A05065 Summary:

BILL NO    A05065 

SAME AS    No same as 

SPONSOR    Wright

COSPNSR    

MLTSPNSR   

Amd SS2441, 2442, 2444 & 2445, add SS2447 - 2452, Pub Health L

Regulates the use of human subjects for medical research and experimentation,
including subjects with mental disorders and children; makes definitions;
addresses exclusion or inclusion of subjects to participate in human research
based on race, ethnicity or sex; requires reporting certain information
relating to the collection of data; provides that no greater than minimal risk
non-therapeutic human research shall be conducted on a child without consent of
a parent or guardian; makes related provisions.
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A05065 Actions:

BILL NO    A05065 

02/11/2011 referred to health
01/04/2012 referred to health
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A05065 Text:

                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________

                                         5065

                              2011-2012 Regular Sessions

                                 I N  A S S E M B L Y

                                   February 11, 2011
                                      ___________

       Introduced by M. of A. WRIGHT -- read once and referred to the Committee
         on Health

       AN ACT to amend the public health law, in relation to human research

         THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
       BLY, DO ENACT AS FOLLOWS:

    1    Section 1. Section 2441 of the public health law is amended by  adding
    2  ten  new  subdivisions 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 to read as
    3  follows:
    4    7. "MINIMAL RISK" MEANS THE RISKS OF HARM ANTICIPATED IN THE  PROPOSED
    5  HUMAN  RESEARCH  ARE NOT GREATER, CONSIDERING PROBABILITY AND MAGNITUDE,
    6  THAN THOSE ORDINARILY ENCOUNTERED IN DAILY LIFE OR DURING  THE  PERFORM-
    7  ANCE OF ROUTINE PHYSICAL OR PSYCHOLOGICAL EXAMINATIONS OR TESTS.
    8    8.  "GREATER  THAN  MINIMAL  RISK" MEANS THAT THE RISKS OF HARM ANTIC-
    9  IPATED IN THE PROPOSED HUMAN RESEARCH EXCEED THE RISKS OF  HARM  ASSOCI-
   10  ATED WITH MINIMAL RISK HUMAN RESEARCH.
   11    9.  "POSSIBLY  THERAPEUTIC  HUMAN  RESEARCH" IS HUMAN RESEARCH WHICH A
   12  HUMAN RESEARCH REVIEW COMMITTEE HAS DETERMINED HOLDS OUT A  PROSPECT  OF
   13  DIRECT  BENEFIT  AND  IS  IMPORTANT  TO  THE HEALTH OR WELL BEING OF THE
   14  PATIENT AND IS ONLY AVAILABLE IN THE CONTEXT OF THE HUMAN RESEARCH TO BE
   15  CONDUCTED.
   16    10. "NON-THERAPEUTIC HUMAN RESEARCH" IS ALL HUMAN  RESEARCH  WHICH  IS
   17  NOT POSSIBLY THERAPEUTIC HUMAN RESEARCH.
   18    11.  "MENTAL  DISORDER THAT MAY AFFECT DECISION MAKING CAPACITY" MEANS
   19  ANY DISORDER THAT ALTERS MENTAL ACTIVITY, INCLUDING BUT NOT LIMITED  TO,
   20  MENTAL  RETARDATION,  DEMENTIA, BIPOLAR DISORDER, SUBSTANCE ABUSE DISOR-
   21  DER, AND ANY OTHER CONDITION OR BEHAVIOR THAT CALLS A PERSON'S  DECISION
   22  MAKING CAPACITY INTO QUESTION.
   23    12.  "RESEARCH  ADVANCE  DIRECTIVE" MEANS A WRITTEN ADVANCE DIRECTIVE,
   24  EXECUTED BY AN INDIVIDUAL WITH THE CAPACITY TO  DO  SO,  THAT  STATES  A
   25  DESIRE  OF  THE  INDIVIDUAL  TO  PARTICIPATE  IN  RESEARCH  IN  SPECIFIC
   26  RISK/BENEFIT CATEGORIES.
   27    13. "RESEARCH AGENT" MEANS A LEGALLY AUTHORIZED REPRESENTATIVE TO WHOM
   28  AUTHORITY TO MAKE RESEARCH  DECISIONS  IS  DELEGATED  UNDER  A  RESEARCH

        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD03574-01-1
       A. 5065                             2

