ARVO leadership recently responded to the National Institutes of Health’s redefinition of clinical trials in a letter expressing concern regarding the potential for broad interpretation of the new definition and its resulting impacts on eye and vision scientists. The letter, drafted by the ARVO Ethics and Regulations in Human Research (ERHR) Committee, was posted on the ARVOConnect Open Forum by ARVO President Claude F. Burgoyne, MD, FARVO.
The letter stated, “Many member scientists conduct basic research, using humans as experimental observers. These studies are not 'clinical trials' in the conventional usage and common understanding of the term; but the new NIH definition could put that label on a substantial body of work in our field.”
The ARVO leadership echoed “concerns expressed by others that classifying basic human research as clinical trials can confuse the public about the nature of trials and that the additional studies categorized as trials will place additional and undue burden on NIH oversight, on researchers and their institutions ….” In addition, the leadership shared it concerns “that the grant review process will be significantly disrupted by the requirement that beginning with the January 25, 2018 grant due dates, all applications proposing clinical trials must be submitted through a FOA designated specifically for clinical trials."
Visit ARVOConnect to read the letter in its entirety and to participate in the members-only discussion on the topic.