BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 58
AUTHOR: Wieckowski
AMENDED: April 2, 2013
HEARING DATE: June 5, 2013
CONSULTANT: Moreno
SUBJECT : Medical experiments: human subjects.
SUMMARY : 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. Adds
specified conditions for the use of medical experimental
treatments.
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,
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,
Continued---
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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:
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.
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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
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:
i. 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;
ii. 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;
iii. 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,
iv. Establishment of an independent data monitoring
committee to exercise oversight of the research.
FISCAL EFFECT : This bill has been keyed non-fiscal.
PRIOR VOTES :
Assembly Health: 19- 0
Assembly Floor: 76- 0
COMMENTS :
1.Author's statement. It is difficult for medical researchers
to rigorously study emergency medical interventions for the
treatment of acute, time-sensitive conditions, such as heart
attacks, stroke, shock states, seizures, and traumatic brain
injury, in clinical trials because patients with these
conditions are often unresponsive and unable to consent to
participate in research. 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. Federal law governing this
exemption from informed consent does not contain a sunset and
AB 58 | Page 4
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. 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.
2.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 (FDA) 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 (California ACEP), approximately 15 studies to date
have been 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.
3.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
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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. While there is
no set time for a therapeutic window, it is generally
identified as the time period, based on available scientific
evidence, during which administration of the experimental
treatment might reasonably produce a demonstrable clinical
benefit. The therapeutic window is used as the period of time
during which the investigator must attempt to contact and, if
feasible, obtain informed consent from a patient's legally
authorized representative.
4.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 legally authorized
representative. A patient, or the patient's representative,
may opt to no longer participate at any point in the clinical
trial.
5.Prior legislation. SB 160 (Watson), Chapter 68, Statutes of
1997, established the exemption in state law until January 1,
2001.
SB 1188 (Committee on Health and Human Services), Chapter 122,
Statutes of 2001, extended the sunset to January 1, 2011.
SB 1187 (Tony Strickland), Chapter 108, Statutes of 2010,
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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.
6.Support. California ACEP 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 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.
SUPPORT AND OPPOSITION :
Support: American College of Emergency Physicians, California
Chapter (sponsor)
BIOCOM
California Healthcare Institute
California State Council of Emergency Nurses
Association
Civil Justice Association of California
Emergency Medical Services Administrators Association
LABioMed
San Francisco Neurological Emergencies Treatment
Trials
Society for Academic Emergency Medicine
University of California
Oppose:None received
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