The document outlines the National Institutes of Health’s (NIH) next steps regarding the application and enforcement of clinical trial policies for basic science studies. For all trials not classified as basic science, NIH will continue with existing policy enforcement. However, for basic science studies, NIH will delay the enforcement of the policy on registration and reporting, originally posted in the Federal Register on September 16, 2016, until July 1, 2019. During this period, NIH will adopt a lenient and flexible approach, emphasizing monitoring and refinement rather than penalization. The organization seeks to enhance stewardship, transparency, and ethical responsibility in all human trials, while acknowledging differences between clinical and basic science trials. NIH expects ongoing registration and reporting for basic science trials, with the flexibility to use suitable existing portals and the eventual transfer of data to clinicaltrials.gov.
Additionally, in response to a congressional directive, NIH will issue a Request for Information (RFI) to gather input from the basic research community regarding appropriate reporting standards for basic science research, with the RFI open for 90 days. NIH also plans to release a new parent funding opportunity announcement (FOA) specifically for fundamental human studies meeting the NIH definition of a clinical trial, with a commitment to increased transparency and recognition of unique challenges in basic science research, and the FOA is set to be published by October 30, 2018.
