BILL ANALYSIS
SENATE JUDICIARY COMMITTEE
Senator Ellen M. Corbett, Chair
2009-2010 Regular Session
SB 1187 (Strickland)
As Introduced
Hearing Date: April 27, 2010
Fiscal: No
Urgency: No
KB
SUBJECT
Human Experimentation
DESCRIPTION
This bill, sponsored by the California Chapter of the American
College of Emergency Physicians, would, until January 1, 2021,
extend the exemption in the Protection of Human Subjects in
Medical Experimentation Act that authorizes the use of medical
experimental treatment without a patient's informed consent if
it benefits a patient subject to a life-threatening emergency.
BACKGROUND
In 1996, the U.S. Food and Drug Administration (FDA) and the
Department of Health and Human Services created new regulations
to permit clinical trials to be conducted where informed consent
cannot be obtained from patients facing life-threatening
situations. Those regulations provided a very narrow exception
to the requirement of obtaining the informed consent from a
patient. A physician may only infer informed consent where the
patient is in critical condition and will deteriorate and pass
away without immediate treatment. These regulations were the
result of over two years of public testimony and discussion
forums held around the nation.
In order to comply with these federal regulations, the
Legislature enacted SB 160 (Watson, Chapter 68, Statutes of
1997), which created an exception to the Protection of Human
Subjects in Medical Experimentation Act for medical experimental
treatment that benefits a patient subject to a life-threatening
emergency, under specified conditions. SB 160 contained a
three-year sunset provision, which expired on January 1, 2001,
(more)
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in order to monitor the impact of the exception.
In 2001, SB 1188 (Committee on Health and Human Services)
extended the exception for another ten years, until January 1,
2011 in order to keep state law in compliance with federal
regulations. This bill would extend the sunset for an
additional ten years.
CHANGES TO EXISTING LAW
Existing federal law establishes general procedures and
protections pertaining to the use of human subjects in medical
experimentation. Existing federal law contains a narrow
exception to these general requirements where a patient's
informed consent cannot be obtained because he or she is in a
life-threatening situation. (21 CFR 50; 21 CFR 50.23; 45 CFR
46.)
Existing law , the Protection of Human Subjects in Medical
Experimentation Act (Act), provides protections for subjects of
medical experimentation and penalties for violations of those
provisions. (Health & Saf. Code Sec. 24173.) These protections
include:
(1) a bill of rights for subjects of medical experimentation,
written in a language in which the subject is fluent;
(2) a requirement that a subject receive a copy of the bill of
rights;
(3) a requirement that the subject give a signed, written,
informed consent for the procedures, drugs, or devices that
would be applied or taken;
(4) a requirement for specified disclosures regarding the
medical experimentation, including the right to withdraw
consent, affiliation, and address of the person or persons
conducting the experiment, the name of the sponsor or
funding source or manufacturer of the experiment, and the
name, address, and phone number of an impartial third party
to whom the subject may direct complaints; and
(5) a right to give consent freely and without force, fraud,
duress, or undue influence.
Existing law provides an exception from the Act, until January
1, 2011, for any medical experimental treatment that benefits a
patient subject to a life-threatening emergency if prescribed
conditions are met. (Health & Saf. Code Sec. 24177.5.)
Specifically, existing law requires that:
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(1) care must be provided in accordance with the procedures
and the additional protections of the rights and welfare of
the patient set forth in federal regulations;
(2) the patient is in a life-threatening situation
necessitating urgent intervention and available treatments
are unproven or unsatisfactory;
(3) the patient is unable to give informed consent as a
result of the patient's medical condition;
(4) obtaining informed consent from the patient's legally
authorized representatives is not feasible before the
treatment must be administered;
(5) there is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in
the clinical investigation; and
(6) valid scientific studies have been conducted that
support the potential for intervention to provide a direct
benefit to the patient.
This bill would extend the exception until January 1, 2021.
COMMENT
1.Stated need for the bil l
The author states:
Under existing law, vital research has been conducted to
resuscitation from cardiac arrest, stabilizing uncontrolled
seizures in children, improving CPR, and controlling bleeding
and shock in trauma patients. This research has helped [to]
save lives and provide better emergency care for numerous
patients.
