University Policy
Title
University of North Carolina at Chapel Hill Policy on Delegating Clinical Tasks in Research
Introduction
Purpose
This policy outlines the requirements for the delegation of Clinical Tasks to personnel in the conduct of Clinical Research within the University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") facilities. It ensures that individuals to whom Clinical Tasks are delegated for Clinical Research purposes are appropriately licensed, qualified, and trained for their specific responsibilities.
Scope
This policy applies to all Covered Individuals involved in Clinical Research conducted by the University at University facilities. Nothing in this policy is intended to limit or otherwise contradict any applicable laws or regulations.
Policy
Policy Statement
Covered Individuals must operate within their designated scope of practice as defined by the University. Engaging in research does not relieve personnel from any requirements to adhere to laws or regulations applicable to the performance of Clinical Tasks. If personnel are not qualified to perform a Clinical Task in standard clinical practice, they are not qualified to perform it for research purposes. Additionally, certain Clinical Tasks may require specific licensure or certification. Adherence to best practices in all areas related to the clinical task is strongly encouraged to ensure participant safety and uphold quality standards.
Delegation of Clinical Tasks is permissible by a Principal Investigator (PI) when it is:
- Consistent with licensure laws, certification requirements, regulations, and other applicable legal obligations;
- Accompanied by requisite training;
- Documented in the clinical research record; and
- Subject to ongoing supervision of the delegated task by the delegating Principal Investigator. The level and type of supervision is predicated on the nature of the delegated activities and risk to participant safety.
Principal Investigators are responsible for confirming appropriate licensure, certification, and requisite training prior to delegating Clinical Tasks.
Appendix A serves as a reference for common clinical research tasks at University facilities that require licensure and/or certification.
For questions, contact the Clinical Research Compliance Office (CRCO) at ClinResComp@unc.edu.
Definitions
Certification: A formal process by which a recognized professional organization, regulatory body, or educational institution verifies and attests that an individual has met specific qualifications—such as education, training, and demonstrated competence—required to safely and effectively perform designated clinical tasks within a defined scope of practice.
Clinical Research: Research with human subjects that is:
- 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.
- Epidemiological and behavioral studies.
- Outcomes research and health services research.
Studies falling under 45 CFR Part 46.101(b)(4) (the "Common Rule" prior to July 19, 2018) and 45 CFR Part 46.104(d)(4) (the "Revised Common Rule" effective July 19, 2018, Exemption 4) are not considered clinical research by this definition.
Clinical Task: A Clinical Task is any activity or procedure performed as part of patient care or clinical research that requires specific knowledge, skills, and training in healthcare. These tasks may include, but are not limited to, diagnostic procedures, administering treatments, monitoring patient conditions, or other activities directly related to patient health, often governed by regulatory, professional, or institutional guidelines.
Covered Individuals: University faculty, staff members, post-doctoral appointees, students, trainees, consultants, and any other individuals engaged in clinical research.
Licensure: Formal permission granted by a governmental or regulatory authority that allows an individual to legally perform specific clinical tasks within a defined scope of practice. It is based on meeting established educational, training, and competency standards and is typically required by law to ensure the safe and ethical delivery of clinical services.
Principal Investigator (PI): The primary individual responsible for overseeing the design, implementation, and management of a research study or clinical trial, and who holds overall accountability for ensuring proper supervision of those to whom Clinical Tasks are delegated.
University Facilities: All buildings, structures, open space and other real property, and other physical facilities, interior and exterior, owned or leased by the University. This includes facilities where research may take place, including, but not limited to:
- UNC Faculty Physician Clinics
- School of Medicine Clinical & Translational Research Center (CTRC)
- Eastowne Clinical Research Unit
- UNC Horizons Program
- TEACCH Autism Program
- UNC Psychology and Neuroscience Community Clinic
This list is not exhaustive. Questions about facility eligibility should be directed to the Office of the Vice Chancellor for Research – Clinical Research Operations.
