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1.33 Posting of Clinical Trial Consent Forms

Last Revised: 9/18/20193/16/2026

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for posting of clinical trial consent forms, per requirements of 45 CFR 46.116(h).

2.0 Policy

  • 2.1. It is the policy of the Organization that, for nonexempt clinical trials (as defined below) conducted or supported by a Common Rule departmentagency, and initially approved by the IRB on or agency,after January 21, 2019, the awardee of a grant will post one IRB approved informed consent form used to enroll subjects onto aClinicalTrials.gov publicly(or availableother Federal Web site that will be establishedwebsite as adesignated repositoryby forOHRP) suchno informedlater consentthan forms.60 Posting shall occurdays 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.enrollment.

3.0 Definitions

  • 3.1. Clinical Trial (for the purpose of this Policy) 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 those interventions on health-related biomedical or behavioral outcomes.”outcomes” (45 CFR 46.102(b)).

4.0 Investigator Responsibilities

  • 4.1. If the UNMC/UNO/CHMC/BMCPrincipal investigatorInvestigator of a non-exempt clinical trial is faculty, student or staff of the Organization, and (1) is the awardee of the grant from a Common Rule agency or department, orOR (2) is the principal investigator of a multi-site clinical trial conducted by a Common Rule agency or department, then he/shethey isare responsible for posting the consent form as described in this policy.
  • 4.2. The PI must notify the ORA when the clinical trial is closed to recruitment.enrollment.
    • 4.2.1. Notification of the ORA can be in the form of:
      • 4.2.1.1. Direct communication from the study team (for example, through the RSS message portal)
      • 4.2.1.2. Notification from the Clinical Trial Management System when the last subject is accrued.
      • 4.2.1.3. At the time of Continuing Review when status changes to “Subject Accrual Completed”, provided enrollment ceased less than 60 days before the submission of the CR.
  • 4.3. The PI must post one IRB approved unsigned consent form to ClinicalTrials.gov (or other website as designated by OHRP) within 60 days of enrollment of the last subject. Note: 45 CFR 46.116(h) requires that a CF be posted “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 protocolprotocol.” (per 45 CFR 46.116(h)). In practice,However, the ORA requires thatearlier theposting consentas form be posted within 30 days of enrollment of the last subject.above.
    • 4.3.1. The consent form need not be the current version.
    • 4.3.2. If there are multiple consent forms, only one must be posted. That is, if there are different consent forms for different classes of subjects (for example, for adults and for minors), or for different phases of the research (for example, screening and intervention) or for different interventions in different groups (for example, for an investigational group and a control group) only one needs to be posted.
    • 4.3.3. 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 (for example, confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. Without such permission or requirement, the consent form must be posted as it had been approved.
    • 4.3.4. 4.4.Failure Theto PIpost mustconsent notifyforms in accordance with this policy constitutes noncompliance subject to actions as per HRPP policy 8.4 (Review of Noncompliance by the ORAPI, whenStudy theTeam, consentand/or form has been posted.Subjects)

5.0 ORA ProceduresResponsibilities

  • 5.1. At the time the ORA is notified that the clinical trial is closed to recruitment, the administrator will log the date into the RA database, andenrollment, the ORA will notify the investigator of the requirements and advise that consent form must be posted within 30 days.
    • 5.1.1. Notification of the ORA can come from the investigator (in the form of a completion report, or direct communication); from the Clinical Trial Management System (in the form of an automated notification when the last subject is accrued); or at the time of Continuing Review when status changes to “Subject Accrual Completed.”
  • 5.2. After 30 days the ORA will query the investigator to verifyconfirm that the consent form has been posted.posted Inas addition,described above, or will be posted within 60 days from the ORA may choose to review CT.gov to determine if consent form has been posted.
  • 5.3. Failure to report relevant events (per section 4.2 and 4.4), or to respond the ORA queries, constitute non-compliance subject to disciplinary actions as per HRPP policy #8.5.
  • 5.4. Failure to post consent forms as per section 4.3 constitutes serious non-compliance subject to disciplinary actions as per HRPP policy #8.5, and per the Officetime of thelast Vice-Chancellor for Research.enrollment.

DOCUMENT HISTORY:

 Written: 2/27/2019 (Approved: 2/27/2019) - original author not recorded

 Revised: 9/18/2019 - revision not documented

 Revised 3/16/2026 - Revised to delete procedures more appropriate for SOP; clarified that policy applies to nonexempt clinical trials conducted or supported by a Common Rule agency, and initially approved by the IRB on or after January 21, 2019; revised throughout to state that CF posting must occur within 60 days of last subject accrual; clarified methods that ORA can be notified of closure of enrollment; deleted requirement that research team notify ORA that CF has been posted; stylistic changes.

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