North Carolina Administrative Code
Title 10A - HEALTH AND HUMAN SERVICES
Chapter 26 - MENTAL HEALTH, GENERAL
Subchapter C - OTHER GENERAL RULES
Section .0200 - RESEARCH
Section 26C .0202 - PROTOCOL
Current through Register Vol. 39, No. 6, September 16, 2024
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.
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.