Changes Applicable to Clinical Trials – 2018 Common Rule

If your study meets the definition of a Clinical Trial
you will be required to post one IRB-approved version of the consent
used in your study to consent subjects on a federal public website.

Clinical Trial Definition (45 CFR 46.102(b)):
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 the interventions on biomedical or behavioral health-related outcomes.

  • Required Posting of Consents from Clinical Trials
    • Must be posted after the clinical trial is closed to recruitment, but no later than 60 days after the last study visit by any subject.
    • Must be an IRB-approved version of the consent that was used to consent subjects in the trial.
    • Need to post only one regardless of how many different versions were used in the trial.
    • The awardee of the federal funding or support is the entity responsible for posting or the Federal department or agency conducting the trial.
    • Research teams will be responsible for posting consents in the appropriate time frame or communicating with their federal department or agency regarding who is responsible for the posting.
    • Current sites for posting include