As NCFR has previously shared, the National Institutes of Health (NIH), in an effort to improve its transparency and stewardship over the clinical trials it funds, has developed a new, expanded definition of the term clinical trial.

According to this definition, 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 (read the full details). Many basic behavioral and social science studies will be caught up in these new requirements.

In August, the NIH released a Request for Information (RFI) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants.

The Consortium of Social Science Associations (COSSA), of which NCFR is a member, has provided a step-by-step guide and  sample response to assist stakeholders who wish to respond to the RFI. 

All comments must be received by Nov. 12, 2018.

Respond to RFI