The Revised Common Rule (RCR) requires federally conducted or supported clinical trials to post a consent form on a publicly available federal website. Because this requirement is new, we’re still figuring out how it works in practice. Here’s some information that may help.
First, the RCR’s definition of a clinical trial is: 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. [45 CFR 46.102(c)].
One IRB-approved consent form must be posted. That requirement means you don’t have to post every single version that was approved, but only one, but the version you post must have been used to enroll subjects [45 CFR 116(h)(1)].
The consent form must be posted on the website after the clinical trial is closed to enrollment, and no later than 60 days after the last study visit by any subject [45 CFR 46.116(h)(3)].
So far, the two federal websites designated as appropriate places to post consent forms to meet this requirement are clinicaltrials.gov and a docket folder on regulations.gov. OHRP says instructions and other materials related to this posting requirement are in development. Some information about this requirement is now available on OHRP’s website as well.
What’s the rationale for this requirement? Well, we’re not entirely sure. As the posting will happen after studies are closed to enrollment, it can’t be intended as a recruitment aid. One potential motivation is that, because these studies are publicly funded, OHRP wants to make sure the public can access information about the studies they are supporting. We’ve also heard that OHRP wants to make it easier for IRBs and human research protection programs to learn from each other about consent form practices by making these forms available.