BILL ANALYSIS                                                                                                                                                                                                    

                                                                  SB 1187
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          Date of Hearing:   June 15, 2010

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
               SB 1187 (Tony Strickland) - As Amended:  April 29, 2010

           SENATE VOTE  :  33-0
          SUBJECT  :  Human experimentation.

           SUMMARY  :  Extends, to January 1, 2014, the sunset in existing  
          law that waives informed consent requirements for medical  
          experimental treatment provided to patients in life-threatening  
          emergencies under specified conditions.  


          1)Prescribes 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 from general requirements governing  
            informed consent of human subjects when both the investigator  
            and a physician who is not otherwise participating in the  
            clinical investigation certify all of the following in  

             a)   The human subject is confronted by a life-threatening  
               situation necessitating the use of experimental treatment;
             b)   Informed consent cannot be obtained from the subject  
               because of an inability to communicate with, or obtain  
               legally effective consent from, the subject; 
             c)   Time is not sufficient to obtain consent from the  
               subject's legal representative; and,
             d)   There is no available alternative method of approved or  
               generally recognized therapy that provides an equal or  
               greater likelihood of saving the life of the subject.

          3)Establishes a narrow exception to existing informed consent  
            requirements to permit a limited class of research in  
            emergency settings without consent under the following  


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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  
             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.

          4)Imposes civil and criminal penalties for performing  
            unauthorized medical treatment.

           EXISTING STATE LAW  :

          1)Establishes the Protection of Human Subjects in Medical  
            Experimentation Act (Act) which sets forth various protections  
            for subjects of medical experimentation relating to a bill of  
            rights, informed consent procedures and documentation, and 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, 2011, any medical  
            experimental 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  
               additional protections of the rights and welfare of the  


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               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 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; and, 
             f)   Valid scientific studies have been conducted that  
               support the potential for intervention to provide a direct  
               benefit to the patient.

           FISCAL EFFECT :   None

           COMMENTS  : 

           1)PURPOSE OF THIS BILL  .  The author states that existing law has  
            enabled vital research relating to resuscitating individuals  
            from cardiac arrest, stabilizing children experiencing  
            uncontrolled seizures, and controlling bleeding and shock in  
            trauma patients, to be conducted that has helped save lives  
            and provide better emergency care for numerous patients.  The  
            author notes that, in 1996, in an effort to allow clinical  
            research to be conducted in emergency situations when informed  
            consent is not feasible while also protecting the rights of  
            patients, the federal government enacted stringent guidelines  
            to allow clinical trials to move forward in the event informed  
            consent could not be obtained from patients in life  
            threatening situations.  The author points out that current  
            state law conforms to federal regulations governing the  
            conduct of emergency research where an exception from informed  
            consent is needed but it is due to sunset in 2011.  The author  
            argues that allowing current law to sunset will put an end to  
            critical life-saving research in California.  This bill seeks  
            to extend the sunset in order to continue the narrow exception  
            that allows patients in life-threatening situations to  
            participate in experimental trials that have shown potential  
            for direct patient benefit and ensure that important  
            opportunities to determine the effectiveness of new treatments  
            are not lost.


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           2)BACKGROUND  .  Federal regulations for the protection of human  
            beings in research require informed consent, with a few  
            limited exceptions.  Generally, an investigator is prohibited  
            from involving a human being as a subject in research unless  
            the investigator has obtained the legally effective informed  
            consent of the subject or the subject's legally authorized  
            representative.  An investigator is required to seek such  
            consent only under circumstances that provide the potential  
            subject or the representative sufficient opportunity to  
            consider whether or not to participate and that minimize the  
            possibility of coercion or undue influence. Information given  
            to the subject or the representative must be in language that  
            is understandable to the subject or the representative and  
            informed consent, whether oral or written, is prohibited from  
            including any language through which the subject or the  
            representative is made to waive or appear to waive any of the  
            subject's rights, or to release or appear to release the  
            investigator, the sponsor, the institution, or its agents from  
            liability for negligence.

          In 1996 the federal Department of Health and Human Services and  
            Food and Drug Administration published criteria to allow  
            informed consent requirements to be waived for a limited class  
            of research in emergency situations.  The exception applies to  
            a limited class of research activities involving human  
            subjects who in a life-threatening situation requiring  
            intervention before consent from a legally authorized  
            representative is feasible.  Life-threatening includes  
            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  
            informed consent to apply in emergency research 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.  While there is no set time for a therapeutic  
            window, it is generally identified as the time period, based  
            on available scientific evidence, during which administration  
            of the experimental treatment might reasonably produce a  
            demonstrable clinical effect.  The therapeutic window is also  
            important because it is used as the window of time during  
            which the clinical physician must attempt to contact and, if  
            feasible, obtain informed consent from a patient's legally  
            authorized representative.  In some instances, such as a  
            patient experiencing cardiac arrest or a stroke, the  


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            therapeutic window may be very short.

