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:

Do I need to include a Dissemination Plan in my grant proposal?
Yes. Any NIH application with a clinical trials component must include a Dissemination Plan. The plan must assure the reviewers that:

    • 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.

Do I need to register and submit results for my trial on ClinicalTrials.gov?
All NIH-funded trials are now required to register and submit results on ClinicalTrials.gov. For more information, refer to NIH’s Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov. UofL recommends registration prior to first-patient-enrollment in order to ensure compliance with this policy.
Do I need to address clinical trials in my RPPR?
Yes; for additional guidance please refer to the NIH Research Performance Progress Report Guide (PDF).