In 1996, in an effort to allow clinical research in emergency
settings when informed consent is not feasible while
simultaneously protecting rights of the patients, the
Department of Health and Human Services and the Food and Drug
Administration created stringent guidelines to allow clinical
trials when informed consent could not be obtained from
patients in life threatening situations. The federal law
imposes additional requirements and patient protections, even
beyond those which are mandatory to perform other clinical
trials.
The author states that this bill would extend the sunset that
conforms California law to federal regulations pertaining to the
use of medical experimentation for patients in a
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life-threatening situation. The author asserts that critical,
live-saving research will cease to continue in California if
this law is allowed to sunset.
Additionally, the University of California writes in support:
UC operates medical centers in Davis, Los Angeles, Irvine, San
Diego, and San Francisco. The UC clinical enterprise is the
fourth largest healthcare delivery system in the state and
staffs five trauma centers throughout California. On an
annual basis, we see approximately 284,000 patients in our
emergency department. The University is also one of the
largest recipients of National Institutes of Health (NIH)
funding in the nation for cutting edge research. The
provision of complex critical care to California's medically
vulnerable population and the undertaking of medical research
are two of the key missions of the University of California.
SB 1187 would enable us to continue to fulfill our mission to
and for the people of California.
2.Parameters for clinical trials established by federal
regulations
The doctrine of informed consent provides that a patient must be
informed of the risks and benefits of proposed medical
treatment, and of alternative courses of treatment.
In the absence of the patient giving informed consent,
unauthorized medical treatment constitutes the tort of battery.
In addition, under the Protection of Human Subjects in Medical
Experimentation Act (Act), the performance of a medical
experiment without a patient's informed consent is punishable by
both civil and criminal penalties. (Health & Saf. Code Sec.
24176.)
As previously discussed, the 1996 federal regulations carved out
a narrow exception to the informed consent requirement in order
to facilitate clinical trials of experimental, life-saving
treatments in situations where a patient's condition prevents
him/her from providing consent. These federal regulations are
still in place, and impose strict parameters, described below,
on when experimental treatment may be administered without a
patient's informed consent in a clinical trial. (21 CFR 50.24.)
Participation in emergency research must hold out the prospect
of direct benefit to the individual subject. The sponsor of the
research must use available data to identify the therapeutic
window during which the administration of the treatment to the
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patient should be initiated. The therapeutic window will vary
from study to study and is generally defined as the time period
based on available scientific evidence, during which
administration of the experimental treatment might reasonably
produce a demonstrable clinical effect. The therapeutic window
is important because it is also the window of time during which
the clinical physician must make efforts to contact and, if
feasible, obtain informed consent from a patient's legally
authorized representative. In some cases, such as with patients
in cardiac arrests, the therapeutic window may be very short.
Sponsors of a clinical trial will submit their proposals for
emergency research for which an exception from informed consent
is requested to an institution's Institutional Review Board
(IRB) which has the authority to review all studies performed at
the institution. Pursuant to 21 CFR 50.24, the IRB must provide
an opportunity for community consultation and public disclosure
to generally inform the surrounding communities about the
proposed clinical trial, its risks, and potential benefits. The
disclosures should also clearly inform the community that
informed consent will not be obtained for most patients who
ultimately received the experimental treatment. The IRB is
responsible for listening to and considering the community's
opinions and concerns when deciding whether the proposed
clinical trial should be modified, approved, or disapproved.
When a sponsor receives information regarding public disclosures
from an IRB, the sponsor must submit the information to the U.S.
Food and Drug Administration, which maintains a docket on its
Web site (available at http://www.fda.gov/ohrms/dockets/
/95s0158/95s0158.htm.) (21 CFR 56.109(g); 21 CFR 812.47(a).)
If a clinical trial is approved by the IRB for patients whose
medical conditions prevent them from providing consent, the
physician participating in the trial must commit to attempt to
seek written informed consent, if feasible, from a legally
authorized representative of the patient. If no representative
is available, the physician must provide an opportunity for a
family member to object to the participation of a patient. The
physician must do this before administering experimental
treatment without informed consent. (21 CFR 50.24(a)(7)(v).)
Furthermore, IRBs must ensure that there are procedures in place
to provide information about the clinical trial, at the earliest
feasible opportunity to the patient if he or she recovers from
the life-threatening condition, or to the patient's legally
authorized representative or family member. A patient (or the
patient's representative) has the option of discontinuing
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participation in the clinical trial.
