California Code, Penal Code - PEN § 3500




For purposes of this title:

(a) “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, including, but not limited to, education, vocational training, productive work, counseling, recognized therapies, and programs that 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” means a drug that has the capability of changing or controlling mental functioning or behavior through direct pharmacological action.  These drugs include, but are not limited to, antipsychotic, antianxiety, sedative, antidepressant, and stimulant drugs.  Psychotropic drugs also include mind-altering and behavior-altering drugs that, in specified dosages, are used to alleviate certain physical disorders, and drugs that 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 generalizable knowledge, 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” means a drug that is designated as a phase I drug for testing purposes under the federal Food and Drug Administration criteria in Part 312 of Subchapter D of Chapter I of Title 21 of the Code of Federal Regulations.





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