Review of Research in Progress

PURPOSE: This rule prescribes the procedures by which the Professional Review Committee may review and investigate research. (1) The terms defined in section 630.005, RSMo are incorporated into this rule. As used in this administrative rule, the following terms mean: (A) Professional review committee (PRC) is the ten- (10-) person committee established under section 630.193, RSMo and appointed by the department director or designee to review and recommend approval or disapproval of proposed research projects; (B) Approved research is any behavioral or psychological research, biomedical research, pharmacological research, or program evaluation approved by the PRC; (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 (D) PRC coordinator is appointed by the department director or designee. (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. (A) The principal investigator shall provide a report of the results to the department upon completion of the project. (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) 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. (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. (B) The coordinator shall notify the principal investigator and all facility directors where the project is being conducted of any complaints received. (C) The principal investigator may respond in writing to any complaint regarding the project. (D) The facility director shall investigate the complaint and provide recommendations to the coordinator of the PRC within ten (10) days of the filing of the complaint. The facility director may chose to suspend or halt the project after receiving notification of a complaint. The facility director shall notify the principal investigator and the coordinator of any decision to suspend or halt a research project. (4) The PRC may investigate any research project which it has approved. The PRC shall investigate any approved research project when it has reason to believe that harm or increased risk of harm to the subjects or deviation from approved protocol has occurred. (A) The PRC may halt the research project while it is under investigation. (B) The principal investigator shall provide information requested by the PRC that is necessary for the investigation. (C) Employees of the department shall provide information requested by the PRC that is necessary for the investigation. (D) Staff of vendor agencies serving clients of the department shall provide information requested by the PRC necessary for the investigation. (E) The PRC shall rule on projects which have been investigated. 1. The PRC may take into account information received from the facility director where the project is conducted, from the principal investigator, and from other sources having information pertaining to the project. 2. The PRC may rule to halt the project or suspend the project until deficiencies are corrected. 3. The principal investigator and the facility director shall be notified of the decision of the PRC. (5) At the request of a facility director, the PRC may investigate research activities which have not been reviewed including archival studies and program evaluation projects. AUTHORITY: section 630.194, RSMo 2016.* Original rule filed Nov. 30, 1987, effective May 12, 1988. Rescinded: Filed Sept. 1, 1995, effective March 30, 1996. Readopted: Filed May 20, 1996, effective Dec. 30, 1996. Amended: Filed July 26, 2016, effective Feb. 28, 2017. *Original authority: 630.194, RSMo 1980.