3.Impact of a Patient's Do Not Resuscitate Form
A Do Not Resuscitate (DNR) Form is an official State document
developed by the California EMS Authority and the California
Medical Association which allows a patient with a life
threatening illness or injury to forgo specific resuscitative
measures that may keep him or her alive. These measures
include: chest compressions (CPR); assisted ventilation
(breathing); defibrillation; and cardiotonic drugs (drugs which
stimulate the heart). The form does not affect the provision of
other emergency medical care, including treatment for pain (also
known as "comfort measures"), difficulty breathing, major
bleeding, or other medical conditions. Many patients make their
DNR wishes officially known because they do not want to be
placed on life-assisting equipment in the event that their heart
or breathing ceases.
If a patient has executed a DNR form then it should take
precedence over the emergency research conducted in a clinical
trial. In other words, a physician would not administer the
experimental treatment if he or she knows about the patient's
DNR. However, in practice, emergency physicians are not always
aware that a DNR exists, and therefore will attempt to
resuscitate the patient. Therefore, pursuant to the exception
created by this bill, there may be instances when a patient
receives experimental treatment as part of a clinical trial
against the patient's wishes to not be resuscitated.
This committee may wish to inquire of the author and sponsor
whether they are aware of any instances where this has happened
and what protocols are followed in cases where a patient has
executed a DNR.
4.Lack of information to support a lengthy sunset
When SB 160 was first enacted it contained a three-year sunset
to allow for monitoring of the new exception to informed
consent. However, no reporting requirement was added to the
bill along with the sunset, thus it is unclear what information
was to be used by or provided to the Legislature for the
purposes of monitoring the new exception. At the end of the
three year sunset, SB 1188 was passed as an urgency measure to
extend the sunset for the informed consent exception by ten
years, also with no reporting requirement.
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Committee staff notes that ten years is atypically long for a
sunset extension. Sunsets are usually shorter time periods and
are generally accompanied by a reporting requirement so as to
enable the Legislature to monitor whether the statute or program
is having its intended effect or whether unanticipated
consequences have arisen. With this particular exception to the
Protection of Human Subjects in Medical Experimentation Act, no
reports were ever mandated (possibly because there is no central
repository for this information), nor does it appear that any
reports were voluntarily compiled by the hospitals or physicians
administering clinical trials under the statute.
According to the sponsor, the research and clinical trials
utilizing the exception to informed consent have decreased
because of the stringent requirements in federal regulations.
In particular, many proposals are ultimately rejected by IRBs
because the degree of community consultation conducted by the
sponsor is not sufficient. Committee staff notes that the
docket on the U.S. Food and Drug Administration contains
information on three clinical trials conducted in California
between 1997 and 2007 at Glendale Memorial Hospital, UC San
Diego, and UCLA. The sponsor additionally notes that research
is currently being conducted by UC San Francisco and UC Davis
that focuses on which treatments are more beneficial to children
who suffer from seizures. This information does seem to
indicate the clinical trials that utilize the exception to
informed consent are not frequently taking place.
However, the docket information alone is not enough to permit
the Legislature to determine whether the exception to the
informed consent requirement has been used to successfully
administer life-saving experimental treatments, or whether the
exception has been abused. For example, there is no specific
information regarding the exact treatments used in each trial,
the exact outcomes, the number of patients treated without
informed consent, and whether patients actually benefited from
the treatment. Conceivably, the research conducted under the
exception could have helped save many lives in the past ten
years, but there has not been enough information presented to
support any conclusion at this point.
In light of this lack of information and because of the serious
nature of administering medical treatment without a patient's
informed consent, this Committee may wish to consider whether a
shorter sunset extension, such as three years, is more
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appropriate. This would keep the exception intact to allow for
the completion of the trial in progress and would provide the
proponents of this measure with additional time to compile the
information necessary to demonstrate to the Legislature whether
a longer sunset is warranted.
Suggested amendment:
On page 2, line 31, strike "2021" and insert "2014"
On page 2, line 32, strike "2021" and insert "2014"
Support : California Emergency Nurses Association; California
Hospital Association; Los Angeles Biomedical Research Institute;
University of California; one individual
Opposition : None Known
HISTORY
Source : California Chapter of the American College of Emergency
Physicians
Related Pending Legislation : None Known
Prior Legislation : See Background
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