           3)INSTITUTIONAL REVIEW BOARDS  .  The exception from informed  
            consent requirements permitted for research in emergency  
            settings is conditional upon documented findings by an IRB.   
            Specifically, the IRB is responsible for deciding 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 to informed consent has been  
            requested is required to submit their proposal for emergency  
            research to an 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 information regarding plans for the investigation  
            and its risks and expected benefits are publicly disclosed.   
            The disclosures are required to clearly notify the community  
            that informed consent will not be obtained for most patients  
            in the trial who ultimately receive the experimental  
            treatment.  The IRB is responsible for listening to and  
            considering the community's opinions and concerns when  
            deciding whether to modify, approve, or disapprove the  
            proposed clinical trial.

          Additionally, the IRB must find and document that an independent  
            data monitoring committee has been established to exercise  
            oversight of the clinical investigation.  The data monitoring  
            committee is established by the sponsor of the research, as an  
            advisory body to the sponsor, and is comprised of individuals  
            not otherwise connected with the particular clinical  
            investigation.  The committee is responsible for ensuring the  
            ongoing safety of current and prospective trial subjects as  
            well as monitoring the continuing validity and scientific  
            merit of the trial.

          If a clinical trial is approved by an IRB for patients whose  
            medical conditions prevent them from providing consent, the  
            physician participating in the trial is required to commit to  
            making an effort 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 prior to administering  
            experimental treatment without informed consent.  IRBs must  
            also ensure that procedures are in place to provide  
            information about the clinical trial at the earliest feasible  


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            opportunity to the patient, should he or she recover from the  
            life-threatening condition, or to the patient's legally  
            authorized representative.  A patient, or the patient's  
            representative, may opt to no longer participate in the  
            clinical trial.

           4)CURRENT CLINICAL TRIALS  .  According to background information  
            from the author's office, three clinical trials utilizing the  
            exemption 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 16 other sites nationwide,  
            that is scheduled to end in 2012; another is a study to  
            determine which of two agents is most effective in treating  
            pediatric status epilepticus, at UC Davis, as well as in 11  
            other institutions, that is scheduled to end in 2011; and, the  
            third trial is a study on progesterone in the treatment of  
            traumatic brain injury which is beginning in 17 hospitals in  
            15 states, including UC San Francisco, Stanford, and Santa  
            Clara Valley Medical Center, and it is scheduled to continue  
            until 2015.  Another study on hypertonic resuscitation  
            following traumatic injury was initiated in 2003 and conducted  
            in 32 hospitals nationwide, including UC San Diego, but  
            stopped by the sponsor in 2009 because the trial showed that  
            the new treatment was no more effective than the standard  
            treatment, and continued enrollment was unlikely to change the  
            outcome of the study.    

           5)PRIOR LEGISLATION  .

             a)   SB 1188 (Committee on Health and Human Services),  
               Chapter 122, Statutes of 2001, extends to January 1, 2011,  
               the sunset on the existing exception for any medical  
               experimental treatment that benefits a patient subject to a  
               life-threatening emergency that is conducted in accordance  
               with prescribed requirements from informed consent  
               provisions of the Act.

             b)   SB 160 (Watson), Chapter 68, Statutes of 1997, exempts  
               any medical experimental treatment that benefits a patient  
               subject to a life-threatening emergency, if specified  
               conditions are met, from the informed consent requirements  
               of the Act until January 1, 2001. 

           6)DOUBLE REFERRAL  .  This bill has been double referred.  Should  


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            this bill pass this committee, it will be referred to the  
            Assembly Judiciary Committee.

           7)SUPPORT  .  The sponsor of this bill, the California Chapter of  
            the American College of Emergency Physicians, states that  
            extending the sunset for an exception to informed consent in  
            emergency research is important in ensuring that patients in  
            California with life threatening emergencies caused by trauma  
            or cardiac arrest can continue to take part in clinical trials  
            of treatments that have been shown to have potential for  
            providing direct patient benefit.  Supporters, representing  
            emergency nurses, hospitals, and biomedical researchers, write  
            that unless the sunset date is extended, patients who are  
            unable to give informed consent due to a medical condition  
            will be precluded from receiving what is possibly lifesaving  
            treatment solely because the treatment is experimental and  
            this bill will save lives by ensuring treatment is provided to  
            patients who cannot consent.  The American Heart Association  
            adds in support that research conducted in emergency settings  
            is important to advance knowledge in treating critically ill  
            patients and has helped to improve emergency care for heart  
            disease and stroke patients.     


          American College of Emergency Physicians, California Chapter  
          American Heart Association
          California Emergency Nurses Association
          California Hospital Association
          Los Angeles Biomedical Research Institute
          University of California
          One individual
          None on file.

           Analysis Prepared by  :    Cassie Rafanan / HEALTH / (916)