NIH Enhancing its Clinical Trial Stewardship
The U.S. National Institutes of Health (NIH) is implementing a series of administrative changes to enhance its stewardship of clinical trials by increasing the rigor and transparency of research it funds. Most changes go into effect January 25, 2018.
These initiatives, which target key points along the clinical trial life cycle, include:
- Development of a new funding opportunity template specifically for clinical trials
- Adoption of the FORMS-E Application, consolidating all human subjects and clinical trial-related information into one form
- Updated peer review criteria of clinical trial applications
- Use of a single IRB to review a multi-site research protocol
- Reporting of final results in ClinicalTrials.gov. to ensure data from federally funded trials can be stored in a public database for use by other scientists.
These changes impact how NIH funding opportunities for clinical trial research will be approached, going forward. Refer to the NIH clinical trial web page for related updates, training opportunities, and helpful resources to stay informed.