BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE JUDICIARY COMMITTEE
                           Senator Ellen M. Corbett, Chair
                              2009-2010 Regular Session


          SB 1187 (Strickland)
          As Introduced
          Hearing Date: April 27, 2010
          Fiscal: No
          Urgency: No
          KB

                                        SUBJECT
                                           
                                Human Experimentation

                                      DESCRIPTION  

          This bill, sponsored by the California Chapter of the American  
          College of Emergency Physicians, would, until January 1, 2021,  
          extend the exemption in the Protection of Human Subjects in  
          Medical Experimentation Act that authorizes the use of medical  
          experimental treatment without a patient's informed consent if  
          it benefits a patient subject to a life-threatening emergency.  

                                      BACKGROUND  

          In 1996, the U.S. Food and Drug Administration (FDA) and the  
          Department of Health and Human Services created new regulations  
          to permit clinical trials to be conducted where informed consent  
          cannot be obtained from patients facing life-threatening  
          situations.  Those regulations provided a very narrow exception  
          to the requirement of obtaining the informed consent from a  
          patient.  A physician may only infer informed consent where the  
          patient is in critical condition and will deteriorate and pass  
          away without immediate treatment.  These regulations were the  
          result of over two years of public testimony and discussion  
          forums held around the nation.

          In order to comply with these federal regulations, the  
          Legislature enacted SB 160 (Watson, Chapter 68, Statutes of  
          1997), which created an exception to the Protection of Human  
          Subjects in Medical Experimentation Act for medical experimental  
          treatment that benefits a patient subject to a life-threatening  
          emergency, under specified conditions.  SB 160 contained a  
          three-year sunset provision, which expired on January 1, 2001,  
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          in order to monitor the impact of the exception.
           
          In 2001, SB 1188 (Committee on Health and Human Services)  
          extended the exception for another ten years, until January 1,  
          2011 in order to keep state law in compliance with federal  
          regulations.  This bill would extend the sunset for an  
          additional ten years.
                                CHANGES TO EXISTING LAW
           
           Existing federal law  establishes general procedures and  
          protections pertaining to the use of human subjects in medical  
          experimentation.   Existing federal law contains a narrow  
          exception to these general requirements where a patient's  
          informed consent cannot be obtained because he or she is in a  
          life-threatening situation.  (21 CFR 50; 21 CFR 50.23; 45 CFR  
          46.)
           
          Existing law  , the Protection of Human Subjects in Medical  
          Experimentation Act (Act), provides protections for subjects of  
          medical experimentation and penalties for violations of those  
          provisions.  (Health & Saf. Code Sec. 24173.)  These protections  
          include:  

             (1) a bill of rights for subjects of medical experimentation,  
               written in a language in which the subject is fluent; 
            (2) a requirement that a subject receive a copy of the bill of  
            rights; 
             (3) a requirement that the subject give a signed, written,  
               informed consent for the procedures, drugs, or devices that  
               would be applied or taken;
             (4) a requirement for specified disclosures regarding the  
               medical experimentation, including the right to withdraw  
               consent, affiliation, and address of the person or persons  
               conducting the experiment, the name of the sponsor or  
               funding source or manufacturer of the experiment, and the  
               name, address, and phone number of an impartial third party  
               to whom the subject may direct complaints; and
             (5) a right to give consent freely and without force, fraud,  
               duress, or undue influence.

           Existing law  provides an exception from the Act, until January  
          1, 2011, for any medical experimental treatment that benefits a  
          patient subject to a life-threatening emergency if prescribed  
          conditions are met.  (Health & Saf. Code Sec. 24177.5.)   
          Specifically, existing law requires that:  

                                                                      



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             (1)  care must be provided in accordance with the procedures  
               and the additional protections of the rights and welfare of  
               the patient set forth in federal regulations;
             (2)  the patient is in a life-threatening situation  
               necessitating urgent intervention and available treatments  
               are unproven or unsatisfactory;
             (3)  the patient is unable to give informed consent as a  
               result of the patient's medical condition;
             (4)  obtaining informed consent from the patient's legally  
               authorized representatives is not feasible before the  
               treatment must be administered;
             (5)  there is no reasonable way to identify prospectively the  
               individuals likely to become eligible for participation in  
               the clinical investigation; and
             (6)  valid scientific studies have been conducted that  
               support the potential for intervention to provide a direct  
               benefit to the patient.

