BILL ANALYSIS                                                                                                                                                                                                    

                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair

          BILL NO:       SB 1187                                      
          AUTHOR:        Strickland                                   
          AMENDED:       April 29, 2010                              
          HEARING DATE:  May 5, 2010                                  
          8              7                                           
                             Human experimentation


          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. 

                             CHANGES TO EXISTING LAW  

          Existing federal law:
          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.  

          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.


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 2


          Existing state law:
          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  
                 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;
                 A requirement that the subject give a signed,  
               written, informed consent form for the procedures,  
               drugs, or devices that will be applied or taken;
                 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; and,
                 A right to give consent freely and without force,  
               fraud, duress, or undue influence.

          Establishes that the performance of a medical experiment  
          without a patient's informed consent is punishable by both  
          civil and criminal penalties.  

          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:  
                 Care must be provided in accordance with the  
               procedures and the additional protections of the  
               rights and welfare of the patient required by federal  
                 The patient is in a life-threatening situation,  
               necessitating urgent intervention, and available  
               treatments are unproven or unsatisfactory;
                 The patient is unable to give informed consent as a  
               result of the patient's medical condition;
                 Obtaining informed consent from the patient's  
               legally authorized representatives is not feasible  
               before the treatment must be administered;
                 There is no reasonable way to identify  
               prospectively the individuals likely to become  


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 3


               eligible for participation in the clinical  
               investigation; and 
                 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 IMPACT  

          This bill is keyed non-fiscal.

                            BACKGROUND AND DISCUSSION 

          The author 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, SB 1187 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.   

          Emergency clinical trials established by federal  
          In 1996, federal regulations carved out a narrow exception  
          to the informed consent requirements in order to facilitate  
          clinical trials of experimental, life-saving treatments in  
          situations where a patient's condition prevents him or her  
          from providing consent.  These federal regulations, which  
          are still in place, impose strict limits on when  
          experimental treatment may be administered without a  
          patient's informed consent in a clinical trial.  

          Among the conditions that must be met for the exception to  
          apply are that participation in emergency research must  
          hold out the prospect of direct benefit to the individual  
          subject.  In addition, the sponsor of the research must use  
          available data to identify the specific therapeutic window  
          during which the administration of the treatment to the  
          patient should be initiated.  The therapeutic window will  
          vary from study to study and is generally defined as the  


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 4


          time period based on available scientific evidence, during  
          administration of the experimental treatment might  
          reasonably produce a demonstrable clinical effect.  The  
          therapeutic window is important because it is also the  
          window of time during which the clinical physician must  
          make efforts to contact and, if feasible, obtain informed  
          consent from a patient's legally authorized representative.  
           In some cases, such as with patients in cardiac arrest,  
          the therapeutic window may be very short.  

          Institutional Review Board
          Sponsors of clinical trials generally must submit their  
          proposals for emergency research for which an exception  
          from informed consent is requested to an institution's  
          Institutional Review Board  (IRB), which has the authority  
          to review all studies performed at the institution.  The  
          IRB must provide an opportunity for community consultation  
          and public disclosure, to generally inform the surrounding  
          communities about the proposed clinical trial, as well as  
          its risks, and potential benefits.  The disclosures must  
          clearly inform the community that informed consent will not  
          be obtained for most patients who ultimately received the  
          experimental treatment.  The IRB is responsible for  
          listening to and considering the community's opinions and  
          concerns when deciding whether the proposed clinical trial  
          should be modified, approved, or disapproved.   
          When a sponsor receives information regarding these public  
          disclosures from an IRB, the sponsor must submit the  
          information to the U.S. Food and Drug Administration, which  
          maintains a docket on its website.  

          If a clinical trial is approved by the IRB for patients  
          whose medical conditions prevent them from providing  
          consent, the physician participating in the trial must  
          commit to attempt 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.  The  physician must do  
          this before administering experimental treatment without  
          informed consent.  
          IRBs must also ensure that there are procedures in place to  
          provide information about the clinical trial at the  


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 5


          earliest feasible opportunity to the patient, if he or she  
          recovers from the life-threatening condition, or to the  
          patient's legally authorized representative or family  
          member.  A patient, or the patient's representative, has  
          the option of discontinuing participation in the clinical  

          State law dealing with exception to informed consent  
          Legislation passed in 1997 created a limited exception to  
          the Protection of Human Subjects in Medical Experimentation  
          Act that allows a patient who is unable to give informed  
          consent as a result of his medical condition, to receive  
          experimental medical treatment in a life-threatening  
          emergency, provided specified conditions are met.  It  
          contained a three-year sunset to allow for monitoring of  
          the new exception to informed consent.  However, the bill  
          contained no reporting requirement and no information was  
          used by, or provided to, the Legislature for the purposes  
          of monitoring the exception.  At the end of the three year  
          sunset, the Legislature passed an urgency measure to extend  
          the sunset for the informed consent exception by ten years,  
          also with no reporting requirement.  