    1  ADVANCE  DIRECTIVE  EXPRESSLY  AUTHORIZING  PARTICIPATION IN RESEARCH IN
    2  SPECIFIC RISK/BENEFIT CATEGORIES.
    3    14.  "ASSENT"  MEANS AFFIRMATIVE AGREEMENT TO PARTICIPATE IN RESEARCH.
    4  MERE FAILURE TO OBJECT DOES NOT CONSTITUTE ASSENT.
    5    15. "ADULT" MEANS (A) A PERSON OVER THE AGE OF EIGHTEEN YEARS AND  (B)
    6  A  PERSON  UNDER  THE  AGE OF EIGHTEEN YEARS WHO IS (I) IN A PSYCHIATRIC
    7  FACILITY ON VOLUNTARY STATUS ON HIS OR HER OWN APPLICATION, (II) MARRIED
    8  OR (III) THE PARENT OF A CHILD.
    9    16. "CHILD" MEANS A PERSON UNDER THE AGE OF EIGHTEEN  WHO  IS  NOT  AN
   10  ADULT AS DEFINED HEREIN.
   11    S 2. Section 2442 of the public health law, as added by chapter 450 of
   12  the laws of 1975, is amended to read as follows:
   13    S  2442.  Informed consent.   1. No human research may be conducted in
   14  this state in the absence of the voluntary informed  consent  subscribed
   15  to  in  writing  by  the human subject. If the human subject be a minor,
   16  such consent shall be subscribed to in writing by the minor's parent  or
   17  legal  guardian.  If  the  human  subject be otherwise legally unable to
   18  render consent, such consent shall be subscribed to in writing  by  such
   19  other  person  as may be legally empowered to act on behalf of the human
   20  subject. No such voluntary informed consent shall include  any  language
   21  through  which the human subject waives, or appears to waive, any of his
   22  OR HER legal rights, including any release of any  individual,  institu-
   23  tion or agency, or any agents thereof, from liability for negligence.
   24    2.  ANY  ADULT  PERSON  WHO  IS DETERMINED TO LACK CAPACITY TO PROVIDE
   25  VOLUNTARY INFORMED CONSENT TO HUMAN RESEARCH SHALL BE  INFORMED  OF  THE
   26  FOLLOWING  IF  IT IS PROPOSED TO NEVERTHELESS USE SUCH PERSON AS A HUMAN
   27  SUBJECT: (A) THAT HE OR SHE HAS BEEN FOUND TO LACK CAPACITY  TO  MAKE  A
   28  DECISION REGARDING THE RESEARCH; (B) OF THE RIGHT TO OBJECT TO ANY HUMAN
   29  RESEARCH  HE OR SHE MAY BE PLACED IN; (C) OF THE RIGHT TO APPEAL A FIND-
   30  ING OF AN INCAPACITY TO MAKE A DECISION;  (D)  OF  THE  AVAILABILITY  OF
   31  LEGAL  COUNSEL TO ASSIST  IN APPEALING A FINDING OF SUCH INCAPACITY; (E)
   32  WHETHER THE PROPOSED HUMAN RESEARCH IS POSSIBLY THERAPEUTIC OR NON-THER-
   33  APEUTIC; (F) THE INFORMATION DESCRIBED IN SUBDIVISION  FIVE  OF  SECTION
   34  TWENTY-FOUR  HUNDRED  FORTY-ONE OF THIS ARTICLE; (G) THE IDENTITY OF THE
   35  PERSON WHO IS PROPOSED TO ACT AS A SURROGATE DECISION MAKER; AND (H) THE
   36  AVAILABILITY OF LEGAL COUNSEL TO CHALLENGE THE IDENTITY OF THE SURROGATE
   37  DECISION MAKER.
   38    S 3. Section 2444 of the public health law, as added by chapter 450 of
   39  the laws of 1975, is amended to read as follows:
   40    S 2444. Human research review committees.  1. Each public  or  private
   41  institution  or  agency  which conducts, or which proposes to conduct or
   42  authorize, human research,  shall  establish  a  human  research  review
   43  committee.  Such  committee  shall  be  composed  of  not less than five
   44  persons, approved by the commissioner, who have such varied  backgrounds
   45  as  to  assure  the competent, complete and professional review of human
   46  research activities conducted or proposed to be conducted or  authorized
   47  by the institution or agency. No member of a committee shall be involved
   48  in either the initial or continuing review of an activity in which he OR
   49  SHE  has  a conflicting interest, except to provide information required
   50  by the committee. No committee shall consist entirely of persons who are
   51  officers, employees, or agents of, or who are otherwise associated  with
   52  the institution or agency, apart from their membership on the committee,
   53  and  no  committee shall consist entirely of members of a single profes-
   54  sional group.  WHEN THE HUMAN RESEARCH REVIEW  COMMITTEE  REVIEWS  HUMAN
   55  RESEARCH  INVOLVING SUBJECTS WITH MENTAL DISORDERS THAT MAY AFFECT DECI-
   56  SION MAKING CAPACITY, FIFTEEN PERCENT OF THE COMMITTEE MEMBERS,  BUT  NO
       A. 5065                             3

