP investigators to use the opportunity to consider converting to using an sIRB. The NIH study teams involved in this situation may contact OHSRP to discuss the merits of doing so.
  • When the NIH funding of extramural sites is renewed, the sIRB Policy is not automatically triggered for the IRP like it is for the extramural sites. The IRP has discretion to choose to adopt the sIRB Policy.

What's next?

OHSRP and the IRBO are actively working to help the HRPP community understand the scope of NIH studies that are subject to the NIH sIRB Policy. If a study is subject to the Policy, we will work with the NIH study team to determine the appropriate next steps. These may include establishing whether the NIH IRB can serve as the sIRB and executing reliance agreements to allow external sites to rely on the NIH IRB; or facilitating the reliance on an external sIRB to provide oversight for the NIH’s activities.

Investigators should contact the Reliance and sIRB Team if they believe their study qualifies for an automatic exception or a compelling justification can be made to seek an exception to the NIH sIRB Policy. Please note that what is a “compelling justification” for not being subject to the Policy has not yet been defined. The Reliance and sIRB Team will work with the study team to determine the merits of putting forward an exception request.

For additional guidance please contact the Reliance and sIRB Team by phone 301-402-3713, or email nih-reliance-sirb@nih.gov.

Where can I find out more information about the NIH sIRB Policy?

Final NIH Policy on the Use of Single Institutional Review Board for Multi Site Research

Guidance on Exceptions to the NIH Single IRB Policy

Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research