BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



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                                    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,  
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            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:

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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.

          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  

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               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  

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          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  

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          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  

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          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

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