1.33 Posting of Clinical Trial Consent Forms

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 clinical trials conducted or supported by a Common Rule department or agency, the awardee of a grant will post one IRB approved informed consent form used to enroll subjects on a publicly available Federal Web site that will be established as a repository for such informed consent forms. Posting shall occur 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.

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.”

4.0 Investigator Responsibilities

4.1. If the UNMC/UNO/CHMC/BMC investigator is the awardee of the grant from a Common Rule agency or department, or is the principal investigator of a clinical trial conducted by a Common Rule agency or department, then he/she is 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.
4.3. The PI must post one IRB approved unsigned consent form to ClinicalTrials.gov (or other website as designated by OHRP) 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 (per 45 CFR 46.116(h)). In practice, the ORA requires that the consent form be posted within 30 days of enrollment of the last subject.
- 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.
- 4.4. The PI must notify the ORA when the consent form has been posted.

5.0 ORA Procedures

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, and 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 verify that the consent form has been posted. In addition, 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 Office of the Vice-Chancellor for Research.

DOCUMENT HISTORY:

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

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

1.1 Human Research Protection Program (HRPP)

1.2 Authority Granted to the IRB by the Organization

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

1.4 UNMC Ceding Review to an External Central IRB

1.5 Requirements for Research Conducted with International Sites

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

1.8 Investigational Activities Requiring IRB Review and Approval

1.9 Resources Necessary to Protect Subjects

1.10 Scientific and Other Committee Review of Research

1.11 HRPP Access to Legal Counsel

1.12 Sponsored Research

1.13 Compliance with ICH-GCP Guidelines

1.14 Research Subject to Department of Defense Regulatory Requirements

1.15 Research Subject to Department of Justice Regulatory Requirements

1.16 ORA Record Keeping Requirements

1.17 Retention of Research Records

1.18 Review and Approval of HRPP Policies and Procedures

1.19 IRB Signature Authority

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

1.21 Post-Approval Monitoring of Research

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.23 HRPP Training Requirements

1.24 HRPP Training Requirements for IRB Members

1.25 Financial Conflicts of Interest

1.26 PI Qualifications and Responsibilities

1.27 Research Personnel Qualifications and Responsibilities

1.28 External Investigator Assurance

1.29 ClinicalTrials.gov Reporting

1.30 Use of the Rapid Response IRB

1.31 Observers at IRB Meetings

1.32 Confidentiality of the Review Process

1.33 Posting of Clinical Trial Consent Forms

1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs

2.1 Submission for Items for Review by the IRB

2.2 Full IRB Review

2.3 Expedited Review

2.4 IRB Review of Changes in Previously Approved Research

2.5 Criteria for IRB Approval

2.6 Exempt Research

2.7 Continuing Review of Research

2.8 Limited IRB Review

2.9 Closure of On-Going Research

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

3.2 Data and Safety Monitoring

3.3 Privacy Interests and Confidentiality of Research Data

3.4 Use of Protected Health Information in Research

3.5 Subject Recruitment Through Advertisements

3.6 Subject Recruitment Through Direct Invitation

3.7 Finder’s Fees and Recruitment Bonuses

3.8 Research Subject Compensation and Reimbursement

3.9 Contraception Requirements

3.10 Pregnancy Testing

3.11 Collecting Data from Pregnant Partners of Research Subjects

3.12 Ethical Access

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

3.14 Phase I and First-in-Human Studies

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

4.1 Additional Protections for Vulnerable Populations

4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

4.3 Research Involving Prisoners

4.4 Research Involving Children

4.5 Local 407 Panel Review of Pediatric Research

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

4.7 Research Involving Employees of the Organization and Students as Subjects

5.1 Obtaining Informed Consent From Research Subjects

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

5.3 Use of a Remote Consent Process

5.4 Waiver of Requirement to Obtain Signed Consent Form

5.5 Use of the Short Form Consent Document

5.6 Exceptions from Informed Consent Requirements for Emergency Research

5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

6.1 Research Involving Investigational and Marketed Drugs

6.2 Research Involving Investigational and Marketed Devices

6.3 Humanitarian Use Device (HUD)

6.4 Emergency Use of a Test Article

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

7.1 Banking Human Biological Material

7.2 Use of Human Biological Material in Research

7.3 Data Registries