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 3500 of the Penal Code is amended to
2read:
For purposes of this title:
4(a) begin delete“Behaviorial end deletebegin insert“Behavioral end insertresearch” means studies involving,
5but not limited to, the investigation of human behavior, emotion,
6adaptation, conditioning, and response in a program designed to
7test certain hypotheses through the collection of objective data.
8Behavioral research does not include the accumulation of statistical
P2 1data in the assessment of the effectiveness of programs to which
2inmates are routinely assigned,begin delete such as,end deletebegin insert
including,end insert
but not limited
3to, education, vocational training, productive work, counseling,
4recognized therapies, and programsbegin delete whichend deletebegin insert thatend insert are not experimental
5in nature.
6(b) “Biomedical research” means research relating to or
7involving biological, medical, or physical science.begin insert Biomedical
8research does not include the accumulation of statistical data in
9the assessment of the effectiveness of nonexperimental public health
10programs or treatment programs in which inmates routinely
11participate.end insert
12(c) “Psychotropic drug” meansbegin delete anyend deletebegin insert
aend insert drug that has the capability
13of changing or controlling mental functioning or behavior through
14direct pharmacological action.begin delete Suchend deletebegin insert Theseend insert drugs include, but are
15not limited to, antipsychotic, antianxiety, sedative, antidepressant,
16and stimulant drugs. Psychotropic drugs also include mind-altering
17and behavior-altering drugsbegin delete which,end deletebegin insert that,end insert in specified dosages, are
18used to alleviate certain physical disorders, and drugsbegin delete whichend deletebegin insert thatend insert
19
are ordinarily used to alleviate certain physical disorders but may,
20in specified dosages, have mind-altering or behavior-altering
21effects.
22(d) “Research” means a class of activities designed to develop
23or contribute to generalizablebegin delete knowledge such asend deletebegin insert knowledge,
24includingend insert theories, principles, or relationships, or the accumulation
25of data on which they may be based, that can be corroborated by
26accepted scientific observation and inferences.
27(e) “Research protocol” means a formal document setting forth
28the explicit objectives of a research project and the procedures of
29investigation designed to reach those objectives.
30(f) “Phase I drug” meansbegin delete anyend deletebegin insert
aend insert drugbegin delete whichend deletebegin insert thatend insert is designated
31as a phase I drug for testing purposes under the federal Food and
32Drug Administration criteria inbegin delete Section 312.1end deletebegin insert Part 312 of
33Subchapter D of Chapter Iend insert of Title 21 of the Code of Federal
34Regulations.
Section 3502 of the Penal Code is amended to read:
begin insert(a)end insertbegin insert end insert Biomedical research shall not be conducted on any
37prisoner in this state.
P3 1(b) Notwithstanding subdivision (a), records-based biomedical
2research using existing information, without prospective interaction
3with human subjects, may be conducted consistent with this title.
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