BILL ANALYSIS Ó
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair
2015 - 2016 Regular
Bill No: SB 1238 Hearing Date: April 19, 2016
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|Author: |Pan |
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|Version: |March 29, 2016 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant:|JRD |
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Subject: Inmates: Biomedical Data
HISTORY
Source: California Correctional Healthcare Services
Prior Legislation:None known
Support: Unknown
Opposition:None known
PURPOSE
The purpose of this bill is to permit records-based biomedical
research, using existing information, to be conducted on
prisoners, notwithstanding a prohibition on biomedical research
on prisoners.
Existing law defines:
"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
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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.
"Biomedical research" as research relating to or
involving biological, medical, or physical science.
"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.
"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.
"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.
"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.
(Penal Code § 3500.)
Existing law provides that the Legislature affirms the
fundamental right of competent adults to make decisions about
their participation in behavioral research. (Penal Code § 3501.)
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Existing law provides that biomedical research shall not be
conducted on any prisoner in this state. (Penal Code § 3502.)
Existing law provides that notwithstanding Section 3502, any
physician who provides medical care to prisoners may provide a
patient who is prisoner with a drug or 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. And, notwithstanding any other
provision of law, neither a public
entity nor a public employee shall be liable for any injury
caused by the administration of a drug pursuant, where the
administration is made as specified. (Penal Code § 3502.5.)
Existing law 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. (Penal Code § 3504.)
Existing law 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.
(Penal Code § 3505.)
Existing law 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. (Penal Code § 3508.)
This bill permits records-based biomedical research using
existing information, without prospective interaction with human
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subjects, to be conducted on prisoners, notwithstanding a
prohibition on biomedical research on prisoners.
This bill restricts the use or disclosure of individually
identifiable records pursuant to the above provision permitting
records-based biomedical research to only occurring after both
of the following requirements have been met:
The research advisory committee, established pursuant to
specified provisions of existing California regulations
pertaining to research involving prisoners (currently
limited to behavioral research), approves of the use or
disclosure; and,
The prisoner provides written authorization for the use
or disclosure, or the use or disclosure is permitted by
specified provisions of federal HIPAA regulations.
This bill 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
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the past several years this Committee has scrutinized
legislation referred to its jurisdiction for any potential
impact on prison overcrowding. Mindful of the United States
Supreme Court ruling and federal court orders relating to the
state's ability to provide a constitutional level of health care
to its inmate population and the related issue of prison
overcrowding, this Committee has applied its "ROCA" policy as a
content-neutral, provisional measure necessary to ensure that
the Legislature does not erode progress in reducing prison
overcrowding.
On February 10, 2014, the federal court ordered California to
reduce its in-state adult institution population to 137.5% of
design capacity by February 28, 2016, as follows:
143% of design bed capacity by June 30, 2014;
141.5% of design bed capacity by February 28, 2015; and,
137.5% of design bed capacity by February 28, 2016.
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In December of 2015 the administration reported that as "of
December 9, 2015, 112,510 inmates were housed in the State's 34
adult institutions, which amounts to 136.0% of design bed
capacity, and 5,264 inmates were housed in out-of-state
facilities. The current population is 1,212 inmates below the
final court-ordered population benchmark of 137.5% of design bed
capacity, and has been under that benchmark since February
2015." (Defendants' December 2015 Status Report in Response to
February 10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge
Court, Coleman v. Brown, Plata v. Brown (fn. omitted).) One
year ago, 115,826 inmates were housed in the State's 34 adult
institutions, which amounted to 140.0% of design bed capacity,
and 8,864 inmates were housed in out-of-state facilities.
(Defendants' December 2014 Status Report in Response to February
10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge Court, Coleman
v. Brown, Plata v. Brown (fn. omitted).)
While significant gains have been made in reducing the prison
population, the state must stabilize these advances and
demonstrate to the federal court that California has in place
the "durable solution" to prison overcrowding "consistently
demanded" by the court. (Opinion Re: Order Granting in Part and
Denying in Part Defendants' Request For Extension of December
31, 2013 Deadline, NO. 2:90-cv-0520 LKK DAD (PC), 3-Judge Court,
Coleman v. Brown, Plata v. Brown (2-10-14). The Committee's
consideration of bills that may impact the prison population
therefore will be informed by the following questions:
Whether a proposal erodes a measure which has contributed
to reducing the prison population;
Whether a proposal addresses a major area of public safety
or criminal activity for which there is no other
reasonable, appropriate remedy;
Whether a proposal addresses a crime which is directly
dangerous to the physical safety of others for which there
is no other reasonably appropriate sanction;
Whether a proposal corrects a constitutional problem or
legislative drafting error; and
Whether a proposal proposes penalties which are
proportionate, and cannot be achieved through any other
reasonably appropriate remedy.
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COMMENTS
1. Need for This Bill
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 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.
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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 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
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prison system has undertaken a massive program for
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 these health treatment programs.
Specifically, this bill excludes from the definition of
"biomedical research," and therefore exempts from the ban on
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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.
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