Posting Clinical Trial Informed Consent Form

Requirement

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The posted consent form must have been used in enrolling participants.

For additional information and instructions for posting, visit the OHRP website.

This requirement applies to:

*research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes

Additional 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.
  • Federal departments or agencies may permit or require redactions, as appropriate.

When to Post

After the study is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

Where to Post

At this time, there are two publicly available federal websites that will satisfy the consent form posting requirement:

1. www.ClinicalTrials.gov  

This may be the easiest choice if the study is already registered to Clinicaltrials.gov. Specific instructions on how to register with ClinicalTrials.gov and upload documents (including consent forms) can be found on the www.ClinicalTrials.gov.If you have already registered your study, see Appendix A.1 of the ClinicalTrials.gov Results Data Elements Definitions document for information on posting the consent form.

2. www.Regulations.gov  

Upload the consent form to docket folder HHS-OPHS-2018-0021 by following the instructions located on the

Clinical Trial Informed Consent Form Posting webpage of the federal Office of Human Research Protections.

Be sure to save a copy of your Regulations.gov receipt.

Additional References

ClinicalTrials.gov:

If you need assistance, please contact Jordan Wilkinson, Office of the Vice Provost for Research, Research

Administration & Development division, Jordan.Wilkinson@tufts.edu or (617) 636-6754.