As previously reported, the National Institutes of Health (NIH) has been taking steps in recent years to enhance its stewardship of and increase transparency over the clinical trials it funds. This has included the development of a new, expanded definition of the term “clinical trial,” which now applies to all research involving human subjects that involves a prospective experimental manipulation of an independent variable, and triggers the need for researchers to adhere to a number of new registering and reporting requirements using clinicaltrials.gov (see COSSA’s Hot Topic piece for details). Many basic behavioral and social science studies will be caught up in these new requirements.
NIH released a Request for Information (RFI) (NOT-OD-18-217) in September seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants (see COSSA’s previous coverage of the RFI). COSSA has issued an Action Alert to assist stakeholders concerned about this revised “clinical trials” definition in responding to the RFI. The alert includes additional context on the NIH clinical trials policy, a step-by-step guide to responding to the RFI, and sample text respondents can use in submitting their comments. Responses to the RFI are due by November 12, 2018. COSSA encourages individuals concerned about this policy to respond and share the action alert widely.