BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON PUBLIC SAFETY
                             Senator Loni Hancock, Chair
                                2015 - 2016  Regular 

          Bill No:    SB 1238       Hearing Date:    April 19, 2016     
          
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          |Author:    |Pan                                                  |
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          |Version:   |March 29, 2016                                       |
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          |Urgency:   |No                     |Fiscal:    |Yes              |
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          |Consultant:|JRD                                                  |
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                         Subject:  Inmates:  Biomedical Data



          HISTORY

          Source:   California Correctional Healthcare Services 

          Prior Legislation:None known

          Support:  Unknown

          Opposition:None known

           
          PURPOSE

          The purpose of this bill is to permit records-based biomedical  
          research, using existing information, to be conducted on  
          prisoners, notwithstanding a prohibition on biomedical research  
          on prisoners.

          Existing law defines: 

                 "Behavioral research" as studies involving, but not  
               limited to, the investigation of human behavior, emotion,  
               adaptation, conditioning, and response in a program  
               designed to test certain hypotheses through the collection  
               of objective data. Behavioral research does not include the  







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               accumulation of statistical data in the assessment of the  
               effectiveness of programs to which inmates are routinely  
               assigned, such as, but not limited to, education,  
               vocational training, productive work, counseling,  
               recognized therapies, and programs which are not  
               experimental in nature.

                 "Biomedical research" as research relating to or  
               involving biological, medical, or physical science.

                 "Psychotropic drug" as any drug that has the capability  
               of changing or controlling mental functioning or behavior  
               through direct pharmacological action. Such drugs include,  
               but are not limited to, antipsychotic, antianxiety,  
               sedative, antidepressant, and stimulant drugs. Psychotropic  
               drugs also include mind-altering and behavior-altering  
               drugs which, in specified dosages, are used to alleviate  
               certain physical disorders, and drugs which are ordinarily  
               used to alleviate certain physical disorders but may, in  
               specified dosages, have mind-altering or behavior-altering  
               effects.

                 "Research" as a class of activities designed to develop  
               or contribute to generalizable knowledge such as theories,  
               principles, or relationships, or the accumulation of data  
               on which they may be based, that can be corroborated by  
               accepted scientific observation and inferences.

                 "Research protocol" as a formal document setting forth  
               the explicit objectives of a research project and the  
               procedures of investigation designed to reach those  
               objectives.

                 "Phase I drug" as any drug which is designated as a  
               phase I drug for testing purposes under the federal Food  
               and Drug Administration criteria in Section 312.1 of Title  
               21 of the Code of Federal Regulations.

          (Penal Code § 3500.) 


          Existing law provides that the Legislature affirms the  
          fundamental right of competent adults to make decisions about  
          their participation in behavioral research. (Penal Code § 3501.)  








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          Existing law provides that biomedical research shall not be  
          conducted on any prisoner in this state.  (Penal Code § 3502.)

          Existing law provides that notwithstanding Section 3502, any  
          physician who provides medical care to prisoners may provide a  
          patient who is prisoner with a drug or treatment available only  
          through a treatment protocol or treatment IND (investigational  
          new drug) if the physician determines that access to that drug  
          is in the best medical interest of the patient, and the patient  
          has given informed consent.  And, notwithstanding any other  
          provision of law, neither a public
          entity nor a public employee shall be liable for any injury  
          caused by the administration of a drug pursuant, where the  
          administration is made as specified.  (Penal Code § 3502.5.)

          Existing law states that any physical or mental injury of a  
          prisoner resulting from the participation in behavioral  
          research, irrespective of causation of such injury, shall be  
          treated promptly and on a continuing basis until the injury is  
          cured.  (Penal Code § 3504.)

          Existing law requires that behavioral research be limited to  
          studies of the
          possible causes, effects and processes of incarceration and  
          studies of prisons as institutional structures or of prisoners  
          as incarcerated persons which present minimal or no risk and no  
          more than mere inconvenience to the subjects of the research.  
          Informed consent shall not be required for participation in  
          behavioral research when the department determines that it would  
          be unnecessary or significantly inhibit the conduct of such  
          research. In the absence of such determination, informed consent  
          shall be required for participation in behavioral research.  
          (Penal Code § 3505.)

          Existing law requires that behavioral modification techniques  
          shall be used only if such techniques are medically and socially  
          acceptable means by which to modify behavior and if such  
          techniques do not inflict permanent physical or psychological  
          injury. (Penal Code § 3508.)

          This bill permits records-based biomedical research using  
          existing information, without prospective interaction with human  








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          subjects, to be conducted on prisoners, notwithstanding a  
          prohibition on biomedical research on prisoners.

