Posting of Clinical Trial Consent Forms

THESE CHANGES APPLY TO NON-EXEMPT RESEARCH.

This is a new requirement that requires posting of clinical trial consent forms within a defined time period on a publicly accessible website. MSU plans to only require this when research is conducted or supported by a Common Rule department or agency that must comply with the 2018 requirements.

• Posting of Clinical Trial Consent Form

  "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)

• Summary of Changes
  Requirement
  

  • This section requires that:
    • for clinical trials
    • conducted or supported by a Common Rule department or agency,
    • a copy of an IRB-approved version of a consent form
    • that was used to enroll subjects
    • would need to be posted
    • by the awardee or the federal department or agency conducting the trial
    • on a publicly available federal Web site that will be established as a repository for such forms.
      
      

  Version

  • 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.
  • 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.
    
    

  Multi-Institution Studies

  • Only one posting would be required for each multi-institution study.
    
    

  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.
    
    

  Time Period

  • The posting 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).

   

  Location

  • The Office of Human Research Protections (OHRP) announced that these consent forms must be posted either on clinicaltrials.gov or to a docket folder on regulations.gov (docket ID: HHS-OPHS-2018-0021).