BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                  SB 1187|
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                                 THIRD READING


          Bill No:  SB 1187
          Author:   Strickland (R)
          Amended:  4/29/10
          Vote:     21

           
           SENATE JUDICIARY COMMITTEE  :  4-0, 4/27/10
          AYES:  Corbett, Hancock, Leno, Walters
          NO VOTE RECORDED:  Harman

           SENATE HEALTH COMMITTEE  :  9-0, 5/5/10
          AYES:  Alquist, Strickland, Aanestad, Cedillo, Cox, Leno,  
            Negrete McLeod, Pavley, Romero


           SUBJECT  :    Human experimentation

           SOURCE  :     American College of Emergency Physicians,  
          California 
                      Chapter


           DIGEST  :    This bill extends, until January 1, 2014, an  
          existing exception to the Protection of Human Subjects in  
          Medical Experimentation Act, under which medical  
          experimental treatment may be provided to a patient without  
          the patient's informed consent in a life-threatening  
          situation, if prescribed conditions are met. 

           ANALYSIS  :    

          Existing federal law:

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          1. Establishes general procedures and protections  
             pertaining to the use of human subjects in medical  
             experimentation, which includes obtaining informed  
             consent from a subject or a subject's legally authorized  
             representative.  Unauthorized medical treatment is  
             punishable by both civil and criminal penalties.  

          2. Provides a narrow exception to the informed consent  
             requirements if both the investigator and a physician,  
             who is not otherwise participating in the clinical  
             investigation, certify in writing, that specified  
             conditions are met, which includes that a subject is  
             confronted by a life-threatening situation necessitating  
             the use of the experimental treatment.

          Existing state law:

          1. Provides protections for subjects of medical  
             experimentation and penalties for violations of those  
             provisions under the Protection of Human Subjects in  
             Medical Experimentation Act (Act).  These protections  
             include:

             A.    A bill of rights for subjects of medical  
                experimentation, written in a language in which the  
                subject is fluent, and a requirement that the subject  
                receive a copy.

             B.    A requirement that the subject give a signed,  
                written, informed consent form for the procedures,  
                drugs, or devices that will be applied or taken.

             C.    A  requirement that specified disclosures be  
                provided, including the right to withdraw consent;  
                affiliation and identification of persons conducting  
                the experiment; sponsor funding source or  
                manufacturer of the experiment; and a third party to  
                whom a subject may direct complaints.

             D.    A right to give consent freely and without force,  
                fraud, duress, or undue influence.

          2. Establishes that the performance of a medical experiment  
             without a patient's informed consent is punishable by  







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             both civil and criminal penalties.  

          3. Provides an exception from the Act, until January 1,  
             2011, for any medical experimental treatment that  
             benefits a patient who is subject to a life-threatening  
             emergency, if prescribed conditions are met.  These  
             conditions include the following:  

             A.    Care must be provided in accordance with the  
                procedures and the additional protections of the  
                rights and welfare of the patient required 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.

             F.    Valid scientific studies have been conducted that  
                support the potential for intervention to provide a  
                direct benefit to the patient.

          This bill extends the exception under which medical  
          experimental treatment may be provided to a patient without  
          the patient's informed consent in a life-threatening  
          situation, if prescribed conditions are met, until January  
          1, 2014. 

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  No    
          Local:  No

           SUPPORT  :   (Verified  5/6/10)








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           American College of Emergency Physicians, California  
            Chapter (source)
          California Hospital Association
          Emergency Nurses Association
          Los Angeles Biomedical Research Institute, Harbor UCLA  
          Medical Center
          University of California 


           ARGUMENTS IN SUPPORT  :    The author's office states that  
          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.  According to the author's  
          office, this bill is needed to ensure that critical,  
          life-saving research can continue in California, which will  
          lead to saving lives and providing better emergency care  
          for numerous patients.   

          The American College of Emergency Physicians, California  
          Chapter (CAL/ACEP), the bill's sponsor, argues that in an  
          effort to allow clinical research in emergency settings  
          when informed consent is not feasible, the federal  
          government created stringent guidelines to allow for these  
          types of clinical trials.  CAL/ACEP contends that this bill  
          is needed to continue to allow life-saving research in  
          life-threatening situations to take place in California.  

          Los Angeles Biomedical Research Institute (LA BioMed) adds  
          that California law is generally more restrictive than  
          federal law, and may block life-saving research, without  
          the exception that would be extended by this bill.  LA  
          BioMed argues that the incompatibility between state and  
          federal law is why the exception to the Act was put into  
          place years ago.

          The University of California (UC) states that it operates  
          medical centers in Davis, Los Angeles, Irvine, San Diego,  
          and San Francisco and that the UC clinical enterprise is  
          the fourth largest health care delivery system in the  
          state.  UC further states that it is one of the largest  
          recipients of NIH funding in the nation for cutting-edge  
          research.  UC contends that providing complex critical care  
          to California's medically vulnerable population, and  







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          undertaking medical research are two of its key missions,  
          and this bill will enable it to continue these missions. 

          The California Hospital Association states that without  
          this bill, patients who are unable to give informed consent  
          due to a medical condition will be precluded from receiving  
          what might be life-saving treatment because it is  
          experimental. 


          RJG:mw  5/6/10   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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