          This bill restricts the use or disclosure of individually  
          identifiable records pursuant to the above provision permitting  
          records-based biomedical research to only occurring after both  
          of the following requirements have been met:

                 The research advisory committee, established pursuant to  
               specified provisions of existing California regulations  
               pertaining to research involving prisoners (currently  
               limited to behavioral research), approves of the use or  
               disclosure; and,
                 The prisoner provides written authorization for the use  
               or disclosure, or the use or disclosure is permitted by  
               specified provisions of federal HIPAA regulations.

          This bill excludes from the definition of "biomedical research,"  
          for purposes of provisions of law governing biomedical and  
          behavioral research of prisoners, the accumulation of  
          statistical data in the assessment of the effectiveness of  
          nonexperimental public health programs or treatment programs in  
          which inmates routinely participate

                    RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION

          For the past several years this Committee has scrutinized  
          legislation referred to its jurisdiction for any potential  
          impact on prison overcrowding.  Mindful of the United States  
          Supreme Court ruling and federal court orders relating to the  
          state's ability to provide a constitutional level of health care  
          to its inmate population and the related issue of prison  
          overcrowding, this Committee has applied its "ROCA" policy as a  
          content-neutral, provisional measure necessary to ensure that  
          the Legislature does not erode progress in reducing prison  
          overcrowding.   

          On February 10, 2014, the federal court ordered California to  
          reduce its in-state adult institution population to 137.5% of  
          design capacity by February 28, 2016, as follows:   

                 143% of design bed capacity by June 30, 2014;
                 141.5% of design bed capacity by February 28, 2015; and,
                 137.5% of design bed capacity by February 28, 2016. 








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          In December of 2015 the administration reported that as "of  
          December 9, 2015, 112,510 inmates were housed in the State's 34  
          adult institutions, which amounts to 136.0% of design bed  
          capacity, and 5,264 inmates were housed in out-of-state  
          facilities.  The current population is 1,212 inmates below the  
          final court-ordered population benchmark of 137.5% of design bed  
          capacity, and has been under that benchmark since February  
          2015."  (Defendants' December 2015 Status Report in Response to  
          February 10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge  
          Court, Coleman v. Brown, Plata v. Brown (fn. omitted).)  One  
          year ago, 115,826 inmates were housed in the State's 34 adult  
          institutions, which amounted to 140.0% of design bed capacity,  
          and 8,864 inmates were housed in out-of-state facilities.   
          (Defendants' December 2014 Status Report in Response to February  
          10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge Court, Coleman  
          v. Brown, Plata v. Brown (fn. omitted).)  
           
          While significant gains have been made in reducing the prison  
          population, the state must stabilize these advances and  
          demonstrate to the federal court that California has in place  
          the "durable solution" to prison overcrowding "consistently  
          demanded" by the court.  (Opinion Re: Order Granting in Part and  
          Denying in Part Defendants' Request For Extension of December  
          31, 2013 Deadline, NO. 2:90-cv-0520 LKK DAD (PC), 3-Judge Court,  
          Coleman v. Brown, Plata v. Brown (2-10-14).  The Committee's  
          consideration of bills that may impact the prison population  
          therefore will be informed by the following questions:

              Whether a proposal erodes a measure which has contributed  
               to reducing the prison population;
              Whether a proposal addresses a major area of public safety  
               or criminal activity for which there is no other  
               reasonable, appropriate remedy;
              Whether a proposal addresses a crime which is directly  
               dangerous to the physical safety of others for which there  
               is no other reasonably appropriate sanction; 
              Whether a proposal corrects a constitutional problem or  
               legislative drafting error; and
              Whether a proposal proposes penalties which are  
               proportionate, and cannot be achieved through any other  
               reasonably appropriate remedy.










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          COMMENTS

          1.  Need for This Bill 

          According to the author: 

               Ten years ago, federal court placed the state's prison  
               health care system under a receivership after  
               determining that an average of one inmate per week  
               died as a result of medical malpractice or neglect.  
               The receivership has improved healthcare in prisons  
               over the last ten years, but the inability to share  
               data-backed best practices contributes to the  
               challenge of providing quality health care to 127,000  
               inmates-who are disproportionately Black and Latino.   
               SB 1238 would authorize the publication of statistical  
               data in the assessment of the effectiveness of  
               nonexperimental public health programs or treatment  
               programs in which inmates routinely participate. This  
               would enable health care providers in prisons and  
               jails to learn from the best practices used at state  
               correctional facilities, and utilize these life-saving  
               techniques.   

