Posting Clinical Trial Consent Forms

The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, 2019. This is a requirement for studies meeting the definition of a clinical trial and funded by a Common Rule department or agency, which includes NIH and NSF.  

The goal of this requirement is to increase transparency for federally funded clinical trials and simultaneously create a repository of sample consent forms that may be used as a reference for future research.

This requirement applies to all federally funded clinical trials that meet the definition of a clinical trial (see 45 CFR 46.102(b)). This includes social, behavioral, or educational (SBER) research studies.

A 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.

Adherence to the posting requirement is the responsibility of the awardee. For federally funded projects where RIT is the only awardee, the RIT PI bears the responsibility of ensuring the requirement for posting of the consent form is met. For multi-site research, generally the prime awardee is considered the responsible party and must ensure compliance with the posting requirement.

The informed consent form must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. The most recent IRB-approved version that was used to enroll a participant should be used.

There are two publicly available federal websites that will satisfy the requirement:

1. ClinicalTrials.gov
   • You can upload an IRB-approved version of the form to the ClinicalTrials.gov study record. Note that ClinicalTrials.gov does not accept non-English documents.
   • Be sure to follow the Protocol Registration and Results System (PRS) instructions for document uploads.
2. Regulations.gov
   • You can upload an IRB-approved version of the form to Regulations.gov Docket ID: HHS-OPHS-2018-0021.
   • Instructions for uploading can be found on the OHRP website.
   • Be sure to maintain a copy of your Regulations.gov receipt