    1  LESS  THAN ONE MEMBER, MUST BE A PERSON WITH SUCH A DISORDER OR A FAMILY
    2  MEMBER OF SUCH PERSON, OR A REPRESENTATIVE OF AN  ADVOCACY  ORGANIZATION
    3  CONCERNED  WITH  THE  WELFARE  OF  SUCH PERSONS. WHEN THE HUMAN RESEARCH
    4  REVIEW  COMMITTEE REVIEWS HUMAN RESEARCH IN WHICH RACE, ETHNICITY OR SEX
    5  IS PROPOSED TO BE A FACTOR AFFECTING EITHER INCLUSION OR EXCLUSION  FROM
    6  HUMAN  RESEARCH,  AT LEAST FIFTEEN PERCENT OF THE COMMITTEE MEMBERS, BUT
    7  NO LESS THAN ONE, MUST BE A MEMBER OF THE RACE, ETHNICITY OR  SEX  WHICH
    8  IS PROPOSED TO BE INCLUDED OR EXCLUDED.
    9    2.  The  human research review committee in each institution or agency
   10  shall require that institution or agency to promulgate  a  statement  of
   11  principle  and  policy  in  regard  to  the  rights and welfare of human
   12  subjects in the conduct of human research, and  the  committee  and  the
   13  commissioner  shall  approve  that statement prior to its taking effect.
   14  The committee shall review  each  proposed  human  research  project  to
   15  determine  (1)  its  necessity;  (2)  that the rights and welfare of the
   16  human subjects involved are adequately protected, (3) that the risks  to
   17  the  human  subjects are outweighed by the potential benefits to them or
   18  by the importance of the knowledge to be gained; (4) that the  voluntary
   19  informed  consent  is  to  be  obtained by methods that are adequate and
   20  appropriate, and (5) that the persons proposed to conduct the particular
   21  medical research are appropriately competent and qualified. The  commit-
   22  tee shall periodically examine each existing human research project with
   23  regard to the proper application of the approved principles and policies
   24  which  the  institution  or  agency has promulgated. The committee shall
   25  report any violation to the commissioner. In addition to  the  voluntary
   26  informed  consent  of  the proposed human subject as required by section
   27  twenty-four hundred forty-two of this [chapter] ARTICLE, the consent  of
   28  the  committee  and  the commissioner shall be required with relation to
   29  the conduct of human research involving  minors,  [incompetent  persons,
   30  mentally  disabled  persons]  SUBJECTS  WITH  MENTAL  DISORDERS THAT MAY
   31  AFFECT DECISION MAKING CAPACITY and prisoners.  ALL DOCUMENTS RELATED TO
   32  REQUESTS SEEKING THE  CONSENT  OF  THE  COMMISSIONER  TO  CONDUCT  HUMAN
   33  RESEARCH ON MINORS, SUBJECTS WITH MENTAL DISORDERS THAT MAY AFFECT DECI-
   34  SION  MAKING  CAPACITY,  AND PRISONERS, AND THE COMMISSIONER'S RULING ON
   35  SUCH REQUESTS, SHALL BE MADE AVAILABLE TO  THE  PUBLIC  UPON  REASONABLE
   36  REQUEST,  PROVIDED THAT THE COMMISSIONER MAY REDACT PROPRIETARY INFORMA-
   37  TION AND TRADE SECRETS. THE NATURE OF THE RISKS AND THE  NATURE  OF  THE
   38  PROCEDURES WHICH ARE PROPOSED TO BE CONDUCTED SHALL NOT BE CONSIDERED TO
   39  BE PROPRIETARY INFORMATION OR A TRADE SECRET.
   40    3.  Each  person engaged in the conduct of human research or proposing
   41  to conduct human research shall affiliate himself  OR  HERSELF  with  an
   42  institution or agency having a human research review committee, and such
   43  human  research  as  he  OR SHE conducts or proposes to conduct shall be
   44  subject to review by such committee in the  manner  set  forth  in  this
   45  section.
   46    4.  NO INSTITUTION OR AGENCY SHALL RETALIATE AGAINST ANY MEMBER OF ITS
   47  HUMAN RESEARCH REVIEW COMMITTEE FOR ANY ACTION TAKEN  BY  THE  COMMITTEE
   48  MEMBER  IN CONNECTION WITH HIS OR HER WORK ON THE COMMITTEE WHICH MAY OR
   49  MAY NOT HAVE HAD ADVERSE EFFECTS ON THE RESEARCH ENTITY AND ANY  OF  ITS
   50  PROTOCOLS.  ANY SUCH AGGRIEVED PERSON MAY COMMENCE AN ACTION PURSUANT TO
   51  THE PROVISIONS OF THIS ARTICLE AS IF SUCH AGGRIEVED PERSON WERE A  HUMAN
   52  SUBJECT FOR THE PURPOSES OF COMMENCING SUCH AN ACTION.
   53    S 4. Section 2445 of the public health law, as added by chapter 450 of
   54  the laws of 1975, is amended to read as follows:
   55    S  2445.  Applicability.    The provisions of this article shall [not]
   56  apply to the conduct of human research [which is subject to,  and  which
       A. 5065                             4

