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  


          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  


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          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.


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             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  
             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  

          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  

           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  


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          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  

          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  


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          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.  


          American College of Emergency Physicians, California Chapter  
          American Heart Association
          American Stroke Association 
          California Emergency Nurses Association
          California Hospital Association
          Emergency Nurses Association 
          Los Angeles Biomedical Research Institute 
          University of California 
          University of California, San Francisco
          None on file

           Analysis Prepared by  :    Thomas Clark / JUD. / (916) 319-2334