Key Dates

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Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Notice is to inform the research community of the NIH requirement to adhere to the Revised Common Rule to use a single IRB for NIH-supported multi-site studies conducting research at more than one domestic site. NIH has prepared this interim guidance on issues that are impacted by 45 CFR 46.114. More information about the Revised Common Rule Cooperative Research Provision may be found at https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html.

Applicability

Effective January 20, 2020, NIH-funded multi-site studies being conducted at more than one domestic site and supported by career development (K) and fellowship (F) awards that obtain initial institutional review board (IRB) approval on or after January 20, 2020 will be subject to the requirements of 45 CFR 46.114.

Guidance on OHRP’s Determination of Exception to the Required Use of a Single IRB

On November 22, 2019, as permitted by 45 CFR 46.114(b)(2)(ii), the Office for Human Research Protections (OHRP) announced in the Federal Register its determination of exception for two categories of research from the required use of a single IRB to review cooperative research under the Revised Common Rule. Relevant OHRP exception categories for NIH-supported cooperative research include the following circumstances:

a. the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or

b. NIH excepted the research from its single IRB policy before January 20, 2020.

OHRP clarified that the exception from the Revised Common Rule requirement for category b applies for the duration of NIH’s exception from the NIH Single IRB Policy for the specific research study.

As a result of OHRP’s determination, the following NIH-funded multi-site studies being conducted at more than one domestic site may continue to use multiple IRBs for the duration of the exception granted by NIH to the NIH sIRB policy, and no later than the next competing award (i.e. new and/or revision).

• Studies for which NIH approved an exception from its single IRB policy before January 20, 2020

• Studies conducted under ongoing, non-competing awards with receipt dates prior to January 25, 2018 if an IRB initially approved the research prior to January 20, 2020

Note: The exceptions identified below DO NOT apply to protocols that receive initial IRB approval on or after January 20, 2020

As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy such as domestic, multisite career development (K) and fellowship (F) awards.

Application Instructions Guidance

The modification to applicability for career development (K) and fellowship (F) awards has resulted in changes to the FORMS-E application instructions for the PHS Human Subjects and Clinical Trials Information form, which are detailed below.

Revised Language for Career Development and Fellowship Applicants and Recipients

3.2 Is this a multi-site study that will use the same protocol to conduct non- exempt human subjects research at more than one domestic site?

Career Development and Fellowship Applications with studies approved after January 19, 2020 must Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site. Do not select N/A.

Applicants who check Yes are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required by HHS regulations for the Protections of Human Subjects Research unless review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.

Resources

• 2018 Revised Common Rule

• OHRP Determination of Exception for Certain HHS-Conducted or-Supported Cooperative Research Activities Subject to the 2018 Requirements

Inquiries

Please direct all compliance inquiries to:

Office of Policy for Extramural Research Administration
Telephone: 301-435-0938
Email: grantscompliance@mail.nih.gov

Please direct all application forms and instructions to:

Office of Policy for Extramural Research Administration
Systems Policy Branch
Email: OPERAsystemspolicy@nih.gov