          It appears that relatively few clinical trials have been  
          conducted in California using this exception. The U.S. Food  
          and Drug Administration docket contains information on  
          three clinical trials conducted in California between 1997  
          and 2007 at Glendale Memorial Hospital, UC San Diego, and  

          According to a document received from the sponsor of SB  
          1187, three clinical trials utilizing the exception 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 sixteen other sites nationwide, which  
          is scheduled to end in 2012; another is a study to  
          determine which of two agents is most effective in the  
          treatment of pediatric status epilepticus, at UC Davis, as  
          well as in eleven other institutions, which is scheduled to  
          end in 2011;  the third trial is a study on progesterone in  
          the treatment of traumatic brain injury which is beginning  
          in seventeen hospitals in fifteen states, including UC San  
          Francisco, Stanford and Santa Clara Valley Medical Center,  
          and is scheduled to continue until 2015. 


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 6


          According to the document, a study on hypertonic  
          resuscitation following traumatic injury was started in  
          2003 and was conducted in 32 hospitals nationwide,  
          including UC San Diego.  The study was stopped by the  
          sponsor in 2009 because the trial showed that the new  
          treatment was no better than the standard treatment, and  
          continued enrollment was unlikely to change the outcome of  
          the study. 

          Impact of a Patient's Do Not Resuscitate Form
          A Do Not Resuscitate (DNR) Form is an official state  
          document, developed by the Emergency Medical Services  
          Authority and the California Medical Association, which  
          allows a patient with a life- threatening illness or injury  
          to forgo specific resuscitative measures that may keep him  
          or her alive.  These measures include: chest compressions;  
          assisted ventilation; defibrillation; and, cardiotonic  
          drugs, which stimulate the heart.  The form does not affect  
          the provision of other emergency medical care, including  
          treatment for pain, difficulty breathing, major bleeding,  
          or other medical conditions.  Many patients make their DNR  
          wishes officially known because they do not want to be  
          placed on life-assisting equipment in the event that their  
          heart or breathing ceases. 

          If a patient has executed a DNR form, it takes precedence  
          over emergency treatment, including treatment conducted as  
          part of a clinical trial.  A physician generally must not  
          administer the experimental treatment if he or she knows  
          about the patient's DNR.  However, in practice, emergency  
          physicians are not always aware that a DNR exists, and  
          attempt to resuscitate the patient.  Therefore, under the  
          exception created by this bill, there could be instances  
          when a patient receives experimental treatment as part of a  
          clinical trial against the patient's wishes to not be  
          Prior legislation
          SB 1188 (Committee on Health and Human Services), Chapter  
          122, Statutes of 2001, provides an exception from the  
          Medical Experimentation Act until January 1, 2011, for any  
          medical experimental treatment that benefits a patient  
          subject to a life-threatening emergency that is conducted  
          in accordance with prescribed requirements.


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 7


          SB 160 (Watson), Chapter 68, Statutes of 1997, provides an  
          exception from the Medical Experimentation Act until  
          January 1, 2001, for any medical experimental treatment  
          that benefits a patient subject to a life-threatening  
          emergency that is conducted in accordance with prescribed  

          Arguments in support
          The American College of Emergency Physicians, California  
          Chapter (CAL/ACEP), sponsor of the bill, 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 SB 1187  
          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  
          fourth largest health care delivery system in the state.   
          UC further states that it is one of the largest recipients  
          of National Institutes of Health (NIH) funding in the  
          nation for cutting-edge research.  UC contends that  
          providing complex critical care to California's medically  
          vulnerable population, and undertaking medical research are  
          two of its key missions, and SB 1187 would enable it to  
          continue these missions. 

          The California Hospital Association states that without SB  
          1187, 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  


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 8


           1)Bill double referred to Senate Judiciary Committee.  This  
            bill was referred to Senate 
          Judiciary Committee which passed it on a 4-0 vote on April  

          2) An evaluation of the exception should be conducted.  The  
          docket information and documents provided by the sponsor  
          listing the current clinical trials does not give enough  
          information for the Legislature to determine whether the  
          exception to the informed consent requirement has been used  
          to successfully administer life-saving experimental  
          treatments, or whether the exception has been abused. 

          For example, there is no specific information regarding  
          treatments used in each trial:the outcomes, the number of  
          patients treated without informed consent, and whether  
          patients actually benefited from the treatment.   
          Conceivably, the research conducted under the exception  
          could have helped save many lives in the past 10 years, but  
          there has not been enough information presented to support  
          any conclusion at this point.

          As noted, the exception to informed consent that is  
          addressed by this bill dates back to 1997 and SB 1187  
          represents the second extension of the exception.  However,  
          as noted, no formal studies or evaluation of the exception  
          have been made.  As a result of the lack of evaluation, the  
          bill was amended in the Senate Judiciary Committee to limit  
          the sunset extension to three years.  

          The sponsors of the bill may wish to consider, for the  
          purpose of future extension of the sunset for the informed  
          consent exception, conducting an evaluation of the clinical  
          trials in which medical experimental treatment without a  
          patient's informed consent in a life-threatening situation  
          was performed.  

                                 PRIOR ACTIONS

           Senate Judiciary Committee                      4-0

          Support:   California Chapter of the American College of  
          Emergency Physicians   


          STAFF ANALYSIS OF SENATE BILL  1187 (Strickland)Page 9


                            California Hospital Association
                            Emergency Nurses Association
                            Los Angeles Biomedical Research  
          Institute, Harbor UCLA Medical Center
                            University of California 

          Oppose:  None received

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