Institutional Approval of New Clinical Research Projects Policy

University Policy

Title

University of North Carolina at Chapel Hill Policy on Institutional Approval of New Clinical Research Projects

Introduction

Purpose

This policy establishes the requirements for activating new Clinical Research projects at the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”). The policy ensures research teams meet federal, state, and institutional requirements before initiating participant enrollment or data collection.

Scope

Policy

Principal Investigators are prohibited from enrolling participants or collecting study data for any Clinical Research project covered by this policy until the University has issued Institutional Approval to proceed. Institutional Review and Approval will be granted by the Office of the Vice Chancellor for Research.

Institutional Approval confirms that applicable requirements have been completed or designated as responsibilities of the study team to complete. These determinations will be formally documented in the approval notice:

• Contracts/agreements have been fully executed,
• Compliance requirements have been met,
• Regulatory approvals have been secured, and
• Financial/ administrative tasks have been completed.

Institutional Approval is separate from Institutional Review Board (IRB) approval and does not replace or modify any IRB requirements.

Permitted Pre-Institutional Approval Activities

• Assessing study feasibility,
• Completing study team training,
• Developing study tools and databases,
• Securing supplies and preparing study documentation,
• Completing site initiation visits, and/or
• Conducting participant pre-screening (only following IRB approval).

Compliance Responsibilities

Noncompliance with this policy may result in corrective or disciplinary action, including suspension of research activities, withdrawal of IRB approval, or, if warranted, termination of employment. In accordance with applicable laws and University policies, instances of noncompliance may also be reported to sponsors, regulatory agencies, or other oversight bodies.

The OVCR Office of Clinical Research Support and Operations, in coordination with other responsible offices, is responsible for monitoring compliance and addressing violations as appropriate.

Definitions

Clinical Research: For the purpose of this policy, the National Institutes of Health (NIH) definition of Clinical Research applies:

“Research with human subjects that is:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies; or:
2. Epidemiological and behavioral studies; or
3. Outcomes research and health services research."

Institutional Approval: Confirmation from the OVCR that the required elements for initiating a Clinical Research project, as outlined in this policy, have been completed.

Related Requirements

External Regulations

• 45 CFR Part 46 – Protection of Human Subjects
• 21 CFR Part 50 – Protection of Human Subjects (Informed Consent)
• 21 CFR Part 56 – Institutional Review Boards
• 21 CFR Part 312 – Investigational New Drug Application
• 21 CFR Part 812 – Investigational Device Exemptions
• 42 CFR Part 11 – Clinical Trials Registration and Results Information Submission

University Policies, Standards, and Procedures

• Managing Clinical Research Administrative Data Policy
• Managing Clinical Research Administrative Data Standard
• OHRE/IRB Policies and Procedures
• One UNC Clinical Research: Study Start-Up Playbook
• OSP Policies and Procedures
• Policy on Clinical Research Billing

Contact Information

Primary Contact

Name: Laura Viera

Title: Assistant Vice Chancellor for Clinical Research

Email: laura_viera@med.unc.edu