BILL NUMBER: SB 1238INTRODUCED BILL TEXT INTRODUCED BY Senator Pan FEBRUARY 18, 2016 An act to amend Sections 3500 and 3502 of the Penal Code, relating to prisons. LEGISLATIVE COUNSEL'S DIGEST SB 1238, as introduced, Pan. Inmates: biomedical data. Existing law prohibits biomedical research, as defined, from being conducted on any prisoner in the state. This bill would specify that biomedical research does not include the accumulation of statistical data in the assessment of the effectiveness of nonexperimental public health programs or treatment programs in which inmates routinely participate. The bill would authorize records-based biomedical research involving inmates that uses existing information, but which does not include prospective interaction with human subjects. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 3500 of the Penal Code is amended to read: 3500. For purposes of this title: (a)"Behaviorial"Behavioral research" means studies involving, but not limited to, the investigation of human behavior, emotion, adaptation, conditioning, and response in a program designed to test certain hypotheses through the collection of objective data. Behavioral research does not include the accumulation of statistical data in the assessment of the effectiveness of programs to which inmates are routinely assigned,such as,including, but not limited to, education, vocational training, productive work, counseling, recognized therapies, and programswhichthat are not experimental in nature. (b) "Biomedical research" means research relating to or involving biological, medical, or physical science. Biomedical research does not include the accumulation of statistical data in the assessment of the effectiveness of nonexperimental public health programs or treatment programs in which inmates routinely participate. (c) "Psychotropic drug" meansanya drug that has the capability of changing or controlling mental functioning or behavior through direct pharmacological action.SuchThese drugs include, but are not limited to, antipsychotic, antianxiety, sedative, antidepressant, and stimulant drugs. Psychotropic drugs also include mind-altering and behavior-altering drugswhich,that, in specified dosages, are used to alleviate certain physical disorders, and drugswhichthat are ordinarily used to alleviate certain physical disorders but may, in specified dosages, have mind-altering or behavior-altering effects. (d) "Research" means a class of activities designed to develop or contribute to generalizableknowledge such asknowledge, including theories, principles, or relationships, or the accumulation of data on which they may be based, that can be corroborated by accepted scientific observation and inferences. (e) "Research protocol" means a formal document setting forth the explicit objectives of a research project and the procedures of investigation designed to reach those objectives. (f) "Phase I drug" meansanya drugwhichthat is designated as a phase I drug for testing purposes under the federal Food and Drug Administration criteria inSection 312.1Part 312 of Subchapter D of Chapter I of Title 21 of the Code of Federal Regulations. SEC. 2. Section 3502 of the Penal Code is amended to read: 3502. (a) Biomedical research shall not be conducted on any prisoner in this state. (b) Notwithstanding subdivision (a), records-based biomedical research using existing information, without prospective interaction with human subjects, may be conducted consistent with this title.