The policy discusses state of North Carolina law terms and principles applicable to human subjects research, including:  legally authorized representative, child, and guardian.

The policy describes mandatory State of North Carolina reporting requirements.  A physician or other health professional must report certain conditions/circumstances/diseases to State and local agencies whether they are found in the course of non-research clinical care or as part of a research protocol. This policy relates to research-related findings that present themselves during the conduct of a protocol and must be reported outside of the institution.