Amended in Senate March 29, 2016

Senate BillNo. 1238


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 amended, 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:

P1    1

SECTION 1.  

Section 3500 of the Penal Code is amended to
2read:

3

3500.  

For purposes of this title:

4(a) “Behavioral research” means studies involving, but not
5limited to, the investigation of human behavior, emotion,
6adaptation, conditioning, and response in a program designed to
P2    1test certain hypotheses through the collection of objective data.
2Behavioral research does not include the accumulation of statistical
3data in the assessment of the effectiveness of programs to which
4inmates are routinely assigned, including, but not limited to,
5education, vocational training, productive work, counseling,
6recognized therapies, and programs that are not experimental in
7nature.

8(b) “Biomedical research” means research relating to or
9involving biological, medical, or physical science. Biomedical
10research does not include the accumulation of statistical data in
11the assessment of the effectiveness of nonexperimental public
12health programs or treatment programs in which inmates routinely
13participate.

14(c) “Psychotropic drug” means a drug that has the capability of
15changing or controlling mental functioning or behavior through
16direct pharmacological action. These drugs include, but are not
17limited to, antipsychotic, antianxiety, sedative, antidepressant, and
18stimulant drugs. Psychotropic drugs also include mind-altering
19and behavior-altering drugs that, in specified dosages, are used to
20alleviate certain physical disorders, and drugs that are ordinarily
21used to alleviate certain physical disorders but may, in specified
22dosages, have mind-altering or behavior-altering effects.

23(d) “Research” means a class of activities designed to develop
24or contribute to generalizable knowledge, including theories,
25principles, or relationships, or the accumulation of data on which
26they may be based, that can be corroborated by accepted scientific
27observation and inferences.

28(e) “Research protocol” means a formal document setting forth
29the explicit objectives of a research project and the procedures of
30investigation designed to reach those objectives.

31(f) “Phase I drug” means a drug that is designated as a phase I
32drug for testing purposes under the federal Food and Drug
33Administration criteria in Part 312 of Subchapter D of Chapter I
34of Title 21 of the Code of Federal Regulations.

35

SEC. 2.  

Section 3502 of the Penal Code is amended to read:

36

3502.  

(a) Biomedical research shall not be conducted on any
37prisoner in this state.

38(b) Notwithstanding subdivision (a), records-based biomedical
39research using existing information, without prospective interaction
40with human subjects, may be conducted consistent with this title.
P3    1
begin insert The use or disclosure of individually identifiable records pursuant
2to this subdivision shall only occur after both of the following
3requirements have been met:end insert

begin insert

4
(1) The research advisory committee established pursuant to
5Section 3369.5 of Title 15 of the California Code of Regulations
6approves of the use or disclosure.

end insert
begin insert

7
(2) The prisoner provides written authorization for the use or
8disclosure, or the use or disclosure is permitted by Section 164.512
9of Title 45 of the Code of Federal Regulations.

end insert


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