Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants.

Several organizations, including COGR, have expressed concern that the NIH clinical trial case studies broadened the agency’s definition of “clinical trial” to include basic science studies involving human participants. NIH, in response to report language in the Consolidated Appropriations Act of 2018, has released this notice (NOT-OD-18-212) which  delays enforcement of registration and reporting policies for prospective basic science studies involving human participants under NOT-OD-16-149 . Per the notice, “through September 24, 2019, NIH will continue to expect registration and reporting for prospective basic science studies involving human participants, with additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be transported to ClinicalTrials.gov.” NIH will issue a Request for Information (RFI) to seek additional input “on registration and results reporting standards best suited for prospective basic science studies involving human participants.”

The notice also provides a period of “leniency for applications submitted to the incorrect FOA based on the study type designation” during which time NIH will not “administratively reject any application for submission to an incorrect FOA based on study-type designation.” The notice also indicates that the agency “plans to issue FOAs specifically for prospective basic science studies involving human participants.” Please see the notice for details.