All new studies approved by the IRB on or after January 21, 2019 must comply with the Revised Common Rule. One addition to the Revised Common Rule is a requirement to post an informed consent form used to enroll subjects on a publicly available website. This requirement applies to all federally funded clinical trials.
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.
Which studies are subject to this new requirement?
The requirement applies to all federally funded clinical trials including social, behavioral or educational (SBER) research studies that meet the definition of a clinical trial.
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.
Who is responsible for posting?
The posting requirement is the responsibility of the awardee. For federally funded projects where the University of Pittsburgh is the only awardee, the University of Pittsburgh Principal Investigator 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.
Where must the consent form be posted?
The consent form must be posted on a publicly available website approved for such posting. The Office of Human Research Protections (OHRP) issued guidance that two publicly available federal websites have been identified that will satisfy the consent form posting requirement:
- A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).
Please note: For studies that are registered on ClinicalTrials.gov, the consent form must be posted on ClinicalTrials.gov.
When should the consent form be posted?
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.
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 consent form version 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.
Can any information be redacted from the consent form prior to posting?
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.
Are there any requirements I should be aware of when posting a consent form on 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.
For additional guidance contact Clinical Trial Registration & Transparency Support at CTgov@pitt.edu.
Are there any requirements I should be aware of when posting a consent form to the Docket Folder on Regulations.Gov?
To use regulations.gov to satisfy the 45 CFR 46.116(h) requirement, you must submit the informed consent form as a comment to the appropriate docket folder (Docket ID: HHS-OPHS-2018-0021).
OHRP has released new instructions for posting consent forms to this folder called Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))