BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 1187
S
AUTHOR: Strickland
B
AMENDED: April 29, 2010
HEARING DATE: May 5, 2010
1
CONSULTANT:
1
Tadeo/
8 7
SUBJECT
Human experimentation
SUMMARY
Extends, until January 1, 2014, an existing exception to
the Protection of Human Subjects in Medical Experimentation
Act, under which medical experimental treatment may be
provided to a patient without the patient's informed
consent in a life-threatening situation, if prescribed
conditions are met.
CHANGES TO EXISTING LAW
Existing federal law:
Establishes general procedures and protections pertaining
to the use of human subjects in medical experimentation,
which includes obtaining informed consent from a subject or
a subject's legally authorized representative.
Unauthorized medical treatment is punishable by both civil
and criminal penalties.
Provides a narrow exception to the informed consent
requirements if both the investigator and a physician, who
is not otherwise participating in the clinical
investigation, certify in writing, that specified
conditions are met, which includes that a subject is
confronted by a life-threatening situation necessitating
the use of the experimental treatment.
Continued---
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 2
Existing state law:
Provides protections for subjects of medical
experimentation and penalties for violations of those
provisions under the Protection of Human Subjects in
Medical Experimentation Act (Act). These protections
include:
A bill of rights for subjects of medical
experimentation, written in a language in which the
subject is fluent, and a requirement that the subject
receive a copy;
A requirement that the subject give a signed,
written, informed consent form for the procedures,
drugs, or devices that will be applied or taken;
A requirement that specified disclosures be
provided, including the right to withdraw consent;
affiliation and identification of persons conducting
the experiment; sponsor funding source or manufacturer
of the experiment; and a third party to whom a subject
may direct complaints; and,
A right to give consent freely and without force,
fraud, duress, or undue influence.
Establishes that the performance of a medical experiment
without a patient's informed consent is punishable by both
civil and criminal penalties.
Provides an exception from the Act, until January 1, 2011,
for any medical experimental treatment that benefits a
patient who is subject to a life-threatening emergency, if
prescribed conditions are met. These conditions include
the following:
Care must be provided in accordance with the
procedures and the additional protections of the
rights and welfare of the patient required by federal
regulations;
The patient is in a life-threatening situation,
necessitating urgent intervention, and available
treatments are unproven or unsatisfactory;
The patient is unable to give informed consent as a
result of the patient's medical condition;
Obtaining informed consent from the patient's
legally authorized representatives is not feasible
before the treatment must be administered;
There is no reasonable way to identify
prospectively the individuals likely to become
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 3
eligible for participation in the clinical
investigation; and
Valid scientific studies have been conducted that
support the potential for intervention to provide a
direct benefit to the patient.
This bill:
Extends the exception under which medical experimental
treatment may be provided to a patient without the
patient's informed consent in a life-threatening situation,
if prescribed conditions are met, until January 1, 2014.
FISCAL IMPACT
This bill is keyed non-fiscal.
BACKGROUND AND DISCUSSION
The author states that researchers in emergency medicine
and other specialties are trying to discover better
treatments for critically ill patients, including those
needing resuscitation due to trauma or cardiac arrest.
According to the author, SB 1187 is needed to ensure that
critical, life-saving research can continue in California,
which will lead to saving lives and providing better
emergency care for numerous patients.
Emergency clinical trials established by federal
regulations
In 1996, federal regulations carved out a narrow exception
to the informed consent requirements in order to facilitate
clinical trials of experimental, life-saving treatments in
situations where a patient's condition prevents him or her
from providing consent. These federal regulations, which
are still in place, impose strict limits on when
experimental treatment may be administered without a
patient's informed consent in a clinical trial.
Among the conditions that must be met for the exception to
apply are that participation in emergency research must
hold out the prospect of direct benefit to the individual
subject. In addition, the sponsor of the research must use
available data to identify the specific therapeutic window
during which the administration of the treatment to the
patient should be initiated. The therapeutic window will
vary from study to study and is generally defined as the
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 4
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 arrest,
the therapeutic window may be very short.
Institutional Review Board
Sponsors of clinical trials generally must 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. The
IRB must provide an opportunity for community consultation
and public disclosure, to generally inform the surrounding
communities about the proposed clinical trial, as well as
its risks, and potential benefits. The disclosures must
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 these 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 website.
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.
IRBs must also ensure that there are procedures in place to
provide information about the clinical trial at the
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 5
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 participation in the clinical
trial.
State law dealing with exception to informed consent
requirements
Legislation passed in 1997 created a limited exception to
the Protection of Human Subjects in Medical Experimentation
Act that allows a patient who is unable to give informed
consent as a result of his medical condition, to receive
experimental medical treatment in a life-threatening
emergency, provided specified conditions are met. It
contained a three-year sunset to allow for monitoring of
the new exception to informed consent. However, the bill
contained no reporting requirement and no information was
used by, or provided to, the Legislature for the purposes
of monitoring the exception. At the end of the three year
sunset, the Legislature passed an urgency measure to extend
the sunset for the informed consent exception by ten years,
also with no reporting requirement.
