Clinical trials in the research community are subject to strict ethical and regulatory requirements. For instance, in the U.S., researchers must register clinical trials and report the results on ClinicalTrials.gov. Recently, National Institutes of Health (NIH), the largest funding agency of clinical trials in the U.S., changed the “clinical trial” definition. The policies that were initially implemented only in biomedical clinical trials will now be equally applicable to social sciences and behavioral sciences intervention trial. This expanded definition of a clinical trial is the subject of a recent controversy.
These requirements intend to distinguish clearly between a clinical trial and a clinical research study. This change will promote scientific transparency and accountability in data collection, tracking, and reporting results. Nevertheless, why these new policies are unacceptable to some of the researchers?