NIH Clinical Trials Initiatives
The Clinical Trial Requirements for Grants and Contracts webpage provides an overview of all initiatives undertaken by the NIH to promote accountability and transparency in clinical trial research. Several key items are discussed below:
- the clinical trial(s) under the award will be registered and results information submitted to ClinicalTrials.gov pursuant to NOT-OD-16-149;
- informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov; and
- the University has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements. Please reference the ClinicalTrials.gov Registration web page when making this assurance.
Note: If your human subjects study meets the definition of "Delayed Onset," include the dissemination plan in the delayed onset study justification.