    1  is in compliance with, policies and regulations promulgated by any agen-
    2  cy  of  the  federal  government  for  the protection of human subjects]
    3  CONDUCTED WITHIN THE STATE OF NEW YORK.
    4    S 5. The public health law is amended by adding six new sections 2447,
    5  2448, 2449, 2450, 2451 and 2452 to read as follows:
    6    S  2447.  EXCLUSION  OR  INCLUSION OF SUBJECTS TO PARTICIPATE IN HUMAN
    7  RESEARCH BASED ON RACE, ETHNICITY OR SEX. 1. WHEN RACE, ETHNICITY OR SEX
    8  IS PROPOSED TO BE A FACTOR AFFECTING EITHER INCLUSION OR EXCLUSION  FROM
    9  HUMAN  RESEARCH,  THE  ENTITY  PROPOSING SUCH RESEARCH PROTOCOL SHALL BE
   10  PROVIDED TO THE COMMISSIONER, WITH SPECIFICITY,  THE  CRITERIA  AND  THE
   11  REASONS  WHY  IT IS NECESSARY TO INCLUDE OR EXCLUDE MEMBERS OF A PARTIC-
   12  ULAR RACE, ETHNIC OR SEXUAL POPULATION, WHICH SHALL INCLUDE THE GOALS OF
   13  SUCH RESEARCH.
   14    2. NO SUCH HUMAN RESEARCH SHALL BE CONDUCTED UNLESS IT IS DEMONSTRATED
   15  THAT SUCH RESEARCH IS NECESSARY AND  THAT  SUCH  RESEARCH  IS  THE  ONLY
   16  MANNER  BY  WHICH  THE  SOUGHT  AFTER INFORMATION MAY BE OBTAINED.   THE
   17  APPROVAL OF THE COMMISSIONER SHALL ONLY BE GRANTED UPON  THE  SUBMISSION
   18  OF  SUCH  PROOF. ALL REQUESTS PRESENTED TO THE COMMISSIONER SEEKING SUCH
   19  APPROVAL SHALL BE PUBLISHED IN THE STATE REGISTER SIXTY  DAYS  PRIOR  TO
   20  THE COMMISSIONER MAKING A DECISION ABOUT SUCH REQUEST.
   21    3. THIS SECTION WILL NOT APPLY TO ANY HUMAN RESEARCH WHICH ATTEMPTS TO
   22  ENROLL  SUBJECTS BASED ON RACE, ETHNICITY OR SEX WHEN SUCH ENROLLMENT IS
   23  AN ATTEMPT TO PRODUCE  THE  NUMERICAL  REPRESENTATION  OF  THESE  RACES,
   24  ETHNICITIES  OR SEXES IN THE GENERAL POPULATION OF THIS STATE IN PARTIC-
   25  ULAR OR THE UNITED STATES IN GENERAL.
   26    S 2448. COLLECTION OF DATA. ON THE FIRST BUSINESS DAY OF MARCH, ON  AN
   27  ANNUAL BASIS, ALL ENTITIES CONDUCTING HUMAN RESEARCH SHALL FILE WITH THE
   28  COMMISSIONER  THE  FOLLOWING  INFORMATION RELATIVE TO ALL HUMAN RESEARCH
   29  CONDUCTED IN THIS STATE IN THE IMMEDIATELY PRECEDING CALENDAR YEAR:
   30    1. AN ABSTRACT OF EACH HUMAN RESEARCH PROTOCOL WHICH SHALL  INCLUDE  A
   31  DESCRIPTION  OF  THE  HYPOTHESIS  OF  THE RESEARCH, THE VARIOUS RESEARCH
   32  PROCEDURES UTILIZED AND THE RISKS AND BENEFITS WHICH WERE  PRESENTED  BY
   33  SUCH RESEARCH PROCEDURES TO THE HUMAN RESEARCH SUBJECTS EXPOSED THERETO;
   34    2.  THE  NUMBER OF SUBJECTS WHICH WERE INVOLVED IN EACH HUMAN RESEARCH
   35  PROTOCOL;
   36    3. AN ITEMIZATION OF THE NUMBER OF SUBJECTS  INVOLVED  IN  EACH  HUMAN
   37  RESEARCH  PROTOCOL BY RACE, ETHNICITY, AGE, SEX, CAPACITY TO CONSENT AND
   38  MENTAL DISORDER AND A STATEMENT OF HOW SUCH CONSENT  WAS  OBTAINED  WHEN
   39  SUCH MENTAL DISORDER IS EXTANT WHICH SHALL BE SUPPORTED BY A COPY OF THE
   40  RELEVANT CONSENT FORM;
   41    4.  A  STATEMENT  AS  TO  WHETHER  THE HUMAN RESEARCH REVIEW COMMITTEE
   42  CONSIDER SUCH HUMAN RESEARCH TO BE NON-THERAPEUTIC OR POSSIBLY THERAPEU-
   43  TIC;
   44    5. A STATEMENT AS TO  WHETHER  THE  HUMAN  RESEARCH  REVIEW  COMMITTEE
   45  CONSIDERED  SUCH  HUMAN RESEARCH TO PRESENT MINIMAL RISK OR GREATER THAN
   46  MINIMAL RISK;
   47    6. A DESCRIPTION OF THE TYPE  OF  DISEASES,  ILLNESSES,  SYMPTOMS  AND
   48  CONDITIONS WHICH WERE STUDIED IN EACH SUCH RESEARCH PROTOCOL; AND
   49    7.  A  REPORT  OF  ANY  UNUSUAL INCIDENTS OR NEGATIVE IMPACTS, IF ANY,
   50  SUFFERED BY THE HUMAN SUBJECTS AS A RESULT OF SUCH RESEARCH.
   51    FAILURE TO FILE THIS INFORMATION ON THE REQUIRED DATE, SHALL RESULT IN
   52  THE IMMEDIATE DISCONTINUANCE OF ALL HUMAN RESEARCH FOR WHICH SUCH INFOR-
   53  MATION WAS NOT PROVIDED, IN A MANNER THAT SAFEGUARDS THE WELL  BEING  OF
   54  THE SUBJECTS. FURTHERMORE, THE COMMISSIONER SHALL HALT FURTHER CONSIDER-
   55  ATION  OF  ANY NEW REQUESTS PENDING BEFORE HIM OR HER UNTIL SUCH TIME AS
   56  THE RESEARCH ENTITY IS IN COMPLIANCE.
       A. 5065                             5

