Submit comments and share with APA for inclusion in APA’s response.
The National Institutes of Health (NIH) has taken two steps this summer toward clarifying and possibly revising its recent policy that would include basic research conducted with humans within its definition of clinical trials and would impose requirements designed for clinical trials on the registration and reporting of basic research.
On July 20, the NIH issued a Guide Notice (NOT-OD-18-212) explaining its plan to loosen enforcement for basic research projects of clinical trials registration and reporting requirements through September 24, 2019. (See previous report.)
Next, on August 10, NIH released a Request for Information (RFI), NOT-OD-18-217. The RFI asks for responses in the following areas:
“Specific examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
“Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
“Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
“Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
“Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.”
Scientists should submit their comments to NIH by the deadline of November 12, 2018. See the RFI for instructions on submitting comments.
The American Psychological Association will also submit comments in response to the RFI. Scientists are encouraged to share their ideas with Pat Kobor (firstname.lastname@example.org) of APA’s Science Government Relations Office by November 5, 2018, so that APA’s response reflects your views.
Please encourage your colleagues to respond as well. APA aims to ensure that NIH hears a range of persuasive comments to prompt a change in a policy that is sowing confusion among basic scientists.