New requirement for registering NIH-funded clinical trials on clinicaltrials.gov

On January 18, 2017, an expanded policy of the National Institutes of Health (NIH) goes into effect that requires that clinical trials funded in whole or in part by the NIH are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov. When applying for IRB approval, you still need to provide the IRB with the National Clinical Trial number (NCT#) if your study meets the definition of a clinical trial. Please see below for the NIH definition of a “clinical trial”:

Clinical Trial:  A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those intervention on health-related biomedical or behavioral outcomes.

Of note, this requirement for registering and results reporting includes clinical trials beyond those already required by the FDA. The requirements are expanded to include to Phase I drug studies and NIH-funded clinical trials of social-behavioral interventions. In addition to registration requirements, compliance with requirements for regular updates and results reporting within 12 months of study closure will become mandatory.

For more information on this policy please refer to:

• NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
• Checklist
• NIH Definition of Clinical Trial

You may also contact the IRB at the Charles River Campus (617-358-6115, irb@bu.edu) or the Medical Campus (617-638-7207, medirb@bu.edu) with questions.