BILL ANALYSIS Ó
SB 1238
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Date of Hearing: June 28, 2016
Counsel: Gabriel Caswell
ASSEMBLY COMMITTEE ON PUBLIC SAFETY
Reginald Byron Jones-Sawyer, Sr., Chair
SB
1238 (Pan) - As Amended March 29, 2016
SUMMARY: Permits records-based, statistical research, using
existing information, to be conducted on prisoners,
notwithstanding a prohibition on biomedical research on
prisoners. Specifically, this bill:
1)Permits records-based biomedical research using existing
information, without prospective interaction with human
subjects, to be conducted on prisoners, notwithstanding a
prohibition on biomedical research on prisoners.
2)Restricts the use or disclosure of individually identifiable
records pursuant to the above provision permitting
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records-based biomedical research to only occurring after both
of the following requirements have been met:
a) The research advisory committee, established pursuant to
specified provisions of existing California regulations on
research involving prisoners (currently limited to
behavioral research), approves of the use or disclosure;
and,
b) The prisoner provides written authorization for the use
or disclosure, or the use or disclosure is permitted by
specified provisions of federal HIPAA regulations.
3)Excludes from the definition of "biomedical research," for
purposes of provisions of law governing biomedical and
behavioral research of prisoners, the accumulation of
statistical data in the assessment of the effectiveness of
nonexperimental public health programs or treatment programs
in which inmates routinely participate
EXISTING LAW:
1)Defines the following terms: (Pen. Code, § 3500.)
a) "Behavioral research" as 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, but not limited to, education,
vocational training, productive work, counseling,
recognized therapies, and programs which are not
experimental in nature.
b) "Biomedical research" as research relating to or
involving biological, medical, or physical science.
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c) "Psychotropic drug" as any drug that has the capability
of changing or controlling mental functioning or behavior
through direct pharmacological action. Such drugs include,
but are not limited to, antipsychotic, antianxiety,
sedative, antidepressant, and stimulant drugs. Psychotropic
drugs also include mind-altering and behavior-altering
drugs which, in specified dosages, are used to alleviate
certain physical disorders, and drugs which are ordinarily
used to alleviate certain physical disorders but may, in
specified dosages, have mind-altering or behavior-altering
effects.
d) "Research" as a class of activities designed to develop
or contribute to generalizable knowledge such as 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" as 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" as any drug which is designated as a
phase I drug for testing purposes under the federal Food
and Drug Administration criteria in Section 312.1 of Title
21 of the Code of Federal Regulations.
2)Provides that the Legislature affirms the fundamental right of
competent adults to make decisions about their participation
in behavioral research. (Pen. Code, § 3501.)
3)Provides that biomedical research shall not be conducted on
any prisoner in this state. (Pen. Code, § 3502.)
4)Provides that notwithstanding the bar of biomedical research
on prisoners, any physician who provides medical care to
prisoners may provide a patient who is prisoner with a drug or
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treatment available only through a treatment protocol or
treatment IND (investigational new drug) if the physician
determines that access to that drug is in the best medical
interest of the patient, and the patient has given informed
consent. (Pen. Code, § 3502.5.)
5)States that any physical or mental injury of a prisoner
resulting from the participation in behavioral research,
irrespective of causation of such injury, shall be treated
promptly and on a continuing basis until the injury is cured.
(Pen. Code, § 3504.)
6)Requires that behavioral research be limited to studies of the
possible causes, effects and processes of incarceration and
studies of prisons as institutional structures or of prisoners
as incarcerated persons which present minimal or no risk and
no more than mere inconvenience to the subjects of the
research. Informed consent shall not be required for
participation in behavioral research when the department
determines that it would be unnecessary or significantly
inhibit the conduct of such research. In the absence of such
determination, informed consent shall be required for
participation in behavioral research. (Pen. Code, § 3505.)
7)Requires that behavioral-modification techniques shall be used
only if such techniques are medically and socially acceptable
means by which to modify behavior and if such techniques do
not inflict permanent physical or psychological injury. (Pen.
Code, § 3508.)
FISCAL EFFECT:
COMMENTS:
1)Author's Statement: According to the author, "Ten years ago,
federal court placed the state's prison health care system
under a receivership after determining that an average of one
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inmate per week died as a result of medical malpractice or
neglect. The receivership has improved healthcare in prisons
over the last ten years, but the inability to share
data-backed best practices contributes to the challenge of
providing quality health care to 127,000 inmates-who are
disproportionately Black and Latino. SB 1238 would authorize
the publication of statistical data in the assessment of the
effectiveness of nonexperimental public health programs or
treatment programs in which inmates routinely participate.