    1    ALL SUCH DATA COLLECTED SHALL BE MADE AVAILABLE  TO  THE  PUBLIC  UPON
    2  REASONABLE REQUEST.
    3    S  2449.  DETERMINATION  OF  CAPACITY  TO  PROVIDE INFORMED CONSENT TO
    4  GREATER THAN MINIMAL RISK HUMAN RESEARCH. NO PERSON SHALL BE PRESUMED TO
    5  LACK CAPACITY TO PROVIDE VOLUNTARY INFORMED CONSENT  TO  HUMAN  RESEARCH
    6  SOLELY  BECAUSE  OF  THE  PRESENCE  OF A MENTAL DISORDER THAT MAY AFFECT
    7  DECISION MAKING CAPACITY. HOWEVER, FOR ANY  SUBJECT  WHO  HAS  A  MENTAL
    8  DISORDER  WHICH  MAY AFFECT DECISION MAKING CAPACITY AND FOR ANY SUBJECT
    9  WHO POSSESSES QUESTIONABLE DECISION MAKING CAPACITY, A FINDING  MUST  BE
   10  MADE  AS  TO  WHETHER SUCH SUBJECT HAS THE CAPACITY TO PROVIDE VOLUNTARY
   11  INFORMED CONSENT, AND, IF NOT, WHETHER SUCH SUBJECT HAS THE CAPACITY  TO
   12  ASSENT.
   13    SUCH  A DETERMINATION OF CAPACITY IS A CONDITION WHICH MUST BE MET AND
   14  MADE BY A BOARD CERTIFIED PSYCHIATRIST WHO IS INDEPENDENT OF  THE  HUMAN
   15  RESEARCH ENTITY AND NOT EMPLOYED BY THE INSTITUTION CONDUCTING, SPONSOR-
   16  ING  OR HOUSING SUCH RESEARCH, PRIOR TO THE SUBJECT PARTICIPATING IN ANY
   17  HUMAN RESEARCH.
   18    S 2450. PERMISSIBLE HUMAN RESEARCH ON CHILDREN AND  PERSONS  WHO  LACK
   19  CAPACITY  TO  PROVIDE  VOLUNTARY  INFORMED CONSENT.   1. NO GREATER THAN
   20  MINIMAL RISK, NON-THERAPEUTIC HUMAN RESEARCH SHALL  BE  CONDUCTED  ON  A
   21  CHILD. HOWEVER, A CHILD MAY PARTICIPATE IN POSSIBLY THERAPEUTIC, MINIMAL
   22  RISK  AND POSSIBLE THERAPEUTIC, GREATER THAN MINIMAL RISK HUMAN RESEARCH
   23  IF THE PARENT OR LEGAL GUARDIAN HAS PROVIDED VOLUNTARY INFORMED CONSENT.
   24    2. EXCEPT AS OTHERWISE PROVIDED IN THIS SECTION, NO GREATER THAN MINI-
   25  MAL RISK, NON-THERAPEUTIC HUMAN RESEARCH SHALL BE  CONDUCTED  ON  ADULTS
   26  WHO  LACK  CAPACITY  TO PROVIDE VOLUNTARY INFORMED CONSENT TO SUCH HUMAN
   27  RESEARCH.
   28    3. AN ADULT WHO LACKS CAPACITY TO PROVIDE VOLUNTARY  INFORMED  CONSENT
   29  MAY  BECOME  A  SUBJECT  OF  GREATER  THAN MINIMAL RISK, NON-THERAPEUTIC