               In August of 2015, microscopic bacteria contaminated  
               the water supply of San Quentin State Prison (SQ). A  
               physician working in the prison noticed an unusual  
               number of inmate-patients with pneumonia. Two hours  
               into a collaborative email chain, the healthcare  
               providers of SQ identified the cause of the pneumonia  
               increase: Legionnaires' disease. Data sharing among  
               the heath care staff enabled the California  
               Correctional Health Care Services (CCHCS) and the  
               California Department of Corrections and  
               Rehabilitation to respond to the potential health  
               crisis immediately. The quick identification and  
               effective treatment of the disease prevented the  
               crisis from turning fatal. Data sharing enabled this  
               life-saving response.  The ability to publish some of  
               this data would allow other health care agencies to  
               learn to better manage similar health crises.   
               Nonexperimental medical data can be used to save lives  
               while completely avoiding the ethical dilemmas of  
               allowing experimental biomedical research in prisons.   








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               California's prison system has been on the cutting  
               edge of providing health care to prison inmates, but  
               current law prevents the publishing of  
               non-experimental medical data that could be used to  
               improve health care in correctional facilities and  
               potentially save lives. Prisons face unique health  
               care challenges, and SB 1238 would allow health care  
               providers to share and learn from non-experimental  
               data in order to provide higher quality health care.    


          2.  California Department of Corrections Healthcare:  Federal  
          Receivership

          CCHCS (federal receivership) was established as a result of a  
          class action lawsuit (Plata v. Brown) brought against the State  
          of California over the quality of medical care in the state's 34  
          adult prisons. In its ruling, the federal court found that the  
          care was in violation of the Eighth Amendment of the U.S.  
          Constitution which prohibits cruel and unusual punishment. The  
          state settled the lawsuit and entered into a stipulated  
          settlement in 2002, agreeing to a range of remedies that would  
          bring prison medical care in line with constitutional standards.  
          The state failed to comply with the stipulated settlement and on  
          February 14, 2006, the federal court appointed a receiver to  
          manage medical care operations in the prison system. The current  
          receiver was appointed in January of 2008. The receivership  
          continues to be unprecedented in size and scope nationwide. 

          CCHCS is the sponsor of this legislation and states in support: 

               Over the last several years, the prison system has  
               been the site of extremely newsworthy medical  
               developments, and has been on the cutting edge of  
               providing treatment to prison inmates that would be  
               beneficial to share with the medical community at  
               large. Between 2012 and 2014, the prison system  
               experienced hunger strikes that lasted for a  
               significant period of time. As a result, prison  
               doctors developed an effective monitoring system that  
               provided appropriate treatment as needed during the  
               strikes. Additionally, for the past several years, the  








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               prison system has undertaken a massive program for  
               identifying and treating Valley Fever in our central  
               valley prisons: California was the first health care  
               system in the nation to use a newly developed skin  
               test that identifies exposure/non-exposure to Valley  
               Fever which is now used in making wise housing choices  
               for inmates statewide. Finally, just recently the  
               prison system had an outbreak of Legionnaires Disease  
               at San Quentin (SQ) State Prison where, due to quick  
               identification and effective treatment, doctors were  
               able to successfully treat inmates at SQ without the  
               loss of life. 


               California Correctional Health Care Services, which  
               oversees prison medical care, would like to publish  
               our findings in medical journals that would be of  
               benefit to other correctional and community entities.  
               However, under current law (added in the 1970s) there  
               currently is a prohibition in the California Penal  
               Code for performing or undertaking biomedical research  
               on prisoners Unfortunately, the broad nature of the  
               current statute would even prohibit CCHCS from  
               publishing an accumulation of statistical data that  
               provided an assessment of the effectiveness of any  
               non-experimental public health or treatment program  
               such as described above. 


               This bill would narrowly amend the Penal Code to allow  
               CCHCS to publish findings from non-experimental public  
               health or treatment programs.
          




          3.  Effect of This Legislation 

          This bill provides for the use of statistical data from health  
          treatment programs within prisons in order to publish studies or  
          reports on the efficacy of these health treatment programs.  
          Specifically, this bill excludes from the definition of  
          "biomedical research," and therefore exempts from the ban on  








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          this research, the "accumulation of statistical data" in the  
          assessment of treatment programs in which inmates routinely  
          participated.  This bill, additionally, authorizes biomedical  
          research, but only when it is records-based, using existing  
          information, and does not include prospective interaction with  
          prisoners.  In this provision, the use or disclosure of  
          individually identifiable records is permitted, either with the  
          written authorization of the prisoner, or when the use or  
          disclosure is otherwise permitted under specified federal  
          privacy regulations that permit disclosure without written  
          authorization under certain circumstances. 
           

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