10a NCAC 26c .0202      PROTOCOL

Before any investigation is launched involving the Division's clients, their records, or a mental health program's records, a written protocol of the planned study shall be submitted to the chief executive offices of the institution or area program. The protocol shall contain the following:

(1)           identification of project and investigator;

(2)           abstract, containing a short description;

(3)           statement of objectives and rationale;

(4)           description of methodology, including projected number of people and time involved;

(5)           measures taken to protect subjects' interests, including, if necessary, informed consent;

(6)           statement of interests of involved mental health programs; and

(7)           plans for dissemination and disposition of findings.

History Note:        Authority G.S. 143B‑147;

Eff. February 1, 1976;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. May 1, 2018.