Who are the key personnel?

Participating in nursing research:

Key Personnel are individuals who have access to Protected Health Information (PHI) and generate data either through direct interactions with subjects or through access to their medical records. Key Personnel and their study roles must be listed on an IRB submission.

In accordance with Duke IRB policy, individuals who are not Key Personnel are individuals who will be interacting with research subjects during the course of a research study, but only in his/her regular non-research employment capacities, such as a clinic receptionist, nurse, or phlebotomist, or a radiologist or radiology technician. These individuals should not be listed as Key Personnel for the study if the person will perform only genuinely non-collaborative services meriting neither professional recognition nor publication privileges, and not associated with individual financial gain, and will not contribute to the design, governance, and/or analysis of the study.

All Key Personnel must complete Duke Health Biomedical Research CITI (ethics) training.

Assure Key Personnel Qualifications