On January 25, 2018 the National Institutes of Health (NIH) is implementing new policies related to clinical trials. Researchers whose proposed work meets the expanded definition of “Clinical Trials” will be required to do the following:
- Apply for funding via Funding Opportunity Announcements (FOA) specifically for clinical trials.
- Provide additional information in proposals. A “new Human Subjects and Clinical Trial Information form will be included in grant application packages and contracts for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates”
- Register and maintain studies in ClinicalTrials.gov
- Complete Good Clinical Practices education
The definition of clinical trials encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. Some Human Subjects Research previously not considered to be clinical trials is now categorized as such.
NIH provides guidance and a tool to help determine whether a study is considered to be a clinical trial by NIH. See NIH’s webpage on the definition that includes case studies, FAQs and other resources that can help. ORIC is also available to assist researchers. Determinations need to be made prior to proposal submission so this analysis should be completed well in advance of submission deadlines.
Registration for ClinicalTrials.gov is available by contacting ORIC at 412-268-7166 or emailing Susan Brunner at email@example.com.
Education on Good Clinical Practices is available through CMU. Details are forthcoming.