BILL ANALYSIS �
AB 58
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Date of Hearing: March 19, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 58 (Wieckowski) - As Amended: February 27, 2013
SUBJECT : Medical experiments: human subjects.
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.
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;
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
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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 from general requirements governing
informed consent of human subjects when both the investigator
and a physician who is not otherwise participating in the
clinical investigation certify all of the following in
writing:
a) The human subject is confronted by a life-threatening
situation necessitating the use of experimental treatment;
b) Informed consent cannot be obtained from the subject
because of an inability to communicate with, or obtain
legally effective consent from, the subject;
c) Time is not sufficient to obtain consent from the
subject's legal representative; and,
d) There is no available alternative method of approved or
generally recognized therapy that provides an equal or
greater likelihood of saving the life of the subject.
3)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
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
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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.
4)Imposes civil and criminal penalties for performing
unauthorized medical treatment.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . 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.
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 characterized by its focus on the timing, severity and
acute sensitivity of certain critical conditions, such as
stroke, trauma, shock, cardiac arrest, and respiratory
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failure, and the treatments capable of halting or reversing
them. Because 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 a
list 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)EXISTING INFORMED CONSENT REQUIREMENTS . Federal regulations
for the protection of human subjects in research generally
prohibit an investigator from involving individuals in
research unless the investigator has obtained the legally
effective informed consent of the subject or the subject's
legally authorized representative. An investigator is
required to seek such consent only under circumstances that
provide the potential subject or the representative sufficient
opportunity to consider whether or not to participate and
minimize the possibility of coercion or undue influence.
Information given to the subject or the representative must be
in language that is understandable to the subject or the
representative. Informed consent, whether oral or written, is
prohibited from including any language in which the subject or
the representative is made to waive, or appear to waive, any
of the subject's rights, or to release, or appear to release,
the investigator, the sponsor, the institution, or its agents
from liability for negligence.
Federal criteria allowing informed consent requirements to be
waived for research activities involving human subjects in
life-threatening situations define life-threatening as
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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. 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 also
important because it is used as the window of time during
which the investigator must attempt to contact and, if
feasible, obtain informed consent from a patient's legally
authorized representative. Additionally, in order for any
emergency care research to qualify for the exemption, the
community where the research is being conducted must be
consulted and notified through various forms of public
disclosure, such as via the newspaper, radio, television,
community newsletter, and/or a public website, that informed
consent will not be obtained for most study enrollees.
The subject of this bill is unrelated to a recent controversy
surrounding two neurosurgeons from the University of
California, Davis (UC Davis) who performed an experimental
procedure on patients with brain cancer. In these cases, the
neurosurgeons obtained informed consent from the patients but
what was not communicated to the patients was that the
procedure had not been approved by the FDA as an
investigational new treatment for testing in human subjects or
by UC Davis' IRB. In response to these incidences, UC Davis
has since instituted an "anti-innovative use" policy that
expressly prohibits any use of a non-FDA approved drug,
biologic, or device without formal IRB and, as required, FDA
approval, regardless of the purpose of the use.
4)IRBs . The exception from informed consent requirements for
research in emergency settings 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
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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.
Additionally, the IRB must find and document that an independent
data monitoring committee has been established to exercise
oversight of the clinical investigation. The data monitoring
committee is established as an advisory body by the sponsor of
the research and is comprised of individuals not otherwise
connected with the particular clinical investigation. The
committee is responsible for ensuring the ongoing safety of
current and prospective trial subjects as well as monitoring
the continuing validity and scientific merit of the trial.
5)SUPPORT . California ACEP 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
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sense measure that reinforces the state's strong policy of
encouraging the provision of emergency assistance and
treatment.
6)PRIOR LEGISLATION .
a) 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.
b) SB 1188 (Committee on Health and Human Services),
Chapter 122, Statutes of 2001, extended the sunset to
January 1, 2011.
c) SB 160 (Watson), Chapter 68, Statutes of 1997,
established the exemption in state law until January 1,
2001.
7)AUTHOR'S AMENDMENTS . The author will offer the following
amendments in committee to mirror existing federal
requirements governing the exemption from informed consent for
emergency research relating to the role of the IRB, community
consultation, public disclosure, and establishment of an
independent data monitoring committee to oversee the research:
On page 2, below line 33 insert:
(7) The institutional review board (IRB) has
reviewed and approved informed consent procedures
and these procedures are to be used with subjects or
their legally authorized representatives in
situations where use of such procedures is feasible.
(8) Additional protections of the rights and welfare
of the subjects will be provided, including, at
least:
(a) 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
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subjects will be drawn;
(b) public disclosure to the communities
in which the research will be conducted and from
which the subjects will be drawn, prior to
initiation of the research, of plans for the
research and its risks and expected benefits;
(c) public disclosure of sufficient
information following completion of the research to
apprise the community and researchers of the study,
including the demographic characteristics of the
research population, and its results; and,
(d) establishment of an independent data
monitoring committee to exercise oversight of the
research.
REGISTERED SUPPORT / OPPOSITION :
Support
California Chapter of the American College of Emergency
Physicians (sponsor)
BIOCOM
Civil Justice Association of California
Los Angeles Biomedical Research Institute
San Francisco Neurological Emergencies Treatment Trials Network
Society for Academic Emergency Medicine
University of California
Opposition
None on file.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097