BILL ANALYSIS
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THIRD READING
Bill No: SB 1187
Author: Strickland (R)
Amended: 4/29/10
Vote: 21
SENATE JUDICIARY COMMITTEE : 4-0, 4/27/10
AYES: Corbett, Hancock, Leno, Walters
NO VOTE RECORDED: Harman
SENATE HEALTH COMMITTEE : 9-0, 5/5/10
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox, Leno,
Negrete McLeod, Pavley, Romero
SUBJECT : Human experimentation
SOURCE : American College of Emergency Physicians,
California
Chapter
DIGEST : This bill extends, until January 1, 2014, an
existing exception to the Protection of Human Subjects in
Medical Experimentation Act, under which medical
experimental treatment may be provided to a patient without
the patient's informed consent in a life-threatening
situation, if prescribed conditions are met.
ANALYSIS :
Existing federal law:
CONTINUED
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1. Establishes general procedures and protections
pertaining to the use of human subjects in medical
experimentation, which includes obtaining informed
consent from a subject or a subject's legally authorized
representative. Unauthorized medical treatment is
punishable by both civil and criminal penalties.
2. Provides a narrow exception to the informed consent
requirements if both the investigator and a physician,
who is not otherwise participating in the clinical
investigation, certify in writing, that specified
conditions are met, which includes that a subject is
confronted by a life-threatening situation necessitating
the use of the experimental treatment.
Existing state law:
1. Provides protections for subjects of medical
experimentation and penalties for violations of those
provisions under the Protection of Human Subjects in
Medical Experimentation Act (Act). These protections
include:
A. A bill of rights for subjects of medical
experimentation, written in a language in which the
subject is fluent, and a requirement that the subject
receive a copy.
B. A requirement that the subject give a signed,
written, informed consent form for the procedures,
drugs, or devices that will be applied or taken.
C. A requirement that specified disclosures be
provided, including the right to withdraw consent;
affiliation and identification of persons conducting
the experiment; sponsor funding source or
manufacturer of the experiment; and a third party to
whom a subject may direct complaints.
D. A right to give consent freely and without force,
fraud, duress, or undue influence.
2. Establishes that the performance of a medical experiment
without a patient's informed consent is punishable by
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both civil and criminal penalties.
3. Provides an exception from the Act, until January 1,
2011, for any medical experimental treatment that
benefits a patient who is subject to a life-threatening
emergency, if prescribed conditions are met. These
conditions include the following:
A. Care must be provided in accordance with the
procedures and the additional protections of the
rights and welfare of the patient required by federal
regulations.
B. The patient is in a life-threatening situation,
necessitating urgent intervention, and available
treatments are unproven or unsatisfactory.
C. The patient is unable to give informed consent as
a result of the patient's medical condition.
D. Obtaining informed consent from the patient's
legally authorized representatives is not feasible
before the treatment must be administered.
E. There is no reasonable way to identify
prospectively the individuals likely to become
eligible for participation in the clinical
investigation.
F. Valid scientific studies have been conducted that
support the potential for intervention to provide a
direct benefit to the patient.
This bill extends the exception under which medical
experimental treatment may be provided to a patient without
the patient's informed consent in a life-threatening
situation, if prescribed conditions are met, until January
1, 2014.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No
Local: No
SUPPORT : (Verified 5/6/10)
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American College of Emergency Physicians, California
Chapter (source)
California Hospital Association
Emergency Nurses Association
Los Angeles Biomedical Research Institute, Harbor UCLA
Medical Center
University of California
ARGUMENTS IN SUPPORT : The author's office states that
researchers in emergency medicine and other specialties are
trying to discover better treatments for critically ill
patients, including those needing resuscitation due to
trauma or cardiac arrest. According to the author's
office, this bill is needed to ensure that critical,
life-saving research can continue in California, which will
lead to saving lives and providing better emergency care
for numerous patients.
The American College of Emergency Physicians, California
Chapter (CAL/ACEP), the bill's sponsor, argues that in an
effort to allow clinical research in emergency settings
when informed consent is not feasible, the federal
government created stringent guidelines to allow for these
types of clinical trials. CAL/ACEP contends that this bill
is needed to continue to allow life-saving research in
life-threatening situations to take place in California.
Los Angeles Biomedical Research Institute (LA BioMed) adds
that California law is generally more restrictive than
federal law, and may block life-saving research, without
the exception that would be extended by this bill. LA
BioMed argues that the incompatibility between state and
federal law is why the exception to the Act was put into
place years ago.
The University of California (UC) states that it operates
medical centers in Davis, Los Angeles, Irvine, San Diego,
and San Francisco and that the UC clinical enterprise is
the fourth largest health care delivery system in the
state. UC further states that it is one of the largest
recipients of NIH funding in the nation for cutting-edge
research. UC contends that providing complex critical care
to California's medically vulnerable population, and
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undertaking medical research are two of its key missions,
and this bill will enable it to continue these missions.
The California Hospital Association states that without
this bill, patients who are unable to give informed consent
due to a medical condition will be precluded from receiving
what might be life-saving treatment because it is
experimental.
RJG:mw 5/6/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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