The Revised Common Rule requires a consent form to be posted on a publicly available federal website within a specific time frame for any clinical trials* conducted or supported by a Common Rule department or agency (45 CFR 46.116(h)).
In order to satisfy this new provision, the following must apply:
- The consent form must have been used in enrolling subjects.
- Consent form is posted (1) after a study is closed to recruitment, and (2) where 60 or fewer days have passed since the last study visit (i.e., within 60 days from the last study visit).
- An unsigned, IRB-approved stamped copy is posted on either ClinicalTrials.gov or Regulations.gov.
*Clinical Trial is defined 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 the interventions on biomedical or behavioral health-related outcomes. (DHHS 45 CFR 46.102(b))
Only ONE version of the consent form must be posted publicly for each clinical trial that meets the criteria listed above. The prime awardee is responsible for complying with the rule but another involved institution may post with written agreement of the prime awardee.
Currently, there are 20 Departments and Agencies that intend on following the Revised Common Rule (published January 2017, amended January 2018, effective July 2018). Please click here for the current listing of the Common Rule Departments and Agencies.