BILL ANALYSIS SB 1187 Page 1 Date of Hearing: June 22, 2010 ASSEMBLY COMMITTEE ON JUDICIARY Mike Feuer, Chair SB 1187 (Strickland) - As Amended: April 29, 2010 Proposed Consent SENATE VOTE : 33-0 SUBJECT : Human Experimentation KEY ISSUE : Should the sunset be extended on the existing exception that allows patients in emergency, life-threatening situations to receive experimental medical treatment without the usual requirement of informed consent? FISCAL EFFECT : As currently in print this bill is keyed non-fiscal. SYNOPSIS Under existing federal and state law, human subjects generally cannot be subject to medical experiments or experimental medical procedures unless they give written, informed consent. However, both federal and state law recognize an important exception to this general rule in emergency, life-threatening situations where the patient is in urgent need of treatment and is unable to provide informed consent. The state law exception will sunset on January 1, 2011. This non-controversial bill simply extends that sunset date to January 1, 2014. The bill is sponsored by the California Chapter of the American College of Emergency Physicians. Supporters contend that, unless the existing exemption is extended, patients may be precluded from receiving lifesaving treatment solely because the treatment is deemed experimental and the patient is unconscious or otherwise unable to give informed consent. In 1997, California's Protection of Human Subjects in Medical Experimentation Act, following regulations promulgated by the U.S. Food and Drug Administration, created both the general rule requiring written informed consent for experimental treatment and, at the same time, an exception for life-threatening situations. The original exception provision had a sunset date of January 1, 2001, but this was extended to 2011 by SB 1188 (Committee on Health and Human Services.) This bill would extend the sunset SB 1187 Page 2 until January 1, 2014. The bill is supported by several medical professional and research groups and institutions. There is no known opposition. The bill passed out of two Senate committees and off the Senate Floor without a dissenting vote. It most recently passed unanimously out of the Assembly Health Committee on its consent calendar. SUMMARY : Extends, by three years, until January 1, 2014, the sunset on a narrow exception to the informed consent provisions of the Protection of Human Subjects in Medical Experimentation Act, so as to permit patients with a life-threatening emergency to receive an experimental medical treatment, as specified. EXISTING LAW : 1)Establishes, under federal law, guidelines and procedures regulating the use of human subjects in medical experimentation that, among other things, require a patient's written informed consent before that patient can be subject to medical experiments or experimental medical procedures. Provides, however, a narrow exception to the informed consent requirement when the patient faces a life-threatening emergency and consent cannot be feasibly obtained from either the patient or a legal representative. (21 CFR Sections 50, 50.23, and 50.24.) 2)Provides various protections for human subjects of medical research, including, but not limited to, a requirement that the subject give a signed, written, conformed consent. Requires further that the patient receive specified disclosures regarding the medical experimentation and that the patient understands his or her right to withdraw consent. (Health & Safety Code Section 24173.) 3)Provides, until January 1, 2011, that the above consent and disclosure requirements do not apply to any experimental medical 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 protections set forth in federal law, as specified. SB 1187 Page 3 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 and there is not time to obtain consent from a patient's legally authorized representative. d) There is no reasonable way to identify prospectively the individual likely to become eligible for participation in the clinical investigation. e) Valid scientific studies have been conducted that support the potential for the intervention to provide a direct benefit to the patient and the risks associated with the intervention are reasonable in light of the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity. (Health & Safety Code Section 24177.5 (a). 4)Specifies that nothing in the exemption noted above is intended to relieve any party of any other legal duty, including, but not limited to, the duty to act in a non-negligent manner. (Health & Safety Code Section 24177.5 (b).) 5)Provides that the above provisions shall only remain in effect until January 1, 2011, unless a later enacted statute extends or deletes that date. (Health & Safety Code Section 24177.5 (c).) COMMENTS : This non-controversial bill extends, by three years, an exception to California's Protection of Human Subjects in Medical Experimentation Act. That statute was enacted in 1997 shortly after the United States Food and Drug Administration issued new rules relating to clinical trials and experimental treatments involving human subjects. In general, those rules required written, informed consent before a patient could take part in a clinical trial or be subjected to experimental treatments. However, the federal rules recognized an exception in cases where the patient faced a life-threatening emergency such that he or she could not give informed consent, or if there were not time to obtain consent from a patient's legal representative. The quite sensible rationale for the exception was that a patient facing a life-threatening emergency should not be denied the only treatment that might save his or her life just because the procedure is deemed "experimental" and requires SB 1187 Page 4 prior, informed consent. The federal rules specified that a physician could only infer consent where the patient was in critical condition and would very likely die without immediate treatment. In 1997 SB 160 (Watson, Chapter 68, Stats. of 1997) was enacted in order to bring state law into compliance with the federal rules, in the form of the Protection of Human Subjects and Medical Experimentation Act (Health & Safety Code Sections 24170 et seq.) As with the federal rules, state law sets forth regulations governing the use of human subjects in medical experiments, including the general requirements for obtaining informed consent. (Health & Safety Code Section 24175.) However, also following the federal rules, state law creates an exception for "any medical experimental treatment that benefits a patient subject to a life-threatening emergency" as long as several other conditions are met. The apparent purpose for the exception, and the requisite conditions, is to ensure that a person facing a life-threatening emergency will not be denied a treatment just because it is deemed "experimental," while at the same time making sure that persons are not subject to experimental treatments that they might otherwise object to when there are other proven and satisfactory treatments available. The section containing the exception originally contained a sunset date of January 1, 2001. SB 1188 (Chapter 122, Stats. of 2001) extended this sunset date to January 1, 2011. The author and sponsor originally sought another ten year extension, until 2021. However, the Senate Judiciary Committee concluded that there was not sufficient information to justify such a lengthy extension, and the author agreed to a three-year extension of the sunset. ARGUMENTS IN SUPPORT : According to the author, this bill extends a sunset on an existing and urgent exception that allows patients in life-threatening situations to be subject to experimental medical treatments without having to obtain the usual prior informed consent. As the author writes, this narrow exception allows "potentially life-saving treatments [to be] administered after careful consideration of the patient's best treatment options and can provide invaluable information on the treatment of critically ill patients. Without this exception, not only are patients who are unable to give informed consent due to a life-threatening injury or illness prevented from receiving life-saving treatment simply because the treatment is SB 1187 Page 5 experimental, but an important opportunity to determine the effectiveness of new treatment is lost." The California Chapter of American College of Emergency Physicians, the sponsor of this legislation, writes: Extending or eliminating the sunset is important for patients in California. 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. Without this narrow exception for informed consent, California patients with such life-threatening emergencies cannot take part in clinical trials or treatments that have been shown to have potential for providing direct patient benefit. REGISTERED SUPPORT / OPPOSITION : Support American College of Emergency Physicians, California Chapter (sponsor) American Heart Association American Stroke Association BIOCOM California Emergency Nurses Association California Hospital Association Emergency Nurses Association Los Angeles Biomedical Research Institute University of California University of California, San Francisco Opposition None on file Analysis Prepared by : Thomas Clark / JUD. / (916) 319-2334