BILL ANALYSIS
SB 1187
Page 1
Date of Hearing: June 15, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1187 (Tony Strickland) - As Amended: April 29, 2010
SENATE VOTE : 33-0
SUBJECT : Human experimentation.
SUMMARY : Extends, to January 1, 2014, the sunset in existing
law that waives informed consent requirements for medical
experimental treatment provided to patients in life-threatening
emergencies under specified conditions.
EXISTING FEDERAL LAW :
1)Prescribes 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:
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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.
4)Imposes civil and criminal penalties for performing
unauthorized medical treatment.
EXISTING STATE LAW :
1)Establishes the Protection of Human Subjects in Medical
Experimentation Act (Act) which sets forth 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, 2011, 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
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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 representatives 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 intervention to provide a direct
benefit to the patient.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . The author states that existing law has
enabled vital research relating to resuscitating individuals
from cardiac arrest, stabilizing children experiencing
uncontrolled seizures, and controlling bleeding and shock in
trauma patients, to be conducted that has helped save lives
and provide better emergency care for numerous patients. The
author notes that, in 1996, in an effort to allow clinical
research to be conducted in emergency situations when informed
consent is not feasible while also protecting the rights of
patients, the federal government enacted stringent guidelines
to allow clinical trials to move forward in the event informed
consent could not be obtained from patients in life
threatening situations. The author points out that current
state law conforms to federal regulations governing the
conduct of emergency research where an exception from informed
consent is needed but it is due to sunset in 2011. The author
argues that allowing current law to sunset will put an end to
critical life-saving research in California. This bill seeks
to extend the sunset in order to continue the narrow exception
that allows patients in life-threatening situations to
participate in experimental trials that have shown potential
for direct patient benefit and ensure that important
opportunities to determine the effectiveness of new treatments
are not lost.
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2)BACKGROUND . Federal regulations for the protection of human
beings in research require informed consent, with a few
limited exceptions. Generally, an investigator is prohibited
from involving a human being as a subject 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 that 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 and
informed consent, whether oral or written, is prohibited from
including any language through 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.
In 1996 the federal Department of Health and Human Services and
Food and Drug Administration published criteria to allow
informed consent requirements to be waived for a limited class
of research in emergency situations. The exception applies to
a limited class of research activities involving human
subjects who in a life-threatening situation requiring
intervention before consent from a legally authorized
representative is feasible. Life-threatening includes
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
informed consent to apply in emergency research 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 effect. The therapeutic window is also
important because it is used as the window of time during
which the clinical physician must attempt to contact and, if
feasible, obtain informed consent from a patient's legally
authorized representative. In some instances, such as a
patient experiencing cardiac arrest or a stroke, the
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therapeutic window may be very short.
3)INSTITUTIONAL REVIEW BOARDS . The exception from informed
consent requirements permitted for research in emergency
settings is conditional upon documented findings by an IRB.
Specifically, the IRB is responsible for deciding 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 to informed consent has been
requested is required to submit their proposal for emergency
research to an 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 information regarding plans for the investigation
and its risks and expected benefits are publicly disclosed.
The disclosures are required to clearly notify the community
that informed consent will not be obtained for most patients
in the trial who ultimately receive the experimental
treatment. The IRB is responsible for listening to and
considering the community's opinions and concerns when
deciding whether to modify, approve, or disapprove the
proposed 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 by the sponsor of the research, as an
advisory body to the sponsor, 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.
If a clinical trial is approved by an IRB for patients whose
medical conditions prevent them from providing consent, the
physician participating in the trial is required to commit to
making an effort 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 prior to administering
experimental treatment without informed consent. IRBs must
also ensure that procedures are in place to provide
information about the clinical trial at the earliest feasible
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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 in the
clinical trial.
4)CURRENT CLINICAL TRIALS . According to background information
from the author's office, three clinical trials utilizing the
exemption 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 16 other sites nationwide,
that is scheduled to end in 2012; another is a study to
determine which of two agents is most effective in treating
pediatric status epilepticus, at UC Davis, as well as in 11
other institutions, that is scheduled to end in 2011; and, the
third trial is a study on progesterone in the treatment of
traumatic brain injury which is beginning in 17 hospitals in
15 states, including UC San Francisco, Stanford, and Santa
Clara Valley Medical Center, and it is scheduled to continue
until 2015. Another study on hypertonic resuscitation
following traumatic injury was initiated in 2003 and conducted
in 32 hospitals nationwide, including UC San Diego, but
stopped by the sponsor in 2009 because the trial showed that
the new treatment was no more effective than the standard
treatment, and continued enrollment was unlikely to change the
outcome of the study.
5)PRIOR LEGISLATION .
a) SB 1188 (Committee on Health and Human Services),
Chapter 122, Statutes of 2001, extends to January 1, 2011,
the sunset on the existing exception for any medical
experimental treatment that benefits a patient subject to a
life-threatening emergency that is conducted in accordance
with prescribed requirements from informed consent
provisions of the Act.
b) SB 160 (Watson), Chapter 68, Statutes of 1997, exempts
any medical experimental treatment that benefits a patient
subject to a life-threatening emergency, if specified
conditions are met, from the informed consent requirements
of the Act until January 1, 2001.
6)DOUBLE REFERRAL . This bill has been double referred. Should
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this bill pass this committee, it will be referred to the
Assembly Judiciary Committee.
7)SUPPORT . The sponsor of this bill, the California Chapter of
the American College of Emergency Physicians, states that
extending the sunset for an exception to informed consent in
emergency research is important in ensuring that patients in
California with life threatening emergencies caused by trauma
or cardiac arrest can continue to take part in clinical trials
of treatments that have been shown to have potential for
providing direct patient benefit. Supporters, representing
emergency nurses, hospitals, and biomedical researchers, write
that unless the sunset date is extended, patients who are
unable to give informed consent due to a medical condition
will be precluded from receiving what is possibly lifesaving
treatment solely because the treatment is experimental and
this bill will save lives by ensuring treatment is provided to
patients who cannot consent. The American Heart Association
adds in support that research conducted in emergency settings
is important to advance knowledge in treating critically ill
patients and has helped to improve emergency care for heart
disease and stroke patients.
REGISTERED SUPPORT / OPPOSITION :
Support
American College of Emergency Physicians, California Chapter
(sponsor)
American Heart Association
BIOCOM
California Emergency Nurses Association
California Hospital Association
Los Angeles Biomedical Research Institute
University of California
One individual
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097