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: SB 1187 Page 2 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 SB 1187 Page 3 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. SB 1187 Page 4 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 SB 1187 Page 5 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 SB 1187 Page 6 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 SB 1187 Page 7 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