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. (1) identification of project and investigator;
2. (2) abstract, containing a short description;
3. (3) statement of objectives and rationale;
4. (4) description of methodology, including projected number of people and time involved;
5. (5) measures taken to protect subjects' interests, including, if necessary, informed consent;
6. (6) statement of interests of involved mental health programs; and
7. (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.