PURPOSE: This rule establishes standards and procedures for conducting research in Alcohol and Drug Abuse Programs, Comprehensive Substance Treatment and Rehabilitation Programs (CSTAR), Compulsive Gambling Treatment Programs, Substance Abuse Traffic Offender Programs (SATOP), Required Education Assessment and Community Treatment Programs (REACT), Community Psychiatric Rehabilitation Programs (CPRP), and Psychiatric Outpatient Programs.

1. (1) General Policy. The organization shall have a written policy regarding research activities involving individuals served. The organization may prohibit research activities.

2. (2) Policies and Practices in Conducting Research. If research is conducted, the organization shall assure that—

   1. (A) Compliance is maintained with all federal, state and local laws and regulations concerning the conduct of research including, but not limited to, sections 630.192, 630.199, 630.194, and 630.115, RSMo, 9 CSR 60-1.010 and 9 CSR 60-1.015;
   2. (B) Participating individuals are not the subject of experimental research without their prior written and informed consent or that of their parents or guardian, if minors;
   3. (C) Participating individuals understand that they may decide not to participate or may withdraw from any research at any time for any reason.
3. (3) Notice to the Department. If any participating individual is receiving services funded by the department or provided through a service network authorized by the department, the organization shall assure that the research has the prior approval of the department. The organization shall immediately inform the department of any adverse outcome experienced by an individual served due to participation in a research project.

AUTHORITY: sections 630.050 and 630.055, RSMo 2000.* Original rule filed Feb. 28, 2001, effective Oct. 30, 2001. *Original authority: 630.050, RSMo 1980, amended 1993, 1995 and 630.055, RSMo 1980.