1. (a) Research that involves a client shall be reviewed and approved by a research review board established by the Department.
2. (b) The research review board shall approve, require modification, or disapprove proposed research projects subject to the approval of the Department.
3. (c) Individuals who are not directly associated with research projects under consideration shall comprise a majority of the review board.

4. (d) Each proposed research project shall be presented to a research review board as a written protocol containing the following information:

   1. (1) identification of the project and the investigator;
   2. (2) abstract, containing a short description of the project;
   3. (3) statement of objectives and rationale; and
   4. (4) description of methodology, including informed consent if necessary.

5. (e) Prior to the initiation of each research project, a research review board shall:

   1. (1) conduct an initial review of the project;
   2. (2) state the frequency with which it will review the project after it has been initiated; and
   3. (3) hold a review prior to any major changes being made in research procedures.

6. (f) Written minutes of each research board's meeting shall be maintained and contain documentation that:

   1. (1) risks to the client were minimal and reasonable for the benefits to be accrued;
   2. (2) client participation was voluntary;
   3. (3) unnecessary intrusion on the client was eliminated;
   4. (4) informed consent was obtained; and
   5. (5) compliance with confidentiality requirements as contained in Rule .0704 of these Rules.

History Note: Authority G.S. 148‑19(d);
Eff. January 4, 1994;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 20, 2015.