PURPOSE: This rule prescribes procedures by which applications for research involving any client or patient or any individual identified by virtue of being a former client or patient of the department are submitted and reviewed for approval.

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

   1. (A) Archival research is the review or analysis of historical data generated by the department and kept as part of the permanent management information record;
   2. (B) Behavioral or psychological research is the experimentation with patients, clients, or residents to determine the effects of manipulation or application of environmental variables including, but not limited to, experimental use of behavior modification;
   3. (C) Biomedical research is experimentation by intruding into a patient’s, client’s, or resident’s body to monitor the biological reaction to controlled stimuli or biological study involving experimental medical or surgical procedures, withdrawal or removal of body tissues or fluids, or input of energy or manipulation of bodily processes;
   4. (D) 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;
   5. (E) Pharmacological research is experimentation with patients, clients, or residents to determine responses to drugs or other substances;
   6. (F) Program evaluation is an activity designed to assess or evaluate policies, procedures, or programs currently in operation to determine their effectiveness or usefulness or to identify needed changes, including survey research and specifically limited to instances where no manipulation of variables or conditions is involved; and
   7. (G) Research is experimentation or intervention with or on departmental patients, clients, or residents, including behavioral or psychological research, biomedical research, pharmacological research, and program evaluation. Excluded are those instances where the manipulation or application is intended solely and explicitly for individual treatment of a condition, falls within the prerogative of accepted practice, and is subject to appropriate quality assurance review. Also excluded are activities limited to program evaluation conducted by staff members as a regular part of their jobs, the collection or analysis of management information system data, archival research, or the use of departmental statistics.
2. (2) Any person may request to do research on departmental clients by requesting the application for research with clients from the department director or designee. It is incumbent on the individual wishing to conduct research to seek and gain approval for research before initiating the project.
3. (3) The person requesting to do research shall send an application to the department director or designee as indicated on the application. Based on the completed application, the department director or designee may exempt from PRC review those projects which do not meet the criteria of research as defined in section (1). In the case of projects approved by the facility director which are exempted from review, the facility director accepts the responsibility of insuring client confidentiality, informed consent, and the right to refuse to participate.
4. (4) For approved projects, it is incumbent on the principal investigator to ensure that execution of the project does not violate statutes.
5. (5) Statements provided in this regulation shall not be construed to limit client rights established by statutes, including the right to informed consent and the right to refuse to participate.

AUTHORITY: sections 630.192, 630.193 to 630.198, RSMo 2016.* Original rule filed March 18, 1987, effective Aug. 15, 1987. Amended: Filed July 17, 1995, effective March 30, 1996. Amended: Filed July 26, 2016, effective Feb. 28, 2017.

*Original authority: 630.192, RSMo 1980, amended 1996, 2011 and 630.193 to 630.198, RSMo 1980. See Missouri Revised Statutes, 2016.