Key Dates

Related Announcements

• August 30, 2022 - RESCINDED - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants. See Notice NOT-OD-22-205.
• March 23, 2021 - RESCINDED - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants. See Notice NOT-OD-21-088.
• July 24, 2019 - RESCINDED - Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants. See Notice NOT-OD-19-126.
• October 26, 2018 - Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans. See Notice NOT-OD-19-024.
• July 20, 2018 - Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants. See Notice NOT-OD-18-212.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This notice replaces NOT-OD-22-205. The purpose of this notice is to further extend interim policy flexibilities, regarding registration and results reporting for a subset of NIH-funded research whose primary purpose is basic experimental studies with humans (BESH) submitted in response to designated BESH Notices of Funding Opportunity (NOFOs). These studies, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, meet both the NIH definition of a clinical trial and also the federal definition of basic research.

Extension of Some Flexibilities for BESH

NIH is extending the period of delayed enforcement for registration and results reporting, originally announced in NOT-OD-18-212, for BESH responsive to designated BESH NOFOs with application due dates through September 24, 2025. This delayed enforcement is only applicable to BESH submitted to funding opportunities designated as basic experimental studies with humans. BESH that qualified for the registration and results reporting flexibilities under this notice (NOT-OD-24-118) or any of the previous notices (NOT-OD-18-212, NOT-OD-19-126, NOT-OD-21-088, NOT-OD-22-205) will retain those flexibilities and will not be expected to transfer their clinical trial information to ClinicalTrials.gov.

Policy Implementation for BESH

BESH responsive to designated BESH NOFOs with application due dates on or after September 25, 2025 will be expected to register in ClinicalTrials.gov and report summary results information to either ClinicalTrials.gov or Regulations.gov in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149).

Development of an Alternate Approach for Summary Results Reporting

NIH is developing an alternate approach for awarded BESH responsive to a designated BESH NOFO that will allow the posting of summary results information in a designated docket in Regulations.gov. This alternate approach, expected in 2026, will require linking from ClinicalTrials.gov study records to corresponding results information posted on Regulations.gov. 

This approach will be an optional alternative to summary results reporting for those rare BESH whose design precludes tabular results reporting in ClinicalTrials.gov. While NIH encourages BESH summary results reporting in ClinicalTrials.gov, the alternative approach will meet the expectations of results reporting under the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. It will also maintain NIH’s commitment to stewardship and increasing transparency by allowing all NIH-funded clinical trials to be discoverable in ClinicalTrials.gov, while offering another option for posting summary results information in support of the unique designs of these BESH. More information will be made available regarding this upcoming change in the coming months. NIH will provide relevant resources to support registration and submission of summary results information.

During the extended period of delayed enforcement for registration and results reporting, NIH continues to expect registration and results reporting for these BESH, but with the additional flexibility to register and report results on alternative publicly available platforms. Plans for meeting the NIH reporting expectations using an alternative platform should be described at the time of application in the Dissemination Plan attachment. Funded awardees for applications submitted to designated BESH NOFOs who are not using ClinicalTrials.gov to meet the policy expectation should provide in their annual progress reports the unique identifier assigned by the alternative platform, if available, and a link to the report (e.g., page or record) in the alternative platform.

NIH continues to expect Good Clinical Practice (GCP) training in accordance with NOT-OD-16-148 for all personnel involved in the conduct, oversight, or management of these BESH. NIH also continues to expect posting of informed consent forms in accordance with NOT-OD-19-110 and as required by Section 46.116(h) of the Revised Common Rule for all BESH that obtain informed consent. Additionally, all such applications continue to require completion of the full PHS Human Subjects and Clinical Trials Information form, and will be evaluated using the clinical trial review criteria.

For more information, please visit our BESH resources webpage, Frequently Asked Questions (FAQs), Special Considerations for BESH webpage, and the NIH Grants Policy Statement (GPS).

Inquiries

Please direct all inquiries to:

NIH Grants Information
Email: [email protected]