           This bill  would extend the exception until January 1, 2021.
                                        COMMENT
           
           1.Stated need for the bil  l

          The author states:

            Under existing law, vital research has been conducted to  
            resuscitation from cardiac arrest, stabilizing uncontrolled  
            seizures in children, improving CPR, and controlling bleeding  
            and shock in trauma patients.  This research has helped [to]  
            save lives and provide better emergency care for numerous  
            patients.  

            In 1996, in an effort to allow clinical research in emergency  
            settings when informed consent is not feasible while  
            simultaneously protecting rights of the patients, the  
            Department of Health and Human Services and the Food and Drug  
            Administration created stringent guidelines to allow clinical  
            trials when informed consent could not be obtained from  
            patients in life threatening situations.  The federal law  
            imposes additional requirements and patient protections, even  
            beyond those which are mandatory to perform other clinical  
            trials.  

          The author states that this bill would extend the sunset that  
          conforms California law to federal regulations pertaining to the  
          use of medical experimentation for patients in a  
                                                                      



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          life-threatening situation.  The author asserts that critical,  
          live-saving research will cease to continue in California if  
          this law is allowed to sunset.   

          Additionally, the University of California writes in support:

            UC operates medical centers in Davis, Los Angeles, Irvine, San  
            Diego, and San Francisco.  The UC clinical enterprise is the  
            fourth largest healthcare delivery system in the state and  
            staffs five trauma centers throughout California.  On an  
            annual basis, we see approximately 284,000 patients in our  
            emergency department.  The University is also one of the  
            largest recipients of National Institutes of Health (NIH)  
            funding in the nation for cutting edge research.  The  
            provision of complex critical care to California's medically  
            vulnerable population and the undertaking of medical research  
            are two of the key missions of the University of California.   
            SB 1187 would enable us to continue to fulfill our mission to  
            and for the people of California.  

           2.Parameters for clinical trials established by federal  
            regulations
           
          The doctrine of informed consent provides that a patient must be  
          informed of the risks and benefits of proposed medical  
          treatment, and of alternative courses of treatment.  
          In the absence of the patient giving informed consent,  
          unauthorized medical treatment constitutes the tort of battery.   
          In addition, under the Protection of Human Subjects in Medical  
          Experimentation Act (Act), the performance of a medical  
          experiment without a patient's informed consent is punishable by  
          both civil and criminal penalties.  (Health & Saf. Code Sec.  
          24176.)  
          As previously discussed, the 1996 federal regulations carved out  
          a narrow exception to the informed consent requirement in order  
          to facilitate clinical trials of experimental, life-saving  
          treatments in situations where a patient's condition prevents  
          him/her from providing consent.  These federal regulations are  
          still in place, and impose strict parameters, described below,  
          on when experimental treatment may be administered without a  
          patient's informed consent in a clinical trial.  (21 CFR 50.24.)

           Participation in emergency research must hold out the prospect  
          of direct benefit to the individual subject.  The sponsor of the  
          research must use available data to identify the therapeutic  
          window during which the administration of the treatment to the  
                                                                      



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          patient should be initiated.  The therapeutic window will vary  
          from study to study and is generally defined 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 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 arrests, the therapeutic window may be very short.  

          Sponsors of a clinical trial will 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.  Pursuant to 21 CFR 50.24, the IRB must provide  
          an opportunity for community consultation and public disclosure  
          to generally inform the surrounding communities about the  
          proposed clinical trial, its risks, and potential benefits.  The  
          disclosures should also 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 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  
          Web site (available at http://www.fda.gov/ohrms/dockets/  
          /95s0158/95s0158.htm.)  (21 CFR 56.109(g); 21 CFR 812.47(a).)

