Notice Number: NOT-OD-19-055

Key Dates
Release Date: January 11, 2019

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to provide guidance to the extramural research community about the implementation of revisions to the Final Rule on the Federal policy for the Protection of Human Subjects (Common Rule). The HHS Office of Human Research Protections (OHRP) published the Final Rule in the Federal Register on January 19, 2017 and amended the Final Rule to delay implementation until January 21, 2019.

This Notice specifically focuses on the removal of the requirement for Institutional Review Boards (IRB) review grant applications and contract proposals related to research. The revised Common Rule states the following at 45 CFR 46.103(d):

Certification is required when the research is supported by a Federal department or agency and not otherwise waived under .101(i) or exempted under .104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.

POLICY REQUIREMENT:

Effective January 21, 2019, NIH will no longer require IRB review of the entire grant application or contract proposal. However, grantees and offerors will be required to certify to NIH that an IRB has reviewed and approved all NIH-supported non-exempt human subjects research (i.e., protocols) and further provide NIH with the date of final IRB approval. The only change to NIH policy is that IRB review is no longer required for NIH grant applications and contract proposals. The certification and IRB date requirements align with current policy and Just-in-Time procedures.

NIHs IMPLEMENTATION OF THE POLICY REQUIREMENT:

Recipients must provide NIH with a certification that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB. The date of final IRB approval is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval). When human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application or proposal (referred to as "delayed onset human subjects research"), prior to the involvement of human subjects in non-exempt research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as required in the Human Subjects and Clinical Trials Information Form of the application, as well as the certification and date of final IRB approval.

Under no circumstances may NIH-supported non-exempt human subjects research be initiated prior to meeting the requirements for conducting an IRB review of protocols as well as obtaining the date of final IRB approval. NIH will not allow any funds to be used by recipients where a certification and an IRB approval date has not been provided to the funding IC.

Recipients are also reminded that any changes to study protocols that have been subject to peer review, as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute or Center consistent with Section 8.1.2.5 of the NIHGPS. Such requirements are also generally described in the Funding Opportunity Announcement and/or the Notice of Award.

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration
Telephone: 301-435-0949
Email: grantspolicy@mail.nih.gov