BILL ANALYSIS �
AB 58
Page 1
ASSEMBLY THIRD READING
AB 58 (Wieckowski)
As Amended April 2, 2013
Majority vote
HEALTH 19-0
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|Ayes:|Pan, Logue, Ammiano, |
| |Atkins, Bonilla, Bonta, |
| |Chesbro, Gomez, Roger |
| |Hern�ndez, Rendon, |
| |Maienschein, Mansoor, |
| |Mitchell, Nazarian, |
| |Nestande, |
| |V. Manuel P�rez, Wagner, |
| |Wieckowski, Wilk |
| | |
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SUMMARY : Makes permanent an exemption in current law that
allows, until January 1, 2014, patients in life-threatening
emergencies to receive medical experimental treatment without
informed consent if specified conditions are met in accordance
with federal law.
EXISTING STATE LAW :
1)Establishes the Protection of Human Subjects in Medical
Experimentation Act (Act) which prescribes various protections
for subjects of medical experimentation relating to a bill of
rights; informed consent procedures and documentation; and,
the provision of specified disclosures, including the right
for a subject to give or withdraw consent freely and without
duress. Imposes penalties for violations of these
protections.
2)Exempts from the Act, until January 1, 2014, any medical
experimental 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
additional protections of the rights and welfare of the
patient established by federal regulations;
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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;
d) Obtaining informed consent from the patient's legally
authorized representative 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; and,
f) Valid scientific studies have been conducted that
support the potential for the intervention to provide a
direct benefit to the patient.
EXISTING FEDERAL LAW :
1)Establishes various procedures and protections relating to the
use of human subjects in medical research, including a
requirement that an investigator obtain the legally effective
informed consent of the subject or the subject's legally
authorized representative prior to involving a human being as
a subject in research.
2)Establishes a narrow exception to existing informed consent
requirements to permit a limited class of research in
emergency settings without consent under the following
criteria:
a) The human subjects are in a life-threatening situation;
b) Obtaining consent is not feasible;
c) Participation in the research holds out the prospect of
direct benefit to the subjects;
d) The clinical investigation could not practicably be
carried out without the waiver of consent;
e) The proposed investigational plan defines the length of
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the potential therapeutic window based on scientific
evidence, and the investigator has committed to attempting
to contact a legally authorized representative for each
subject within that window of time and, if feasible, to
asking the legally authorized representative contacted for
consent within that window, rather than proceeding without
consent;
f) Informed consent procedures and documents have been
reviewed and approved by an institutional review board and
used with subjects or their legally authorized
representatives in situations where use of such procedures
and documents is feasible; and,
g) Additional protections of the rights and welfare of
subjects will be provided, including specified
consultations, public disclosures, and the establishment of
an independent data monitoring committee.
3)Imposes civil and criminal penalties for performing
unauthorized medical treatment.
FISCAL EFFECT : None
COMMENTS : According to the author, few emergency medical
interventions for the treatment of acute, time-sensitive
conditions, such as heart attacks, stroke, shock states,
seizures, and traumatic brain injury, have been rigorously
studied in clinical trials because patients with these
conditions are often unresponsive and unable to consent to
participate in research. The author argues that this bill
aligns state law with federal requirements for emergency care
research studies where informed consent cannot be obtained from
patients experiencing these life-threatening conditions. The
author notes that federal law governing this exemption from
informed consent does not contain a sunset and this same narrow
exception has been granted in California for the last 15 years,
providing ample time to extensively demonstrate the benefits of
this research without any evidence of harm. The author states
that this bill is needed to remove the sunset and allow
critical, potentially life-saving emergency care research
studies to continue to be performed in rare instances where an
exception to informed consent is necessary.
The sponsor of this bill, the California Chapter of the American
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College of Emergency Physicians, writes in support that, without
this bill, life-saving research that protects patient rights and
recognizes the potential for medical progress could no longer
take place in California. Other supporters, such as the Society
for Academic Emergency Medicine, the San Francisco Neurological
Emergencies Treatment Trials Network, and University of
California, note that the very narrow circumstances when urgent
medical intervention can be delivered without informed consent
allowed under existing state and federal law include sufficient
safeguards for the rights of medically vulnerable patients and
this bill will allow critical research to continue to be done to
advance knowledge in treating critically ill or injured
patients. The Los Angeles Biomedical Research Institute points
out that permanently lifting the sunset on this narrow exception
will ensure that vital medical research continues to be
conducted to develop and evaluate promising new therapies for
Californians afflicted with sudden, unpredictable, and
devastating injuries and illnesses that threaten their lives or
lead to permanent disability. The Civil Justice Association of
California adds that this bill is a common sense measure that
reinforces the state's strong policy of encouraging the
provision of emergency assistance and treatment.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097
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