Research

PURPOSE: This rule establishes standards and procedures for conducting research in Opioid Treatment Programs, Substance Use Disorder Treatment Programs, Comprehensive Substance Treatment and Rehabilitation Programs (CSTAR), Gambling Disorder Treatment Programs, Recovery Support Programs, Substance Awareness Traffic Offender Programs (SATOP), Required Education Assessment and Community Treatment Programs (REACT), Community Psychiatric Rehabilitation Programs (CPRP), and Outpatient Mental Health Treatment Programs. (1) General Policy. The organization shall have a written policy regarding research activities involving individuals served. The organization may prohibit research activities. (2) Policies and Practices in Conducting Research. If research is conducted, the organization shall assure that— (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. (B) Participating individuals are not the subject of experimental research without their prior written and informed consent or that of their guardian. (C) Participating individuals understand they may decide not to participate or may withdraw from any research at any time for any reason. (3) Notice to the Department. If any participating individual is receiving services funded by the department, the organization shall assure the research has the prior approval of the department and 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 2016.* Original rule filed Feb. 28, 2001, effective Oct. 30, 2001. Amended: Filed Nov. 5, 2018, effective June 30, 2019. *Original authority: 630.050, RSMo 1980, amended 1993, 1995, 2008 and 630.055, RSMo 1980.