MSU HRPP Manual Section 6-4-F
Posting of Clinical Trial Consent Forms
Revised Common Rule (2018 Requirements)
“Posting of clinical trial consent form.
(1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.
(2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
(3) The informed consent form must be posted on the Federal Web site 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. ” 45 CFR 46.116(h)(2018 Requirements)
“Clinical trial means 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.” 45 CFR 46.102(b)(2018 Requirements)
For studies subject to the Revised Common Rule (2018 Requirements), for each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal Web site. Posting of clinical trial consent forms is only required for studies subject to the revised Common Rule (2018 requirements) and funded or supported by a Common Rule department or agency.
Consent Form Version
One IRB-approved consent form that was used for enrollment purposes must be posted.
There is no restriction as to which version of a consent form (which might have been subject to many modifications over the course of time) must be posted. Unless otherwise required by the Common Rule department or agency, there is no expectation that a version would need to be posted for each class of subjects in the study (for example, a posting both for adults and for minors), nor for each study site.
Posting Responsibility
The awardee or the Federal department or agency component conducting the clinical trial is responsible for fulfilling the requirements to post the clinical trial consent form. If Michigan State University is the primary awardee on a clinical trial conducted or supported by a Federal department or agency, the Principal Investigator is responsible for fulfilling the requirements to post the clinical trial consent form unless otherwise determined by the Federal department or agency component conducting the clinical trial. For a multi-institution study, only one posting would be required. The study team is expected to work with their collaborators to determine which IRB-approved consent form will be posted. However, if MSU is the primary awardee, the MSU PI remains responsible for assuring that the requirements for posting the clinical trial consent form have been met, even if the consent will be posted by a collaborator.
Redaction
If the federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a federal Web site (e.g., confidential commercial information), the department or agency may permit appropriate redactions to the information posted. In rare instances, it could be the case that the federal department or agency would determine that the very existence of a particular clinical trial should not be publicly disclosed, in which case no posting relating to such a trial would be required. Any redaction or determination that the very existence of a particular clinical trial should not be publicly disclosed must be made by the federal department or agency conducting or supporting the clinical trial; this determination cannot be made by the study team.
Timing
Posting of the clinical trial consent form can take place any time after the trial is closed to recruitment, so long as the posting is no later than 60 days after the last study visit by any subject (as required by the protocol).
Publicly Available Federal Website
The federal department or agency conducting or supporting the clinical trial determines the publicly available Federal website(s) to be used to satisfy the posting requirement. Currently, the clinical trial consent form could be posted to either clinicaltrials.gov or a docket folder on www.regulations.gov (docket ID: HHS-OPHS-2018-0021). However, it is possible that a website may be developed by the federal departments or agencies, or that a particular federal department or agency may require a different publicly available website.
Compliance Office
The Human Research Protection Program Compliance Office will work with the study team to identify whether a study is a clinical trial subject to the posting requirement and if so, to help assure that the posting requirements are met. This may include a Teaching Education and Compliance Help (TEACH) visit. See HRPP Manual 3-3 “Evaluation and Quality Improvement” for more information about TEACH.
Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements)” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.
This policy and procedure supersedes those previously drafted.
Approved By: Senior Vice President for Research and Innovation, 1-18-2019.