   30  RESEARCH PROVIDED THAT: (A) SUCH ADULT PROVIDED SUCH VOLUNTARY  INFORMED
   31  CONSENT  PRIOR  TO  SUCH  INCAPACITY  HAVING  DEVELOPED BY DESIGNATING A
   32  RESEARCH AGENT AND EXECUTING  A  RESEARCH  ADVANCE  DIRECTIVE;  (B)  THE
   33  RESEARCH  IS  EXPECTED TO YIELD GENERALIZABLE KNOWLEDGE IMPORTANT TO THE
   34  UNDERSTANDING OR AMELIORATION OF THE SUBJECT'S  DISORDER  OR  CONDITION;
   35  (C)  THE  KNOWLEDGE CANNOT BE OBTAINED WITHOUT HIS OR HER PARTICIPATION;
   36  AND (D) THE SUBJECT ASSENTS, UNLESS THE INDIVIDUAL HAS  BEEN  DETERMINED
   37  TO LACK CAPACITY TO ASSENT.
   38    4.  NO  POSSIBLE THERAPEUTIC, GREATER THAN MINIMAL RISK HUMAN RESEARCH
   39  SHALL BE CONDUCTED ON AN ADULT WHO LACKS CAPACITY TO  PROVIDE  VOLUNTARY
   40  INFORMED  CONSENT  TO HUMAN RESEARCH: (A) WITHOUT THE VOLUNTARY INFORMED
   41  CONSENT OF THE GUARDIAN OR COMMITTEE OF THE SUBJECT WHO IS AUTHORIZED TO
   42  (I) CONSENT TO POSSIBLY THERAPEUTIC RESEARCH; (II) MONITOR SUCH RESEARCH
   43  AND (III) WITHDRAW THE CONSENT AND REMOVE  THE  SUBJECT  FROM  CONTINUED
   44  PARTICIPATION  IN  THE  RESEARCH  IF  IT IS DETERMINED THAT SUCH FURTHER
   45  PARTICIPATION IS NOT IN THE SUBJECT'S INTEREST; OR (B) WITHOUT  A  COURT
   46  ORDER  UPON  A FINDING BY SUCH COURT THAT THE SUBJECT LACKS THE CAPACITY
   47  TO PROVIDE VOLUNTARY INFORMED CONSENT  AND  THAT  PARTICIPATION  BY  THE
   48  SUBJECT IN SUCH HUMAN RESEARCH IS DETERMINED TO BE IN THE SUBJECT'S BEST
   49  INTEREST.
   50    IN  MAKING A DETERMINATION OF THE SUBJECT'S BEST INTEREST, THE FOLLOW-
   51  ING CRITERIA SHALL BE CONSIDERED: (I) THE RISKS AND  POTENTIAL  BENEFITS
   52  OF  THE  HUMAN  RESEARCH;  (II)  THE MEDICAL AND SCIENTIFIC ALTERNATIVES
   53  AVAILABLE TO THE SUBJECT, INCLUDING THE CHOICE NOT TO TREAT  THE  CONDI-
   54  TION;  AND  (III) WHETHER THE HUMAN RESEARCH PROTOCOL IS CONSISTENT WITH
   55  WHAT IS THEN KNOWN ABOUT THE WISHES, BELIEFS AND MORES OF THE SUBJECT.
       A. 5065                             6

