Clinical Trial Informed Consent Form Posting

All Columbia clinical trials that are federally funded and initially approved by an IRB on or after January 21, 2019 must comply with the requirement of the Revised Common Rule (i.e., 2018 Rule or 2018 Requirements). One of these requirements is to post an unsigned copy of the IRB-approved consent form on a publicly available federal website. The requirement applies to all research that meets the definition of a clinical trial, including biomedical, social, behavioral and educational.

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.

The Revised Common Rule requires a consent form to be posted on a publicly available federal website within a specific time frame for any clinical trials* conducted or supported by a Common Rule department or agency (45 CFR 46.116(h)).

In order to satisfy this new provision, the following must apply:

  • The consent form must have been used in enrolling subjects.
  • Consent form is posted (1) after a study is closed to recruitment, and (2) where 60 or fewer days have passed since the last study visit (i.e., within 60 days from the last study visit).
  • An unsigned, IRB-approved stamped copy is posted on either or

*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. (DHHS 45 CFR 46.102(b))

Only ONE version of the consent form must be posted publicly for each clinical trial that meets the criteria listed above. The prime awardee is responsible for complying with the rule but another involved institution may post with written agreement of the prime awardee.

Currently, there are 20 Departments and Agencies that intend on following the Revised Common Rule (published January 2017, amended January 2018, effective July 2018). Please click here for the current listing of the Common Rule Departments and Agencies.

The general compliance date of the Revised Common Rule is January 21, 2019. This means that HHS-conducted or supported research initiated on or after January 21, 2019 will need to comply with the Revised Common Rule. The term "initiated" refers to the date on which:

  1. research was initially approved by an institutional review board (IRB);
  2. IRB review was waived pursuant to §46.101(i); or
  3. a determination was made that the research was exempt.


 Posting of an informed consent form in accordance with the Revised Common Rule is required if:  

  1. if the award supporting your study is funded by any of the Departments or Agencies listed here;
  2. the research was initiated on or after January 21, 2019; and
  3. the study is closed recruitment, and there are 60 or fewer days since the last study visit.

45 CFR 46.116(h)(1) requires that the version must be IRB-approved and have been used to enroll subjects. If there are multiple versions that meet these criteria, Columbia recommends that a more recent version is uploaded, as it is more likely to have the most up to date information about the study.  Only one consent form is required to be posted, even if different versions are used for each class of subjects in the study (e.g., adults and minors), for different consent situations (e.g., paper and electronic formats) or for each study site. If the consent form is revised after it has been posted and is used to enroll additional subjects, there is no requirement to replace the posted version.

If a clinical trial closes to recruitment 61 or more days after the last study visit by any enrolled subject as required by the protocol, OHRP recommends that an informed consent form be posted within 60 days of when the study is closed to recruitment. If a consent form is posted before the study is closed to recruitment, the posting will NOT satisfy §46.116(h).

If you have identified a study that requires posting of a consent form, please contact the IND/IDE Assistance Program (IAP) at [email protected] for guidance on how to comply.

When contacting the IAP, please have the following information available:

  • Protocol # (i.e., Rascal #)
  • Award type and grant #
  • Date of last study visit
  • ICF version to post
  • Corresponding protocol to ICF version being posted

For more information on the posting of consent forms, please visit the HHS website.