It appears that relatively few clinical trials have been
conducted in California using this exception. The U.S. Food
and Drug Administration docket contains information on
three clinical trials conducted in California between 1997
and 2007 at Glendale Memorial Hospital, UC San Diego, and
UCLA.
According to a document received from the sponsor of SB
1187, three clinical trials utilizing the exception from
informed consent are currently in process in hospitals in
California: one is a study to compare the effectiveness of
two seizure-stopping medications, at Stanford and UC San
Francisco, as well as sixteen other sites nationwide, which
is scheduled to end in 2012; another is a study to
determine which of two agents is most effective in the
treatment of pediatric status epilepticus, at UC Davis, as
well as in eleven other institutions, which is scheduled to
end in 2011; the third trial is a study on progesterone in
the treatment of traumatic brain injury which is beginning
in seventeen hospitals in fifteen states, including UC San
Francisco, Stanford and Santa Clara Valley Medical Center,
and is scheduled to continue until 2015.
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According to the document, a study on hypertonic
resuscitation following traumatic injury was started in
2003 and was conducted in 32 hospitals nationwide,
including UC San Diego. The study was stopped by the
sponsor in 2009 because the trial showed that the new
treatment was no better than the standard treatment, and
continued enrollment was unlikely to change the outcome of
the study.
Impact of a Patient's Do Not Resuscitate Form
A Do Not Resuscitate (DNR) Form is an official state
document, developed by the Emergency Medical Services
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;
assisted ventilation; defibrillation; and, cardiotonic
drugs, which stimulate the heart. The form does not affect
the provision of other emergency medical care, including
treatment for pain, 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, it takes precedence
over emergency treatment, including treatment conducted as
part of a clinical trial. A physician generally must 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
attempt to resuscitate the patient. Therefore, under the
exception created by this bill, there could be instances
when a patient receives experimental treatment as part of a
clinical trial against the patient's wishes to not be
resuscitated.
Prior legislation
SB 1188 (Committee on Health and Human Services), Chapter
122, Statutes of 2001, provides an exception from the
Medical Experimentation Act until January 1, 2011, for any
medical experimental treatment that benefits a patient
subject to a life-threatening emergency that is conducted
in accordance with prescribed requirements.
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 7
SB 160 (Watson), Chapter 68, Statutes of 1997, provides an
exception from the Medical Experimentation Act until
January 1, 2001, for any medical experimental treatment
that benefits a patient subject to a life-threatening
emergency that is conducted in accordance with prescribed
requirements.
Arguments in support
The American College of Emergency Physicians, California
Chapter (CAL/ACEP), sponsor of the bill, argues that in an
effort to allow clinical research in emergency settings
when informed consent is not feasible, the federal
government created stringent guidelines to allow for these
types of clinical trials. CAL/ACEP contends that SB 1187
is needed to continue to allow life-saving research in
life-threatening situations to take place in California.
Los Angeles Biomedical Research Institute (LA BioMed) adds
that California law is generally more restrictive than
federal law, and may block life-saving research, without
the exception that would be extended by this bill. LA
BioMed argues that the incompatibility between state and
federal law is why the exception to the Act was put into
place years ago.
The University of California (UC) states that it operates
medical centers in Davis, Los Angeles, Irvine, San Diego,
and San Francisco and that the UC clinical enterprise is
the
fourth largest health care delivery system in the state.
UC further states that it is one of the largest recipients
of National Institutes of Health (NIH) funding in the
nation for cutting-edge research. UC contends that
providing complex critical care to California's medically
vulnerable population, and undertaking medical research are
two of its key missions, and SB 1187 would enable it to
continue these missions.
The California Hospital Association states that without SB
1187, patients who are unable to give informed consent due
to a medical condition will be precluded from receiving
what might be life-saving treatment because it is
experimental.
COMMENTS
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 8
1)Bill double referred to Senate Judiciary Committee. This
bill was referred to Senate
Judiciary Committee which passed it on a 4-0 vote on April
27.
2) An evaluation of the exception should be conducted. The
docket information and documents provided by the sponsor
listing the current clinical trials does not give enough
information for 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
treatments used in each trial:the 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 10 years, but
there has not been enough information presented to support
any conclusion at this point.
As noted, the exception to informed consent that is
addressed by this bill dates back to 1997 and SB 1187
represents the second extension of the exception. However,
as noted, no formal studies or evaluation of the exception
have been made. As a result of the lack of evaluation, the
bill was amended in the Senate Judiciary Committee to limit
the sunset extension to three years.
The sponsors of the bill may wish to consider, for the
purpose of future extension of the sunset for the informed
consent exception, conducting an evaluation of the clinical
trials in which medical experimental treatment without a
patient's informed consent in a life-threatening situation
was performed.
PRIOR ACTIONS
Senate Judiciary Committee 4-0
POSITIONS
Support: California Chapter of the American College of
Emergency Physicians
STAFF ANALYSIS OF SENATE BILL 1187 (Strickland)Page 9
(sponsor)
California Hospital Association
Emergency Nurses Association
Los Angeles Biomedical Research
Institute, Harbor UCLA Medical Center
University of California
Oppose: None received
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