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.
Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants - Notice Number: NOT-OD-21-088