BILL ANALYSIS �
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THIRD READING
Bill No: AB 58
Author: Wieckowski (D)
Amended: 4/2/13 in Assembly
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 6/5/13
AYES: Hernandez, Anderson, Beall, De Le�n, DeSaulnier, Monning,
Nielsen, Pavley, Wolk
ASSEMBLY FLOOR : 76-0, 4/8/13 - See last page for vote
SUBJECT : Medical experiments: human subjects
SOURCE : California Chapter of the American College of
Emergency
Physicians
DIGEST : This bill makes permanent an exemption in current law
that permits, until January 1, 2014, patients in
life-threatening emergencies to receive medical experimental
treatment without informed consent if specified conditions are
met; and adds specified conditions for the use of medical
experimental treatments.
ANALYSIS : Existing state law:
1.Establishes, under the Protection of Human Subjects in the
Medical Experimentation Act (Act), various protections for
subjects of medical experimentation relating to a bill of
rights; informed consent procedures and documentation; and,
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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:
A. Care is provided in accordance with the procedures and
additional protections of the rights and welfare of the
patient established 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 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.Provides an exception to the above requirements to permit a
limited class of research in emergency settings without
consent if:
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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
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
(IRB) 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.
This bill:
1.Makes permanent the exemption in current law that permits,
until January 1, 2014, patients in life-threatening
emergencies to receive medical experimental treatment without
informed consent if specified conditions are met.
2.Adds the following to the conditions required for the use of
medical experimental treatment:
A. The IRB has reviewed and approved the informed consent
procedures and these procedures are to be used with
subjects or their legally authorized representatives in
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situations where use of the procedures and documents is
feasible.
B. Additional protections of the rights and welfare of the
subjects will be provided, including, but not limited to:
Consultation, including, where appropriate,
consultation carried out by the IRB, with representatives
of the communities in which the research will be
conducted and from which the subjects will be drawn;
Public disclosure to the communities in which the
research will be conducted and from which the subjects
will be drawn, prior to the initiation of the research,
of plans for the research and its risks and expected
benefits;
Public disclosure of sufficient information
following the completion of the research to apprise the
community and researchers of the study, including
demographic characteristics of the research population
and the results of the study; and,
Establishment of an independent data monitoring
committee to exercise oversight of the research.
Background
Emergency care research. A 2012 booklet published by the
American College of Emergency Physicians, entitled "Emergency
Care Research: A Primer," states that emergency care research is
research [that] focuses on the discovery and application of
time-critical diagnostics, decision making and treatments that
save lives, prevent or reduce disability, and restore human
health. Since patients with these conditions are often unstable
and incapable of providing consent and the treatments being
studied take place in an ambulance or immediately on arrival in
the emergency department, clinical trials of emergency care
research can only be performed under federal regulations
developed by the federal Food and Drug Administration that allow
for an exception from informed consent for these emergency
circumstances. According to information provided by the sponsor
of this bill, the California Chapter of the American College of
Emergency Physicians, approximately 15 studies to date have been
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performed since the federal exemption from informed consent was
established in 1996. Research from these studies has focused on
improving the timely delivery of known drugs or testing new
treatment methods to improve the lives of emergency patients.
One clinical trial utilizing the exemption is currently underway
in three hospitals in California: UC San Francisco, Stanford,
and Santa Clara Valley Medical Center. It is a study of the use
of the hormone progesterone in the treatment of traumatic brain
injury and is scheduled to continue until 2015.
Federal informed consent requirements. Federal regulations
related to the protection of human subjects in research
generally prohibit an investigator from involving a human
subject in research unless he or she has obtained the informed
consent of the subject or the subject's legally authorized
representative. Informed consent requirements can be waived for
research activities involving human subjects in life-threatening
situations defined as diseases or conditions where the
likelihood of death is high unless the course of the disease or
condition is interrupted. Among the criteria that must be met
for the exception to apply is the requirement that the sponsor
of the research use available data to specify the therapeutic
window during which the administration of the treatment to the
patient should be initiated.
IRBs. The exemption from informed consent requirements for
research in emergency settings in existing federal law is
conditional upon documented findings by an IRB. The IRB is
responsible for determining whether or not the criteria for
allowing research in emergency situations without consent have
been met. The sponsor of a clinical trial for which an
exception has been requested is required to submit their
research proposal to the IRB. The IRB must consult with
representatives of the communities in which the clinical
investigations will be conducted and from which the subjects
will be drawn to ensure that the public has been appropriately
notified of plans for the investigation and its risks and
expected benefits. The IRB is tasked with taking the
community's opinions and concerns into consideration when
deciding whether to modify, approve, or disapprove the proposed
clinical trial. The IRB must also ensure that procedures are in
place to provide information about the clinical trial at the
earliest feasible opportunity to the patient, should he or she
recover from the life-threatening condition, or to the patient's
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legally authorized representative. A patient, or the patient's
representative, may opt to no longer participate at any point in
the clinical trial.
Prior Legislation
SB 160 (Watson), Chapter 68, Statutes of 1997, established the
exemption in state law until January 1, 2001.
SB 1188 (Senate Health and Human Services Committee), Chapter
122, Statutes of 2001, extended the sunset to January 1, 2011.
SB 1187 (Tony Strickland), Chapter 108, Statutes of 2010,
extends to January 1, 2014, the sunset on the exception in
current law that waives informed consent requirements for
medical experimental treatment that benefits a patient in a
life-threatening emergency, if specified conditions are met.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local:
No
SUPPORT : (Verified 6/6/13)
California Chapter of the American College of Emergency
Physicians (source)
BIOCOM
California Healthcare Institute
California State Council of Emergency Nurses Association
Civil Justice Association of California
Emergency Medical Services Administrators Association
LA BioMed
San Francisco Neurological Emergencies Treatment Trials Network
Society for Academic Emergency Medicine
University of California
ARGUMENTS IN SUPPORT : The California Chapter of the American
College of Emergency Physicians writes 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
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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. LA BioMed 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.
ASSEMBLY FLOOR : 76-0, 4/8/13
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Ch�vez, Chesbro, Cooley,
Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox, Frazier,
Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell, Gray,
Grove, Hagman, Hall, Harkey, Roger Hern�ndez, Holden, Jones,
Jones-Sawyer, Levine, Linder, Logue, Maienschein, Medina,
Melendez, Mitchell, Morrell, Mullin, Muratsuchi, Nazarian,
Nestande, Olsen, Pan, Patterson, Perea, V. Manuel P�rez,
Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone, Ting,
Torres, Wagner, Waldron, Weber, Wieckowski, Wilk, Williams,
Yamada, John A. P�rez
NO VOTE RECORDED: Conway, Lowenthal, Mansoor, Vacancy
JL:nl 6/6/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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