Posting of Consent Forms for Federally Funded Clinical Trials

The Revised Common Rule requires all clinical trials to post an unsigned informed 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.

Studies Subject to this Requirement

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

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.

Redaction

Any requests to redact certain information prior to posting must be submitted to the Federal department or agency supporting the clinical trial. Only the Federal agency supporting the clinical trial may permit or require redactions to the information posted.

Helpful Details

  • The consent form must be posted after recruitment closes, and no later than 60 days after the last study visit of any participant 
  • One IRB-approved (English) version of a consent form that has been used to enroll participants must be posted 
  • If the consent form is revised during the study, only one version of the consent form should be posted. 
  • If the study has a separate HIPAA authorization form, do not post the separate HIPAA authorization form. 

 

Posting Information

Who is responsible for posting?

Adherence to the posting requirement is the responsibility of the awardee. For federally funded projects where PSU is the only awardee, the Penn State PI bears the responsibility of ensuring the requirement for posting of the consent form is met.

When should the consent form be posted?

The informed consent form must be posted on the Federal Web site 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. For studies that are registered on ClinicalTrials.gov, the informed consent form should be uploaded at the same time the Overall Status is updated to reflect the trial is closed to recruitment.

Which version of the consent form should be posted?

The Revised Common Rule requires that the version of the consent document that is posted must a) be IRB-approved and b) have been used to enroll a participant in the clinical trial. The version of the consent that should be posted is the most recent IRB-approved version that was used to enroll a participant. The consent form should not be signed by a participant.

Where should the consent form be posted?

The consent form must be posted on a publicly available website approved for such posting.Two publicly available federal websites have been identified that will satisfy the consent form posting requirement. These include:

  • ClinicalTrials.gov
  • A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). 

For studies that are registered on ClinicalTrials.gov, the consent form must be posted on ClinicalTrials.gov.

When posting a consent form to ClinicalTrials.gov:

  • The document date entered must match the date of IRB approval as listed on the stamped consent form.
  • When uploading the consent form, it must have a cover page with the following elements: 

    • Study Title
    • Document Date [Date of IRB approval on the stamped consent form]
    • NCT number
    • The consent form and corresponding cover page must be saved in a PDF/A format for upload.

When posting a consent form to the Docket Folder on Regulations.gov refer to the instructions provided by OHRP on submitting informed consent forms.