This would enable health care providers in prisons and jails
to learn from the best practices used at state correctional
facilities, and utilize these life-saving techniques.
"In August of 2015, microscopic bacteria contaminated the
water supply of San Quentin State Prison (SQ). A physician
working in the prison noticed an unusual number of
inmate-patients with pneumonia. Two hours into a collaborative
email chain, the healthcare providers of SQ identified the
cause of the pneumonia increase: Legionnaires' disease. Data
sharing among the heath care staff enabled the California
Correctional Health Care Services (CCHCS) and the California
Department of Corrections and Rehabilitation to respond to the
potential health crisis immediately. The quick identification
and effective treatment of the disease prevented the crisis
from turning fatal. Data sharing enabled this life-saving
response. The ability to publish some of this data would
allow other health care agencies to learn to better manage
similar health crises. Nonexperimental medical data can be
used to save lives while completely avoiding the ethical
dilemmas of allowing experimental biomedical research in
prisons.
"California's prison system has been on the cutting edge of
providing health care to prison inmates, but current law
prevents the publishing of non-experimental medical data that
could be used to improve health care in correctional
facilities and potentially save lives. Prisons face unique
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health care challenges, and SB 1238 would allow health care
providers to share and learn from non-experimental data in
order to provide higher quality health care."
2)California Department of Corrections Healthcare: Federal
Receivership: CCHCS (federal receivership) was established as
a result of a class action lawsuit (Plata v. Brown) brought
against the State of California over the quality of medical
care in the state's 34 adult prisons. In its ruling, the
federal court found that the care was in violation of the
Eighth Amendment of the U.S. Constitution which prohibits
cruel and unusual punishment. The state settled the lawsuit
and entered into a stipulated settlement in 2002, agreeing to
a range of remedies that would bring prison medical care in
line with constitutional standards. The state failed to comply
with the stipulated settlement and on February 14, 2006, the
federal court appointed a receiver to manage medical care
operations in the prison system. The current receiver was
appointed in January of 2008. The receivership continues to be
unprecedented in size and scope nationwide.
CCHCS is the sponsor of this legislation and states in
support:
Over the last several years, the prison system has
been the site of extremely newsworthy medical
developments, and has been on the cutting edge of
providing treatment to prison inmates that would be
beneficial to share with the medical community at
large. Between 2012 and 2014, the prison system
experienced hunger strikes that lasted for a
significant period of time. As a result, prison
doctors developed an effective monitoring system that
provided appropriate treatment as needed during the
strikes. Additionally, for the past several years, the
prison system has undertaken a massive program for
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identifying and treating Valley Fever in our central
valley prisons: California was the first health care
system in the nation to use a newly developed skin
test that identifies exposure/non-exposure to Valley
Fever which is now used in making wise housing choices
for inmates statewide. Finally, just recently the
prison system had an outbreak of Legionnaires Disease
at San Quentin (SQ) State Prison where, due to quick
identification and effective treatment, doctors were
able to successfully treat inmates at SQ without the
loss of life.
California Correctional Health Care Services, which
oversees prison medical care, would like to publish
our findings in medical journals that would be of
benefit to other correctional and community entities.
However, under current law (added in the 1970s) there
currently is a prohibition in the California Penal
Code for performing or undertaking biomedical research
on prisoners Unfortunately, the broad nature of the
current statute would even prohibit CCHCS from
publishing an accumulation of statistical data that
provided an assessment of the effectiveness of any
non-experimental public health or treatment program
such as described above.
This bill would narrowly amend the Penal Code to allow
CCHCS to publish findings from non-experimental public
health or treatment programs.
3)Effect of This Legislation: This bill provides for the use of
statistical data from health treatment programs within prisons
in order to publish studies or reports on the efficacy of
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these health treatment programs. Specifically, this bill
excludes from the definition of "biomedical research," and
therefore exempts from the ban on this research, the
"accumulation of statistical data" in the assessment of
treatment programs in which inmates routinely participated.
This bill, additionally, authorizes biomedical research, but
only when it is records-based, using existing information, and
does not include prospective interaction with prisoners. In
this provision, the use or disclosure of individually
identifiable records is permitted, either with the written
authorization of the prisoner, or when the use or disclosure
is otherwise permitted under specified federal privacy
regulations that permit disclosure without written
authorization under certain circumstances.
REGISTERED SUPPORT / OPPOSITION:
Support
California Correctional Health Care Services (CCHCS)
Opposition
None
Analysis Prepared by:Gabriel Caswell / PUB. S. / (916)
SB 1238
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319-3744