BILL ANALYSIS
SB 1187
Page 1
Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON JUDICIARY
Mike Feuer, Chair
SB 1187 (Strickland) - As Amended: April 29, 2010
Proposed Consent
SENATE VOTE : 33-0
SUBJECT : Human Experimentation
KEY ISSUE : Should the sunset be extended on the existing
exception that allows patients in emergency, life-threatening
situations to receive experimental medical treatment without the
usual requirement of informed consent?
FISCAL EFFECT : As currently in print this bill is keyed
non-fiscal.
SYNOPSIS
Under existing federal and state law, human subjects generally
cannot be subject to medical experiments or experimental medical
procedures unless they give written, informed consent. However,
both federal and state law recognize an important exception to
this general rule in emergency, life-threatening situations
where the patient is in urgent need of treatment and is unable
to provide informed consent. The state law exception will
sunset on January 1, 2011. This non-controversial bill simply
extends that sunset date to January 1, 2014. The bill is
sponsored by the California Chapter of the American College of
Emergency Physicians. Supporters contend that, unless the
existing exemption is extended, patients may be precluded from
receiving lifesaving treatment solely because the treatment is
deemed experimental and the patient is unconscious or otherwise
unable to give informed consent. In 1997, California's
Protection of Human Subjects in Medical Experimentation Act,
following regulations promulgated by the U.S. Food and Drug
Administration, created both the general rule requiring written
informed consent for experimental treatment and, at the same
time, an exception for life-threatening situations. The
original exception provision had a sunset date of January 1,
2001, but this was extended to 2011 by SB 1188 (Committee on
Health and Human Services.) This bill would extend the sunset
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until January 1, 2014. The bill is supported by several medical
professional and research groups and institutions. There is no
known opposition. The bill passed out of two Senate committees
and off the Senate Floor without a dissenting vote. It most
recently passed unanimously out of the Assembly Health Committee
on its consent calendar.
SUMMARY : Extends, by three years, until January 1, 2014, the
sunset on a narrow exception to the informed consent provisions
of the Protection of Human Subjects in Medical Experimentation
Act, so as to permit patients with a life-threatening emergency
to receive an experimental medical treatment, as specified.
EXISTING LAW :
1)Establishes, under federal law, guidelines and procedures
regulating the use of human subjects in medical
experimentation that, among other things, require a patient's
written informed consent before that patient can be subject to
medical experiments or experimental medical procedures.
Provides, however, a narrow exception to the informed consent
requirement when the patient faces a life-threatening
emergency and consent cannot be feasibly obtained from either
the patient or a legal representative. (21 CFR Sections 50,
50.23, and 50.24.)
2)Provides various protections for human subjects of medical
research, including, but not limited to, a requirement that
the subject give a signed, written, conformed consent.
Requires further that the patient receive specified
disclosures regarding the medical experimentation and that the
patient understands his or her right to withdraw consent.
(Health & Safety Code Section 24173.)
3)Provides, until January 1, 2011, that the above consent and
disclosure requirements do not apply to any experimental
medical treatment that benefits a patient subject to a
life-threatening emergency if all of the following conditions
are met:
a) Care is provided in accordance with the procedures and
protections set forth in federal law, as specified.
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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 and there is not
time to obtain consent from a patient's legally authorized
representative.
d) There is no reasonable way to identify prospectively the
individual likely to become eligible for participation in
the clinical investigation.
e) Valid scientific studies have been conducted that
support the potential for the intervention to provide a
direct benefit to the patient and the risks associated with
the intervention are reasonable in light of the risks and
benefits of standard therapy, if any, and what is known
about the risks and benefits of the proposed intervention
or activity. (Health & Safety Code Section 24177.5 (a).
4)Specifies that nothing in the exemption noted above is
intended to relieve any party of any other legal duty,
including, but not limited to, the duty to act in a
non-negligent manner. (Health & Safety Code Section 24177.5
(b).)
5)Provides that the above provisions shall only remain in effect
until January 1, 2011, unless a later enacted statute extends
or deletes that date. (Health & Safety Code Section 24177.5
(c).)
COMMENTS : This non-controversial bill extends, by three years,
an exception to California's Protection of Human Subjects in
Medical Experimentation Act. That statute was enacted in 1997
shortly after the United States Food and Drug Administration
issued new rules relating to clinical trials and experimental
treatments involving human subjects. In general, those rules
required written, informed consent before a patient could take
part in a clinical trial or be subjected to experimental
treatments. However, the federal rules recognized an exception
in cases where the patient faced a life-threatening emergency
such that he or she could not give informed consent, or if there
were not time to obtain consent from a patient's legal
representative. The quite sensible rationale for the exception
was that a patient facing a life-threatening emergency should
not be denied the only treatment that might save his or her life
just because the procedure is deemed "experimental" and requires
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prior, informed consent. The federal rules specified that a
physician could only infer consent where the patient was in
critical condition and would very likely die without immediate
treatment.
In 1997 SB 160 (Watson, Chapter 68, Stats. of 1997) was enacted
in order to bring state law into compliance with the federal
rules, in the form of the Protection of Human Subjects and
Medical Experimentation Act (Health & Safety Code Sections 24170
et seq.) As with the federal rules, state law sets forth
regulations governing the use of human subjects in medical
experiments, including the general requirements for obtaining
informed consent. (Health & Safety Code Section 24175.)
However, also following the federal rules, state law creates an
exception for "any medical experimental treatment that benefits
a patient subject to a life-threatening emergency" as long as
several other conditions are met. The apparent purpose for the
exception, and the requisite conditions, is to ensure that a
person facing a life-threatening emergency will not be denied a
treatment just because it is deemed "experimental," while at the
same time making sure that persons are not subject to
experimental treatments that they might otherwise object to when
there are other proven and satisfactory treatments available.
The section containing the exception originally contained a
sunset date of January 1, 2001. SB 1188 (Chapter 122, Stats. of
2001) extended this sunset date to January 1, 2011. The author
and sponsor originally sought another ten year extension, until
2021. However, the Senate Judiciary Committee concluded that
there was not sufficient information to justify such a lengthy
extension, and the author agreed to a three-year extension of
the sunset.
ARGUMENTS IN SUPPORT : According to the author, this bill
extends a sunset on an existing and urgent exception that allows
patients in life-threatening situations to be subject to
experimental medical treatments without having to obtain the
usual prior informed consent. As the author writes, this narrow
exception allows "potentially life-saving treatments [to be]
administered after careful consideration of the patient's best
treatment options and can provide invaluable information on the
treatment of critically ill patients. Without this exception,
not only are patients who are unable to give informed consent
due to a life-threatening injury or illness prevented from
receiving life-saving treatment simply because the treatment is
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experimental, but an important opportunity to determine the
effectiveness of new treatment is lost."
The California Chapter of American College of Emergency
Physicians, the sponsor of this legislation, writes:
Extending or eliminating the sunset is important for
patients in California. 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. Without this narrow exception for
informed consent, California patients with such
life-threatening emergencies cannot take part in
clinical trials or treatments that have been shown to
have potential for providing direct patient benefit.
REGISTERED SUPPORT / OPPOSITION :
Support
American College of Emergency Physicians, California Chapter
(sponsor)
American Heart Association
American Stroke Association
BIOCOM
California Emergency Nurses Association
California Hospital Association
Emergency Nurses Association
Los Angeles Biomedical Research Institute
University of California
University of California, San Francisco
Opposition
None on file
Analysis Prepared by : Thomas Clark / JUD. / (916) 319-2334