NOT-OD-18-003: Guidance on Exceptions to the NIH Single IRB Policy

Guidance on Exceptions to the NIH Single IRB Policy

Notice Number: NOT-OD-18-003

Key Dates
Release Date: October 11, 2017

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to provide additional guidance to the extramural research applicant and offeror community regarding requests for an exception to the NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research.

Exceptions to the NIH sIRB Policy

The sIRB policy applies to domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research.

The policy does not apply to:

Foreign sites; or
Career development (K), institutional training (T), or fellowship awards (F).

Exceptions to the policy will be made where the proposed sIRB would be prohibited by a federal, state, or tribal law, regulation or policy (policy-based exceptions). Policy-based exceptions are automatically granted when identified in the sIRB plan (see Application Guide for grants; or Document Generation System for R&D contracts).

The NIH sIRB policy allows the consideration of requests for other exceptions not based on a legal, regulatory, or policy requirement, if there is a compelling justification for the exception. These other exceptions must be reviewed and approved by NIH.

Who Should Request an Exception to the NIH sIRB Policy?
Applicants/offerors should identify any policy-based exceptions in the sIRB plan.

If the applicant, offeror, or awardee believes that one or more research sites should be exempt from the use of the single IRB of record to conduct local IRB review due to compelling reasons, they must request an other exception and provide compelling justification in the sIRB plan.

Identification of NIH sIRB Policy Exceptions

If review by the sIRB will not be possible because local IRB review is required by an existing federal, state, or tribal law, regulation or policy, indicate which site(s) require local review and include a specific citation to the relevant law, regulation, or policy. Policy-based exceptions are approved without review by the NIH sIRB Exceptions Review Committee (ERC).

Steps to Request an Other Exception to the NIH sIRB Policy

Exception requests not based on a federal/state/tribal law, regulation, or policy require the review and approval of the NIH ERC. Applicants/offerors who wish to seek an other exception should contact the Program Officer (PO) or Contracting Officer (CO) to discuss potential exception requests, and then follow the steps below:

Applicants must include justification for an other exception in the sIRB plan attachment within the grant application (section 3.2 in the Study Record: PHS Human Subjects and Clinical Trials Information form, see Application Guide).
Offerors shall follow the instructions that are contained in the Request for Proposal (RFP) for submitting an exception request.
Applicants/offerors must include the name of the site(s) for which an IRB other than the sIRB of record is proposed to review the study for the site(s).
Applicants/offerors must substantiate their exception request with sufficient information that demonstrates a compelling justification for other exceptions to the sIRB policy. The rationale should include 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).
- For instance, the justification may consider ethical or human subjects protections issues, population needs, or other compelling reasons that IRB review for the site(s) cannot be provided by the single IRB of record.
Note that the proposed budget in the application/proposal must reflect all necessary sIRB costs without an approved other exception. Applicants/offerors should not assume that an other exception will be granted when considering what sIRB costs to include in the budget.

Post-Award Exception 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 (see Steps to Request an Other Exception to the NIH sIRB Policy above).

Notice of Approval or Disapproval of Other Exception Requests

For grant applications, after peer review has been completed, the exception request may be submitted to the NIH ERC at the IC’s discretion based on the justification provided. Only the NIH ERC may approve other exception requests. Applicants will be notified of the final decision by their IC’s PO prior to award. Approved exceptions will be incorporated in the terms and conditions in the Notice of Award.

For contracts, single IRB exception requests will be considered after peer review for those proposals in the competitive range. All requests for exceptions must be reviewed by the NIH ERC. Offerors will be notified of the final decision by the CO prior to award. Approved exceptions will be incorporated in the term and conditions in the contract award. Also, any exception requests submitted after award must be submitted to the CO and reviewed by the NIH ERC. The decision of the NIH ERC is final. No further revisions of the exception request will be accepted.

For both grant applications and contracts, the award budget will likely need to be adjusted if an exception is granted.

Time Limited Exception: Ancillary Studies to Ongoing Research without a Single IRB

NIH funds many awards that are ancillary to other ongoing studies, or parent studies. During this transitional time, new multi-site non-exempt human subjects ancillary studies, both grants and contracts, that would otherwise be expected to comply with the sIRB policy, but are associated with ongoing multi-site parent studies, will not be required to use a sIRB of record until the parent study is expected to comply with the sIRB policy. This is a standing exception until the associated parent study is submitted for competitive renewal after the effective date of the sIRB policy.

The need for this time limited exception for these ancillary studies should be documented in the sIRB plan by identifying the associated parent study and will not require review and approval of the NIH ERC.

Resources

Inquiries

Please direct all inquiries to:

NIH Office of Extramural Research
Email: [email protected]