    1    5. REGARDLESS OF CAPACITY TO CONSENT, NO ADULT SHALL BE A  SUBJECT  OF
    2  HUMAN  RESEARCH  IF HE OR SHE, AT ANY TIME, OBJECTS TO ACTIVE OR PASSIVE
    3  PARTICIPATION IN SUCH RESEARCH.
    4    6.  REGARDLESS  OF CAPACITY TO CONSENT, NO ADULT SHALL BE A SUBJECT OF
    5  HUMAN RESEARCH WITHOUT BEING FIRST NOTIFIED THAT HE OR SHE IS  TO  BE  A
    6  SUBJECT  OF HUMAN RESEARCH AND WITHOUT BEING FURTHER NOTIFIED THAT HE OR
    7  SHE HAS THE ABSOLUTE AND UNEQUIVOCAL RIGHT TO REFUSE TO  PARTICIPATE  IN
    8  SUCH HUMAN RESEARCH.
    9    S  2451.  MONITORING  HUMAN  RESEARCH. 1. FOR ALL GREATER THAN MINIMAL
   10  RISK RESEARCH ON INDIVIDUALS WITH A MENTAL DISORDER THAT  AFFECTS  DECI-
   11  SION MAKING CAPACITY, THE HUMAN RESEARCH REVIEW COMMITTEE MUST DESIGNATE
   12  A  MEDICALLY  RESPONSIBLE  CLINICIAN  TO EVALUATE WHETHER EACH SUBJECT'S
   13  PARTICIPATION IN RESEARCH IS APPROPRIATE.
   14    2. THE MEDICALLY RESPONSIBLE CLINICIAN  MUST  BE  A  LICENSED  MEDICAL
   15  DOCTOR  SKILLED  AND  KNOWLEDGEABLE  ABOUT  CARING  FOR PERSONS WITH THE
   16  CONDITIONS OR DISEASES PRESENTED BY THE SPECIFIC  STUDY  POPULATION  AND
   17  MUST  BE INDEPENDENT OF THE RESEARCH ENTITY, EXCEPT AS SPECIFIED IN THIS
   18  SUBDIVISION.
   19    FOR POSSIBLE THERAPEUTIC RESEARCH, THE MEDICALLY RESPONSIBLE CLINICIAN
   20  MAY BE THE SUBJECT'S ATTENDING PHYSICIAN OR A MEMBER  OF  THE  SUBJECT'S
   21  TREATMENT TEAM.
   22    3.  THE  DUTIES  OF  THE  MEDICALLY RESPONSIBLE CLINICIAN INCLUDE: (A)
   23  CONFIRMING THAT THE LEVEL OF RISK (MINIMAL RISK OR GREATER THAN  MINIMAL
   24  RISK) AND THE TYPE OF RESEARCH (POSSIBLY THERAPEUTIC OR NON-THERAPEUTIC)
   25  OF  THE  PROPOSED  RESEARCH  IS UNAMBIGUOUSLY AUTHORIZED BY THE RESEARCH
   26  ADVANCE DIRECTIVE, IF ONE EXISTS; (B) ENSURING THAT THE  RESEARCH  AGENT
   27  UNDERSTANDS THE GOALS AND RISKS OF THE RESEARCH, IF A RESEARCH AGENT HAS
   28  BEEN  DESIGNATED;  (C)  ENSURING  THAT  THE  SUBJECT ASSENTS TO RESEARCH
   29  PARTICIPATION, UNLESS THE SUBJECT HAS BEEN DETERMINED TO  LACK  CAPACITY
   30  TO  ASSENT; (D) MONITORING THE SUBJECT FOR POSSIBLE OBJECTION TO CONTIN-
   31  UED PARTICIPATION; AND (E) MONITORING THE SUBJECT TO ENSURE THAT CONTIN-
   32  UED RESEARCH PARTICIPATION WOULD NOT BE  DETRIMENTAL  TO  THE  SUBJECT'S
   33  WELL-BEING, CONSIDERING ALL RELEVANT CIRCUMSTANCES.
   34    S  2452. RESEARCH AGENT AND RESEARCH ADVANCE DIRECTIVE. 1. EVERY ADULT
   35  SHALL BE PRESUMED CAPABLE OF APPOINTING A  RESEARCH  AGENT  UNLESS  SUCH
   36  PERSON  HAS  BEEN  ADJUDGED  BY A COURT TO BE INCAPABLE OF MAKING HEALTH
   37  CARE DECISIONS OR ADJUDGED BY A COURT TO BE INCAPABLE  OF  APPOINTING  A
   38  RESEARCH  AGENT,  OR UNLESS A GUARDIAN HAS BEEN APPOINTED TO MAKE HEALTH
   39  CARE DECISIONS FOR THE ADULT  PURSUANT  TO  ARTICLE  EIGHTY-ONE  OF  THE
   40  MENTAL HYGIENE LAW OR HAS BEEN APPOINTED PURSUANT TO ARTICLE SEVENTEEN-A
   41  OF THE SURROGATE'S COURT PROCEDURE ACT.
   42    (A)  A  RESEARCH  AGENT  IS DESIGNATED BY EXECUTING A RESEARCH ADVANCE
   43  DIRECTIVE WHICH IS SIGNED AND DATED BY THE ADULT IN THE PRESENCE OF  TWO
   44  ADULT WITNESSES WHO SHALL ALSO SIGN THE RESEARCH ADVANCE DIRECTIVE.
   45    (B) THE WITNESSES SHALL STATE IN WRITING:
   46    (I)  THAT  THE  INDIVIDUAL  APPEARED  TO  EXECUTE THE RESEARCH ADVANCE
   47  DIRECTIVE WILLINGLY AND FREE FROM DURESS;
   48    (II) THAT THE INDIVIDUAL APPEARED TO UNDERSTAND THE DIFFERENCES  AMONG
   49  MEDICAL  TREATMENT,  POSSIBLY  THERAPEUTIC  RESEARCH AND NON-THERAPEUTIC
   50  RESEARCH;
   51    (III) THAT THE INDIVIDUAL APPEARED TO BE  ABLE  TO  EXPRESS  A  CHOICE
   52  ABOUT DELEGATING AUTHORITY FOR SPECIFIC RESEARCH PARTICIPATION DECISIONS
   53  TO  THE  NAMED  RESEARCH AGENT, UNDERSTANDING THAT SUCH AUTHORITY MAY BE
   54  REVOKED AT ANY TIME, MAY BE LIMITED TO SPECIFIC RISK-BENEFIT  CATEGORIES
   55  OF  RESEARCH  AND  WOULD  NOT  PREVENT  THE INDIVIDUAL FROM OBJECTING TO
   56  PARTICIPATE IN THE RESEARCH; AND
       A. 5065                             7

