Key Dates

Related Announcements

• May 6, 2024 - NOT-OD-24-118 - RESCINDED - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
• August 30, 2022 - NOT-OD-22-205 - RESCINDED - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
• March 23, 2021 - NOT-OD-21-088 - RESCINDED - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
• July 24, 2019 - NOT-OD-19-126 - RESCINDED - Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
• October 26, 2018 - NOT-OD-19-024 - Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans
• July 20, 2018 - NOT-OD-18-212 - Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This notice replaces NOT-OD-24-118, which is rescinded. The purpose of this notice is to indefinitely extend policy flexibilities regarding registration and results reporting per the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) 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 definition of basic research. This delayed enforcement is only applicable to BESH submitted to funding opportunities designated as basic experimental studies with humans.

Extension of Some Flexibilities for BESH

NIH is indefinitely 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, including those with application due dates on or after September 25, 2025. During the period of delayed enforcement, NIH continues to expect registration and results reporting for these BESH but with the continued flexibility to register and report results on alternative publicly available platforms, although use of ClinicalTrials.gov is encouraged.

Plans for meeting the NIH registration and results 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 all 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 or Simplified Review Criteria.

For more information, please visit the BESH resources webpage, and the Special Considerations for BESH webpage.

Inquiries

Please direct all inquiries to:
NIH Grants Information
Email: [email protected]