Notice Number: NOT-OD-19-126
Release Date: July 24, 2019
NOT-OD-22-205 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants
National Institutes of Health (NIH)
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 extension will last through September 24, 2021. During this extension period, NIH will continue implementation of initiatives launched in 2016 aimed at assuring that NIH and NIH-funded scientists maximize stewardship and transparency. However, delayed enforcement for BESH registration and results reporting will allow NIH to engage in further conversations with the BESH community to gain a deeper understanding of the scientific and technical needs to best facilitate (in a least burdensome way) registration and reporting of BESH studies while ensuring this information is scientifically useful.
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. During this period of delayed enforcement, we also released a series of parent funding opportunity announcements (FOAs), designated as “basic experimental studies with humans”, specifically targeted for the subset of clinical trials that also meet the definition of basic research. NIH also released a Request for Information (NOT-OD-18-217) to collect feedback on registration and results reporting standards best suited for BESH. Feedback from the community overwhelmingly supported the goals and values stated in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information and provided insight into the types of studies and specific ClinicalTrials.gov data elements that pose the greatest challenges for registering and reporting for BESH, as well as potential alternative platforms for reporting such studies.
Extension of Some Flexibilities for BESH
NIH recognizes that registering and reporting results in ClinicalTrials.gov may pose a challenge for some types of BESH. We are committed to working with the 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.
To allow the necessary time to more fully understand the challenges for dissemination of information about BESH, NIH is extending the period of delayed enforcement for registration and results reporting, originally announced in NOT-OD-18-212, through September 24, 2021. 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 that BESH summary results will eventually be transferred into ClinicalTrials.gov. This delayed enforcement is only applicable to BESH studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title.
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. 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.
NIH will not be extending the leniency for applications submitted to the incorrect FOA based on the study-type designation. Starting for due dates on or after September 25, 2019, applications submitted to an incorrect FOA based on study-type designation (e.g., a clinical trial submitted to a “clinical trial not allowed” FOA) may be withdrawn.
For more information, please visit our Frequently Asked Questions (FAQs) webpage.
Please direct all inquiries to:
NIH Grants Information