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) Deputy director is the deputy director of the Office of Departmental Affairs;
   5. (E) 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;
   6. (F) Pharmacological research is experimentation with patients, clients or residents to determine responses to drugs or other substances;
   7. (G) 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
   8. (H) Research is experimentation or intervention with or on departmental patients, clients or residents, including behavioral or 9 CSR 60-1

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.

1. (2) Any person may request to do research on departmental clients by requesting the application for research with clients from the Office of Departmental Affairs (DMH form 8114). It is incumbent on the individual wishing to conduct research to seek and gain approval for research before initiating the project.
2. (3) The person requesting to do research shall send an application and ten (10) copies to the deputy director or designee. Based on the completed application, the deputy 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.
3. (4) For approved projects, it is incumbent on the principal investigator to ensure that execution of the project does not violate statutes.
4. (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 to 630.198, RSMo (1994).* Original rule filed March 18, 1987, effective Aug. 15, 1987. Amended: Filed July 17, 1995, effective March 30, 1996.

*Original authority 1980. STATE OF MISSOURI DEPARTMENT OF MENTAL HEALTH APPLICATION FOR RESEARCH WITH CLIENTS OF THE MISSOURI DEPARTMENT OF MENTAL HEALTH Title of Proposal I. Dates of Proposed Project Period _ Ii. Facility or Location where Research Project will be conducted Who will serve to oversee the project at the facility where the applicant works in a managerial member in a managerial position should be enlisted does not unnecessarily disrupt the unit’s operation. Facility Overseer Position Title I V. Who will serve as the principal investigator Research Guidelines of scientifically as per this definition, a more senior a student’s professor serves as the principal Attach curriculwn vitae OF applicant and principal I ‘rincipal Investigator Title 1. the research will be conducted? Unless capacity in the unit where the project will be conducted, a staff to ensure that the project proceeds smoothly and for the project? Note the definition in Standard 3.1 of the qualified individuals. If the applicant does not feel he/she qualifies researcher should be enlisted to oversee the project. Generally, investigator when the project receives academic credit. investigator. - Affiliation (11/30/g@ Rebecca McDowell Cook CODE OF STATE REGULATtONS Chapter l-Rules for Conducting Research and Program Evaluation V. If the proposed project which are known. 0 Master’s Thesis c] Doctoral Dissertation 0 Pilot study for thesis or dissertation 0 Other academic Indicate Indicate Has the project If yes, please attach a statement If no, please Vi. Please answer 1. Describe and assess the potential benefits review). Describe 2. Describe 3. Subjects: Briefly describe i.e., age, sex, ethnic background, Explain why a DMH client sample ethods: Discuss aims of the project. Describe tnclude or materials 5. Performance Sites: on the operation letter(s) VII. Human Subject Assurance Procedures: Describe consent will be solicited and obtained, and the method of documenting to use. / . Rebecca McDowell Cook is to serve as a requirement ._._ .-.-_.- requirement, please specify the University and Department the faculty member who will serve as your academic advisor received approval by your professor/committee? indicate expected date of approval the following questions the benefits to participants the relationship to other studies of this type. Include the potential in detail the research design and the procedures the means by which the data will be analyzed and interpreted. Point out any procedures, that may be hazardous Indicate where of the facility(ies), from the facility director(s) for an academic program, - Deadline for research. in which you are enrolled to that effect, signed by your professor. in a total of no more than seven pages. that may come as a result of the planned work (include and to mental health in general. literature subjects. Describe the characteristics diagnosis. Include target number of subjects and sampling is requested. the protocols to be used and the tentative to personnel and the precautions the project will be conducted. any assistance you will need reflecting tentative approval of the project. the procedure you intend the nature of information to be provided consent. Attach a copy of the letter of informed consent which you intend indicate its role. Include any deadlines 0 YES reviews to support your discussion. of the subject population, to be used to accomplish sequence of the investigation. to be exercised. Include the potential cost and impact from facility personnel, to follow to assure that info:med to prospective 9 CSR 60-l 0 NO literature techniques. the specific situations, etc. Enclose subjects, VIII. Funding Source: Briefly explain the funding source and the assurance throughout the project. Indicate who will be responsible of the project. :OMPLETE ONLY IF FUNDING IS REQUIRED IN ORDER TO COUPLETE THIS PROJECT. UPPLES ,rrEMlZE FJY CATEGORY) NSTATE IUTSTATE PLEASE SUBMIT ORlGtNAL AND TEN COPIES TO: you have that funds will be available for the incidental costs (Xerox, mail, transportation) Office of Departmental Affairs Research 8 Evaluation Section Department of Mental Health Post Office Box 687 Jefferson City, MO 65102 CODE OF STATE REGULA-DONS (11130196) Rebecca McDowell Cook