Broad changes have been made to the NIH’s regulatory process for clinical trials, beginning with a new definition published in 2014. This new definition includes studies that evaluate effects of “interventions” such as “manipulation” of environment on “behavioral outcomes.” Many behavioral research studies will now be classified as clinical trials and will be subject to new requirements, including new standards for funding requests and a requirement to post results on clinicaltrials.gov. A statement from the NIH in September 2016 goes further to mandate new training for trial staff and clarifies that all studies up for approval must adhere to a rigorous standard of evaluation of the study’s rationale and statistical design.
Science Magazine online reports that members of behavioral and brain research groups like the Association for Psychological Science (APS) and the Federation of Associations in Behavioral & Brain Sciences (FABBS) have voiced concern that many researchers may not be familiar with the new formal funding opportunity announcement (FOA) requirement, leading the NIH to reject their applications and force them to miss out on funding. Once an application is accepted for review, the new criteria used to evaluate a clinical trial might not apply to the proposed research. Other concerns include a bogging down of clinicaltrials.gov for patients searching for current studies and inclusion of many basic science studies that would result in wasted resources.
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