BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 58| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 58 Author: Wieckowski (D) Amended: 4/2/13 in Assembly Vote: 21 SENATE HEALTH COMMITTEE : 9-0, 6/5/13 AYES: Hernandez, Anderson, Beall, De León, DeSaulnier, Monning, Nielsen, Pavley, Wolk ASSEMBLY FLOOR : 76-0, 4/8/13 - See last page for vote SUBJECT : Medical experiments: human subjects SOURCE : California Chapter of the American College of Emergency Physicians DIGEST : This bill makes permanent an exemption in current law that permits, until January 1, 2014, patients in life-threatening emergencies to receive medical experimental treatment without informed consent if specified conditions are met; and adds specified conditions for the use of medical experimental treatments. ANALYSIS : Existing state law: 1.Establishes, under the Protection of Human Subjects in the Medical Experimentation Act (Act), various protections for subjects of medical experimentation relating to a bill of rights; informed consent procedures and documentation; and, CONTINUED AB 58 Page 2 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, 2014, any medical experimental treatment that benefits a patient subject to a life-threatening emergency if: A. Care is provided in accordance with the procedures and additional protections of the rights and welfare of the 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 representative 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 the intervention to provide a direct benefit to the patient. Existing federal law: 1.Establishes 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 to the above requirements to permit a limited class of research in emergency settings without consent if: CONTINUED AB 58 Page 3 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. This bill: 1.Makes permanent the exemption in current law that permits, until January 1, 2014, patients in life-threatening emergencies to receive medical experimental treatment without informed consent if specified conditions are met. 2.Adds the following to the conditions required for the use of medical experimental treatment: A. The IRB has reviewed and approved the informed consent procedures and these procedures are to be used with subjects or their legally authorized representatives in CONTINUED AB 58 Page 4 situations where use of the procedures and documents is feasible. B. Additional protections of the rights and welfare of the subjects will be provided, including, but not limited to: Consultation, including, where appropriate, consultation carried out by the IRB, with representatives of the communities in which the research will be conducted and from which the subjects will be drawn; Public disclosure to the communities in which the research will be conducted and from which the subjects will be drawn, prior to the initiation of the research, of plans for the research and its risks and expected benefits; Public disclosure of sufficient information following the completion of the research to apprise the community and researchers of the study, including demographic characteristics of the research population and the results of the study; and, Establishment of an independent data monitoring committee to exercise oversight of the research. Background Emergency care research. A 2012 booklet published by the American College of Emergency Physicians, entitled "Emergency Care Research: A Primer," states that emergency care research is research [that] focuses on the discovery and application of time-critical diagnostics, decision making and treatments that save lives, prevent or reduce disability, and restore human health. Since patients with these conditions are often unstable and incapable of providing consent and the treatments being studied take place in an ambulance or immediately on arrival in the emergency department, clinical trials of emergency care research can only be performed under federal regulations developed by the federal Food and Drug Administration that allow for an exception from informed consent for these emergency circumstances. According to information provided by the sponsor of this bill, the California Chapter of the American College of Emergency Physicians, approximately 15 studies to date have been CONTINUED AB 58 Page 5 performed since the federal exemption from informed consent was established in 1996. Research from these studies has focused on improving the timely delivery of known drugs or testing new treatment methods to improve the lives of emergency patients. One clinical trial utilizing the exemption is currently underway in three hospitals in California: UC San Francisco, Stanford, and Santa Clara Valley Medical Center. It is a study of the use of the hormone progesterone in the treatment of traumatic brain injury and is scheduled to continue until 2015. Federal informed consent requirements. Federal regulations related to the protection of human subjects in research generally prohibit an investigator from involving a human subject in research unless he or she has obtained the informed consent of the subject or the subject's legally authorized representative. Informed consent requirements can be waived for research activities involving human subjects in life-threatening situations defined as 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 apply 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. IRBs. The exemption from informed consent requirements for research in emergency settings in existing federal law is conditional upon documented findings by an IRB. The IRB is responsible for determining 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 has been requested is required to submit their research proposal to the 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 the public has been appropriately notified of plans for the investigation and its risks and expected benefits. The IRB is tasked with taking the community's opinions and concerns into consideration when deciding whether to modify, approve, or disapprove the proposed clinical trial. The IRB must also ensure that procedures are in place to provide information about the clinical trial at the earliest feasible opportunity to the patient, should he or she recover from the life-threatening condition, or to the patient's CONTINUED AB 58 Page 6 legally authorized representative. A patient, or the patient's representative, may opt to no longer participate at any point in the clinical trial. Prior Legislation SB 160 (Watson), Chapter 68, Statutes of 1997, established the exemption in state law until January 1, 2001. SB 1188 (Senate Health and Human Services Committee), Chapter 122, Statutes of 2001, extended the sunset to January 1, 2011. SB 1187 (Tony Strickland), Chapter 108, Statutes of 2010, extends to January 1, 2014, the sunset on the exception in current law that waives informed consent requirements for medical experimental treatment that benefits a patient in a life-threatening emergency, if specified conditions are met. FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local: No SUPPORT : (Verified 6/6/13) California Chapter of the American College of Emergency Physicians (source) BIOCOM California Healthcare Institute California State Council of Emergency Nurses Association Civil Justice Association of California Emergency Medical Services Administrators Association LA BioMed San Francisco Neurological Emergencies Treatment Trials Network Society for Academic Emergency Medicine University of California ARGUMENTS IN SUPPORT : The California Chapter of the American College of Emergency Physicians writes that, without this bill, life-saving research that protects patient rights and recognizes the potential for medical progress could no longer take place in California. Other supporters, such as the Society for Academic Emergency Medicine, the San Francisco Neurological Emergencies Treatment Trials Network, and University of California, note that the very narrow circumstances when urgent medical CONTINUED AB 58 Page 7 intervention can be delivered without informed consent allowed under existing state and federal law include sufficient safeguards for the rights of medically vulnerable patients and this bill will allow critical research to continue to be done to advance knowledge in treating critically ill or injured patients. LA BioMed points out that permanently lifting the sunset on this narrow exception will ensure that vital medical research continues to be conducted to develop and evaluate promising new therapies for Californians afflicted with sudden, unpredictable, and devastating injuries and illnesses that threaten their lives or lead to permanent disability. The Civil Justice Association of California adds that this bill is a common sense measure that reinforces the state's strong policy of encouraging the provision of emergency assistance and treatment. ASSEMBLY FLOOR : 76-0, 4/8/13 AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom, Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Cooley, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox, Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hernández, Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Maienschein, Medina, Melendez, Mitchell, Morrell, Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson, Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone, Ting, Torres, Wagner, Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Conway, Lowenthal, Mansoor, Vacancy JL:nl 6/6/13 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED