March 23, 2021
NOT-OD-22-205 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
NOT-OD-19-126 - Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
NOT-OD-18-212 - Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
NOT-OD-19-024 - Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans
NOT-OD-22-008 - Guidance electronic Research Administration (eRA) Research Performance Progress Report (RPPR) Submission Validations for Clinical Trial Registration and Results Reporting
NATIONAL INSTITUTES OF HEALTH (NIH)
This notice replaces NOT-OD-19-126. The purpose of this notice is to 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). 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 additional extension will last through September 24, 2023. During this extension period, NIH will continue to work with the BESH community to explore solutions that allow for the dissemination of information in ways that are useful to other researchers and members of the public, while also maintaining the NIH commitment to stewardship and increasing transparency.
In 2018, NIH issued a notice that delayed the enforcement of the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information for BESH through September 24, 2019 to accommodate potentially unique needs of this community. In 2019, NIH issued an additional notice of extension that delayed the enforcement for BESH through September 24, 2021. During this period of delayed enforcement, NIH continued to release funding opportunity announcements (FOAs) designated as “basic experimental studies with humans,” and engaged with the BESH community to more fully understand the challenges for dissemination of information about BESH.
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, through September 24, 2023. This delayed enforcement is only applicable to BESH studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title.
NIH recognizes that registering and reporting results in ClinicalTrials.gov poses a challenge for some types of BESH projects. NIH remains committed to working with the BESH community and will continue to explore solutions to facilitate the dissemination of information in ways that are useful to other researchers and members of the public, while also maintaining the NIH commitment to stewardship and increasing transparency. During the extension, NIH will continue to assess the needs of the BESH community as solutions are considered for BESH registration and results reporting.
During this time, NIH continues to expect registration and results reporting, 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 BESH-specific FOAs 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 prospective basic science studies involving human participants. 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 basic science studies involving human participants 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 Frequently Asked Questions (FAQs) and Special Considerations for BESH webpage.
NIH Grants Information