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FASEB Reiterates Concerns with NIH Clinical Trials Policy

Thursday, November 15, 2018

On November 8, FASEB submitted comments in response to a Request for Information (RFI), "Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants." FASEB's comments focused on the second topic, "strengths and weaknesses of potential alternative platforms," and specifically highlighted ways in which the NIH RePORTER system could be utilized for those studies not meeting the criteria for applicable clinical trials as outlined in the Food and Drug Administration Amendments Act of 2006.

In addition to the comments submitted through the RFI website, FASEB also sent a letter to NIH leadership reiterating previously articulated concerns with NIH's expanded definition of clinical trials and potential unintended consequences of this change on research activities, investigators, and institutions.