PURPOSE: This rule prescribes the procedures by which the Professional Review Committee may review and investigate research.

1. (1) The terms defined in section 630.005, RSMo are incorporated into this rule. As used in this administrative rule, the following terms mean:

   1. (A) Professional review committee (PRC) is the ten (10)-person committee established under section 630.192, RSMo and appointed by the director to review and recommend approval or disapproval of proposed research projects;
   2. (B) Approved research is any behavioral or psychological research, biomedical research, pharmacological research or program evaluation approved by the PRC;
   3. (C) Facility director is the chief administrator or director of a state facility, vendor facility or vendor agency which serves clients of the Department of Mental Health; and
   4. (D) PRC coordinator is the director of Research and Evaluation or other designee of the department director.

2. (2) Research which has been approved by the PRC shall be reviewed at one hundred eighty (180)-day intervals or more often as determined by the PRC from the date of approval until the project is completed. The principal investigator shall submit information as specified by the PRC regarding the status of the research project.

   1. (A) The principal investigator shall provide a report of the results to the department upon completion of the project.
   2. (B) Based on the information obtained in a review, the PRC shall investigate the project if any harm, increased risk of harm or unapproved deviation from the research protocol occurs.

3. (3) Any written complaint regarding research which produced harm, increased risk of harm or which failed to conform to approved research protocol shall be investigated by the PRC.

   1. (A) A complaint may be filed with a member of the PRC or its coordinator, or with a facility director where research is being conducted. Those receiving complaints shall provide a copy of the complaint to the coordinator.
   2. (B) The coordinator shall notify the principal investigator and all facility directors where the project is being conducted of any complaints received. 9 CSR 60-1
   3. (C) The principal investigator may respond 9 CSR 60-1.020 Archival and Program in writing to any complaint regarding the pro- Evaluation Activities ject. (Rescinded March 30, 1996)
   4. (D) The facility director shall investigate the complaint and provide recommendations