Do You Have NIH Funding? Is Your Human Subjects Research Study Interventional? If Yes, You are Probably Required to Submit Results to ClinicalTrials.govMay 13, 2021
The “NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information” requires investigators/awardees conducting clinical trials to ensure that these trials are registered, and that results information is submitted to ClinicalTrials.gov if:
- The clinical trial is funded in whole or in part by NIH; and
- The application for funding (e.g. grant application) for the clinical trial was submitted to NIH on or after January 18, 2017; and
- The clinical trial being funded was initiated on or after January 18, 2017.
NIH defines a clinical trial as: “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 interventions on health-related biomedical or behavioral outcomes.”
The policy applies to clinical trials funded in whole or in part by the NIH regardless of:
- study phase,
- type of intervention
- whether or not they are subject to the regulatory requirements for registration and results posting described in the statute* and/or the rule**
- whether the study terminated early or concluded according to the protocol
Where required, results must be posted within 1 year of the Primary Completion Date (the last visit date where data was collected for the primary study outcome measure). If registration and results reporting requirements are not met, NIH may take grants enforcement actions, including denial of future funding and funds recovery actions.
For help reporting results to ClinicalTrials.gov, contact email@example.com.
* Section 402(j) of the Public Health Service Act, as amended by Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA)
**42 CFR Part 11: “Clinical Trial Registration and Results Information Submission”