Dear Colleagues:
I wanted to provide an update on applications, registration, and reporting requirements for NIH and NIH-funded researchers conducting basic experimental studies with humans (BESH). NIH has been working closely with the research community to provide clarification on these requirements and listen to concerns. While the application process for these studies remain unchanged, NIH is extending flexibility for registering and reporting these studies in alternative platforms for an additional two years while we further explore ways to disseminate information about such studies in ways that are scientifically meaningful. You can read more about the extension in my most recent Director’s Blog, co-authored by Drs. Carrie Wolinetz and Michael Lauer.
We look forward to continued work with the community as we implement the suite of initiatives launched in 2016. These efforts are designed to ensure that NIH and NIH-funded scientists maximize stewardship and transparency of NIH-supported clinical trials, and fulfill our ethical mandate to volunteers participating in research.
Sincerely,
William T. Riley, Ph.D.
Associate Director for Behavioral and Social Sciences Research
Director, Office of Behavioral and Social Sciences Research
National Institutes of Health