Posting Clinical Trial Informed Consent Forms

Purpose

The purpose of this requirement is to be more transparent about the consent forms being used and, over time, improve the quality of consent forms.

Policy Implementation

Sections 46.102(b) and 46.116(h) of the revised Common Rule requires clinical trials post one IRB-approved version of a consent form that has been used to enroll participants on a public federal website designated for posting such consent forms.

The form must be posted after recruitment closes, and no later than 60 days after the last study visit.

Where to Post Informed Consent Forms

Currently there are two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule:

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.

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.

Notices

• NOT-OD-19-110: Guidance on Posting Informed Consent Forms for NIH-Funded Clinical Trials
• NOT-OD-19-050: NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)