Once again, the National Institutes of Health (NIH) has extended flexibilities for registering and reporting results of Basic Experimental Studies with Human Participants (BESH) to ClinicalTrials.gov. The May 6, 2024 notice extends leniency through September 24, 2025, and applies to research funded through designated BESH Notices of Funding Opportunity (NOFOs). The original announcement to delay enforcement was issued in July 2018. (See history of notices below)
Researchers will not be expected to transfer their research information to ClinicalTrials.gov. According to the notice, ‘these studies meet both the NIH definition of a clinical trial and also the federal definition of basic research’. This notice replaces NOT-OD-22-205, which was set to expire on September 24, 2024.
In addition to the extension, the notice indicates that 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). Without providing details, NIH indicated that it is developing an alternate approach for awarded BESH NOFO that will allow the posting of summary results information in a designated docket in Regulations.gov. The alternative approach will meet the expectations of results reporting under the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. NIH will provide relevant resources to support registration and submission of summary results information. FABBS will keep our members posted as more information becomes available in the coming months.
Over the years, FABBS has worked closely with colleagues at the National Library of Medicine to capture the methods and processes used in basic behavioral science that differ from traditional pharmacological clinical trials. Due to significant differences, FABBS has argued that BESH research should have more user-friendly options for registration and reporting. FABBS efforts helped to inform this 2020 webinar outlining the nature of the reporting challenges: NIH-Funded Basic Experimental Studies with Humans (BESH): Registration and Results Reporting Webinar.
For more information, see the NIH BESH resources webpage, Frequently Asked Questions (FAQs), Special Considerations for BESH webpage, and the NIH Grants Policy Statement (GPS).
- August 30, 2022 - RESCINDED – Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants.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.
