NIH Proposes New Requirements for Clinical Trials; Public Comment Period Closes November 12
NIH Proposes New Requirements for Clinical Trials; Public Comment Period Closes November 12

October 2018

The National Institutes of Health (NIH) is currently accepting comments on proposed reporting and registration requirements for “prospective basic science studies involving human participants.” Comments are due on November 12. The Consortium of Social Science Associations, of which AERA serves as a governing association, has issued an action alert to encourage social and behavioral scientists to submit comments.

NIH expanded the definition of a clinical trial to include basic research funded by the agency that encompasses studies involving human subjects assigned to an “intervention.” In response to advocacy from the brain, social, and behavioral science communities, Congress included language in the FY 2018 omnibus package requiring that NIH delay its enforcement of the policy for “fundamental research involving humans” and submit to Congress a plan to gather input from the research community.  Scientists who receive funding for basic research support NIH’s efforts to promote research transparency, but have expressed concerns about the classification of basic, fundamental research as clinical trials.

NIH announced an enforcement delay of the clinical trial policy for prospective basic science studies involving human participants to September 24, 2019. This allows basic scientists working with human participants to submit their proposals for a specific study-type funding announcement without the application being rejected for applying as a non-clinical trial instead of a clinical trial. NIH also released a notice of intent for funding opportunities for basic studies involving human participants, which will be released in late November with a deadline of January 21, 2019 for applications.

AERA joined 25 organizations on a letter to NIH Director Francis Collins regarding the implementation of the expanded definition of clinical trials in October 2017. Brett Miller, program director at the National Institute of Child Health and Human Development, noted the impact of the changes in the NIH clinical trial policy for education researchers in his January 2018 Highlights Q&A.

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