          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.  (21 CFR 50.24(a)(7)(v).)   
          Furthermore, IRBs must ensure that there are procedures in place  
          to provide information about the clinical trial, at the 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  
                                                                      



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          participation in the clinical trial.

           3.Impact of a Patient's Do Not Resuscitate Form

           A Do Not Resuscitate (DNR) Form is an official State document  
          developed by the California EMS 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 (CPR); assisted ventilation  
          (breathing); defibrillation; and cardiotonic drugs (drugs which  
          stimulate the heart).  The form does not affect the provision of  
          other emergency medical care, including treatment for pain (also  
          known as "comfort measures"), 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 then it should take  
          precedence over the emergency research conducted in a clinical  
          trial.  In other words, a physician would 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 therefore will attempt to  
          resuscitate the patient.  Therefore, pursuant to the exception  
          created by this bill, there may be instances when a patient  
          receives experimental treatment as part of a clinical trial  
          against the patient's wishes to not be resuscitated.  

          This committee may wish to inquire of the author and sponsor  
          whether they are aware of any instances where this has happened  
          and what protocols are followed in cases where a patient has  
          executed a DNR.  
           
          4.Lack of information to support a lengthy sunset
           
          When SB 160 was first enacted it contained a three-year sunset  
          to allow for monitoring of the new exception to informed  
          consent.  However, no reporting requirement was added to the  
          bill along with the sunset, thus it is unclear what information  
          was to be used by or provided to the Legislature for the  
          purposes of monitoring the new exception.  At the end of the  
          three year sunset, SB 1188 was passed as an urgency measure to  
          extend the sunset for the informed consent exception by ten  
          years, also with no reporting requirement.  
                                                                      



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          Committee staff notes that ten years is atypically long for a  
          sunset extension.  Sunsets are usually shorter time periods and  
          are generally accompanied by a reporting requirement so as to  
          enable the Legislature to monitor whether the statute or program  
          is having its intended effect or whether unanticipated  
          consequences have arisen.  With this particular exception to the  
          Protection of Human Subjects in Medical Experimentation Act, no  
          reports were ever mandated (possibly because there is no central  
          repository for this information), nor does it appear that any  
          reports were voluntarily compiled by the hospitals or physicians  
          administering clinical trials under the statute.  

          According to the sponsor, the research and clinical trials  
          utilizing the exception to informed consent have decreased  
          because of the stringent requirements in federal regulations.   
          In particular, many proposals are ultimately rejected by IRBs  
          because the degree of community consultation conducted by the  
          sponsor is not sufficient.  Committee staff notes that the  
          docket on the U.S. Food and Drug Administration contains  
          information on three clinical trials conducted in California  
          between 1997 and 2007 at Glendale Memorial Hospital, UC San  
          Diego, and UCLA.  The sponsor additionally notes that research  
          is currently being conducted by UC San Francisco and UC Davis  
          that focuses on which treatments are more beneficial to children  
          who suffer from seizures.  This information does seem to  
          indicate the clinical trials that utilize the exception to  
          informed consent are not frequently taking place.  

          However, the docket information alone is not enough to permit  
          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 the exact treatments used in each trial,  
          the exact 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 ten  
          years, but there has not been enough information presented to  
          support any conclusion at this point.  

          In light of this lack of information and because of the serious  
          nature of administering medical treatment without a patient's  
          informed consent, this Committee may wish to consider whether a  
          shorter sunset extension, such as three years, is more  
                                                                      



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          appropriate.  This would keep the exception intact to allow for  
          the completion of the trial in progress and would provide the  
          proponents of this measure with additional time to compile the  
          information necessary to demonstrate to the Legislature whether  
          a longer sunset is warranted.  

            Suggested amendment:

            On page 2, line 31, strike "2021" and insert "2014"
            On page 2, line 32, strike "2021" and insert "2014"
           

          Support  :  California Emergency Nurses Association; California  
          Hospital Association; Los Angeles Biomedical Research Institute;  
          University of California; one individual

           Opposition  :  None Known

                                        HISTORY
           
           Source  :  California Chapter of the American College of Emergency  
          Physicians

           Related Pending Legislation  :  None Known

           Prior Legislation  :  See Background

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