Notice Number: NOT-OD-19-050

Key Dates
Release Date: January 2, 2019

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to provide guidance to the extramural research community regarding the NIH implementation of the Final Rule amending the Federal Policy for the Protection of Human Subjects (Common Rule). HHS, along with other Common Rule departments and agencies, published the Final Rule in the Federal Register on January 19, 2017 and subsequently amended the Final Rule to delay the general compliance date until January 21, 2019.

Several provisions in the Revised Common Rule may result in changes to NIH policies and procedures, including: 1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research; 2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website; 3) changes to categories of research that qualify for an exemption, and 4) removal of the requirement for annual IRB reviews for certain categories of research. Additional details, including requirements and processes for adopting the new provisions, can be found in the Final Rule.

As of January 21, 2019, studies initiated on or after that date, ongoing studies that voluntarily transitioned to the Revised Common Rule, and studies that voluntarily implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019), are expected to comply with all Revised Common Rule requirements for the remainder of the study. For these studies, the following NIH provisions will apply:

• NIH will no longer require IRB review and approval of the entire grant application or contract proposal. Instead, the IRB must review and approve the research (e.g. a research protocol) for all NIH-supported non-exempt human subjects research studies. Recipients must provide certification to NIH that the IRB has reviewed and approved the research (e.g. research protocol).

• For NIH-funded or supported clinical trials, informed consent documents must be posted on a public federal website after recruitment closes and no later than 60 days after the last study visit. More information about these requirements is available at https://grants.nih.gov/policy/clinical-trials/informedconsent.htm.

• Applications or proposals that include studies to which the Revised Common Rule applies should take note of changes to categories of research qualifying for exemption and take care to select the appropriate category. Questions and answers about changes to exemptions may be found at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#exemptions.

• For applications submitted for due dates on or after January 25, 2019, NIH will transition from E (e.g. E4) to "X codes (e.g. X4) to reflect categories of exempt research. Those submitting applications for due dates on or after January 25, 2019 will have the option of selecting exemption 7 or 8, if applicable. Applicants may see these changes in applications, summary statements, and progress reports. For contracts, the option of selecting exemption 7 or 8, if applicable, is effective on all solicitations issued on or after January 25, 2019.

• NIH will no longer require annual IRB review unless such review is required by the Revised Common Rule or other federal, state, or local regulation or policy, or otherwise specified in the Funding Opportunity Announcement or contract solicitation.

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration
Telephone: 301-435-0949
Email: [email protected]