Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Posting Informed Consent Forms for Clinical Trials

This page explains when and how informed consent forms must be posted for certain NIH clinical trials under the Revised Common Rule (45 CFR 46.116(h)).

Important: This guidance applies to the NIH Intramural Research Program (IRP). It may be updated if NIH or OHRP issues new policy or guidance.

Overview

Under the Revised Common Rule, certain clinical trials must post one IRB-approved informed consent form on a public Federal website.

This requirement applies to:

  • Clinical trials conducted or supported by a Federal department or agency (including NIH), and
  • Research reviewed under the 2018 Revised Common Rule requirements.

A consent form must be posted if the study:

  • Meets the regulatory definition of a clinical trial, and
  • Is conducted or supported by a Federal department or agency.

Under the regulation, a clinical trial is:

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects on biomedical or behavioral health-related outcomes.

If your NIH study meets this definition, the posting requirement applies.

  • One (1) IRB-approved informed consent form
  • The form must have been used to enroll participants
  • It does not have to be the final version
  • For multi-site trials, only one consent form must be posted (not one per site)

The regulation does not specify:

  • Which version must be posted
  • Whether it must be the most recent version
  • That each site must post separately

Only one IRB-approved consent form used to enroll subjects is required.

The consent form must be posted:

  • After the clinical trial closes to new enrollment, and
  • No later than 60 days after the last study visit by any subject, as required by the protocol.

Important Clarifications

  • The deadline is based on the last participant’s final study visit, not overall study closure.
  • Study closure (for example, after data analysis is complete) is not the trigger.
  • If an IRB terminates a study or closes it to enrollment early, the 60-day clock still applies.
  • Posting is required even if enrollment stops early.

The consent must be posted on a publicly available Federal website that serves as a consent form repository.

OHRP has identified the following acceptable websites:

  • ClinicalTrials.gov
  • Regulations.gov

At NIH, consent forms should be posted to ClinicalTrials.gov.

Yes, but only in limited circumstances.

If the Federal department or agency determines that certain information should not be made public (for example, confidential commercial information), redactions may be permitted or required.

However:

  • The regulation does not allow exceptions to posting.
  • It only allows specific information to be redacted when appropriate.

At NIH:

  • The Principal Investigator (PI) is responsible for ensuring the consent form is posted on time.
  • The PI should work with their Institute or Center (IC) if questions arise.

The purpose of posting informed consent forms is to:

  • Increase transparency
  • Improve the quality and clarity of consent documents
  • Help participants and families better understand research