Related Requirements
External Regulations
- N.C. Gen. Stat. § 90, Medicine and Allied Occupations
- 21 N.C. Admin. Code §§ 1, 3, 10, 16, 17, 30, 31, 32, 33, 36, 38, 40, 42, 46, 48, 52, 53, 54, 61, 64, 68
- N.C. Board of Nursing Position Statement - RN and LPN Practice Delegation and Assignment of Nursing Activities
- N.C. Board of Nursing Position Statement – Delegation of Medication Administration to UAP
- N.C. Board of Nursing Decision Tree for Delegation to UAP
- FDA Guidance Document: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
- FDA: E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), Guidance for Industry – 2.7, 2.8, 4.2.3, 4.3.1
University Policies, Standards, and Procedures
Contact Information
Primary Contact
Name: Jamie Kauwell, Interim Director
Unit: Clinical Research Compliance
Email: jamieb@email.unc.edu
Appendices
Appendix A: Delegation Key for Clinical Tasks in Research
Purpose: This key provides guidance on which clinical tasks at UNC-Chapel Hill facilities require licensure and/or certification. It supports informed decisions about task delegation while promoting high standards of safety, quality, and regulatory compliance. Please note that all clinical tasks require documented training and competency.
This key includes various Clinical Tasks performed in research but is not exhaustive. For any tasks not listed, please contact the Clinical Research Compliance Office (CRCO) at ClinResComp@unc.edu for assistance.
| Clinical Tasks Performed in Clinical Research 7 |
Licensure/Certification Required?
(Requirements compiled from: NC Board of Medicine, NC Board of Nursing, UNC Healthcare Policies)
|
| Basic Procedures |
| Vital Signs, Pulse Ox |
No 1 |
| Venipuncture |
No 1 |
| ECG - 12 lead |
No 1 |
| Basic Spirometry |
No 1 |
| Point of Care Testing |
No 1 |
| Allergy Skin Testing |
Yes: LPN 2, Certified Medical Assistant (CMA) |
| Advanced Procedures |
| Peripheral IV insertion |
Yes: RN 3 |
| Drawing blood from saline lock |
Yes: RN 3 |
| Blood draw from Port-a-cath or central Line |
Yes: RN 3 |
| Invasive procedures (urinary catheter insertion, Naso-gastro tube insertion) |
Yes: RN 3 |
| Physical Exams 5 |
Yes: RN 3 |
| Lumbar Puncture |
Yes: APP 4 |
| Medication Administration |
| Oral, subcutaneous (SQ), intramuscular (IM), intravenous (IV), inhalation, intradermal |
Yes: LPN 2 |
| IV push, chemotherapeutics, investigational meds, epidural |
Yes: RN 3 |
| Investigational Product Management |
| Providing investigational product exempt from IDS management to research participants 6 |
No |
| Accountability for medications (pill count, diary review, data collection) |
No |
1 Requires the PI to provide documented training and competency verification. (For additional information regarding the availability of training specifically for vital signs, ECG, and phlebotomy, please see Events).
2 A Licensed Practical Nurse (LPN) is the minimum qualification required; individuals with higher-level credentials—such as Registered Nurses (RNs), Advanced Practice Providers (APPs), as well as MDs and DOs—are also eligible to perform clinical procedures, provided they are within their licensed scope of practice.
3 A licensed Registered Nurse (RN) is the minimum qualification required; individuals with higher-level credentials—such as Advanced Practice Providers (APPs), as well as MDs and DOs—are also eligible to perform clinical procedures, provided they are within their licensed scope of practice.
4 An Advanced Practiced Provider (APP) is the minimum qualification required; individuals with higher-level credentials—such as MDs and DOs—are also eligible to perform clinical procedures, provided they are within their licensed scope of practice.
5 Review protocol for specific requirements.
6 Dispensing of investigational product not requiring UNC Healthcare Investigational Drug Services management follows University of North Carolina At Chapel Hill Policy: Principal Investigator Oversight and Management of Investigational Drugs.
7 Adherence to best practices in all areas related to the clinical task is strongly encouraged. Please contact the appropriate unit with questions.