The Clinical Research Compliance Office is pleased to announce the University of North Carolina at Chapel Hill Policy on Delegating Clinical Research Tasks in Research. This policy supports safe and compliant delegation of clinical tasks in human subjects research.
Purpose: The policy outlines the requirements for delegation of clinical tasks to personnel in the conduct of clinical research within the University of North Carolina at Chapel Hill. It ensures that anyone delegated a clinical task for clinical research purposes is appropriately licensed, qualified, and trained for their responsibilities.
Why It Matters: Delegating clinical tasks is a routine part of conducting research, but it also carries significant responsibility. This policy promotes participant safety, ensures compliance with federal and state regulations, and helps protect researchers and the University from unnecessary risk. Clear standards for delegation also support consistent practices across studies, making research at UNC-Chapel Hill both safer and more efficient.
Key Points:
- Applicability: This policy applies to all University faculty, staff members, postdoctoral appointees, students, trainees, consultants, and any other individuals engaged in clinical research.
- Requirements: Principal Investigators (PIs) may delegate clinical tasks only when the delegation is:
- Consistent with licensure laws, certification requirements, regulations, and other applicable legal obligations.
- Supported by requisite training.
- Documented in clinical research record.
- Subject to ongoing PI supervision of the delegated task, with the level and type of oversight determined by the nature of the delegated task and its potential impact on the participant safety.
- PI Responsibility: PIs must verify licensure, certification, and requisite training prior to delegating clinical tasks.
- Guidance: This policy includes Appendix A: Delegation Key for Clinical Tasks in Research, which provides guidance on which clinical tasks at UNC-Chapel Hill facilities require licensure and/or certification.
For more details, please refer to the full policy document or contact Jamie Kauwell, Interim Director, Clinical Research Compliance Office, at [email protected] or [email protected]