    1    (IV) THAT THE INDIVIDUAL APPEARED TO UNDERSTAND THAT HE OR SHE MAY ASK
    2  A COURT TO DESIGNATE A GUARDIAN TO MAKE A DETERMINATION AS TO THE  INDI-
    3  VIDUAL'S PARTICIPATION IN A PARTICULAR RESEARCH STUDY.
    4    2.  FOR  PERSONS  WHO  RESIDE IN A MENTAL HYGIENE FACILITY OPERATED OR
    5  LICENSED BY THE NEW YORK STATE OFFICE OF  MENTAL  HEALTH,  NO  WITNESSES
    6  SHALL BE AFFILIATED WITH THE FACILITY AND, IF THE MENTAL HYGIENE FACILI-
    7  TY  IS  ALSO A HOSPITAL AS DEFINED IN SUBDIVISION TEN OF SECTION 1.03 OF
    8  THE MENTAL HYGIENE LAW, AT  LEAST  ONE  WITNESS  SHALL  BE  A  QUALIFIED
    9  PSYCHIATRIST.
   10    3.  FOR  PERSONS  WHO  RESIDE IN A MENTAL HYGIENE FACILITY OPERATED OR
   11  LICENSED BY THE NEW YORK STATE OFFICE OF MENTAL RETARDATION AND DEVELOP-
   12  MENTAL DISABILITIES, NO WITNESSES SHALL BE AFFILIATED WITH THE FACILITY,
   13  AND AT LEAST ONE WITNESS SHALL BE A PHYSICIAN OR  CLINICAL  PSYCHOLOGIST
   14  WHO  EITHER IS EMPLOYED BY A SCHOOL NAMED IN SECTION 13.17 OF THE MENTAL
   15  HYGIENE LAW OR WHO HAS BEEN EMPLOYED FOR  A  MINIMUM  OF  TWO  YEARS  TO
   16  RENDER CARE AND SERVICE IN A FACILITY OPERATED OR LICENSED BY THE OFFICE
   17  OF  MENTAL  RETARDATION  AND DEVELOPMENTAL DISABILITIES, OR WHO HAS BEEN
   18  APPROVED BY THE COMMISSIONER OF  MENTAL  RETARDATION  AND  DEVELOPMENTAL
   19  DISABILITIES IN ACCORDANCE WITH REGULATIONS APPROVED BY THE COMMISSIONER
   20  WHICH  SHALL  REQUIRE  THAT A PHYSICIAN OR CLINICAL PSYCHOLOGIST POSSESS
   21  SPECIALIZED TRAINING OR THREE YEARS EXPERIENCE IN TREATING DEVELOPMENTAL
   22  DISABILITIES.
   23    4. AN OPERATOR, ADMINISTRATOR,  OR  EMPLOYEE  OF  A  HOSPITAL,  MENTAL
   24  HYGIENE  FACILITY,  OR PSYCHIATRIC UNIT OF A GENERAL HOSPITAL MAY NOT BE
   25  APPOINTED AS A RESEARCH AGENT BY ANY PERSON WHO,  AT  THE  TIME  OF  THE
   26  APPOINTMENT,  IS  A PATIENT OR RESIDENT OF, OR HAS APPLIED FOR ADMISSION
   27  TO, SUCH HOSPITAL, MENTAL HYGIENE FACILITY, OR  PSYCHIATRIC  UNIT  OF  A
   28  GENERAL  HOSPITAL,  UNLESS  THEY  ARE RELATED TO THE PRINCIPAL BY BLOOD,
   29  MARRIAGE OR ADOPTION.
   30    5. THE RESEARCH AGENT'S AUTHORITY SHALL COMMENCE UPON A  DETERMINATION
   31  THAT  THE INDIVIDUAL LACKS CAPACITY TO MAKE RESEARCH PARTICIPATION DECI-
   32  SIONS.
   33    6. RESEARCH ADVANCE DIRECTIVES EXECUTED BY PERSONS DETERMINED TO  LACK
   34  CAPACITY  TO PROVIDE VOLUNTARY INFORMED CONSENT TO RESEARCH BUT, MEETING
   35  THE REQUIREMENTS IN PARAGRAPH (B) OF SUBDIVISION  ONE  OF  THIS  SECTION
   36  SHALL  BE  LIMITED  TO  AUTHORIZING  POSSIBLY  THERAPEUTIC  RESEARCH AND
   37  NON-THERAPEUTIC RESEARCH WHICH DOES NOT POSE MORE THAN MINIMAL RISK.
   38    7. THE RESEARCH ADVANCE DIRECTIVE SHALL:
   39    (A) IDENTIFY THE PRINCIPAL AND THE AGENT;
   40    (B) INDICATE THAT THE PRINCIPAL INTENDS THE AGENT TO HAVE AUTHORITY TO
   41  MAKE RESEARCH PARTICIPATION DECISIONS ON THE PRINCIPAL'S BEHALF;
   42    (C)  SPECIFY  THE  PRINCIPAL'S  INSTRUCTIONS  ABOUT  PARTICIPATION  IN
   43  SPECIFIC RISK-BENEFIT CATEGORIES OR SPECIFIC RESEARCH; AND
   44    (D)  INCLUDE A STATEMENT THAT RESEARCH IS DIFFERENT FROM CLINICAL CARE
   45  IN THAT RESEARCH IS DESIGNED TO GAIN  NEW  INFORMATION  THAT  WILL  HELP
   46  OTHER  PERSONS  IN THE FUTURE AND NOT NECESSARILY THE PARTICIPANT IN THE
   47  RESEARCH AND THAT, FOR SOME RESEARCH, THERE MAY BE NO  EXPECTED  MEDICAL
   48  BENEFIT FOR THE SUBJECT.
   49    8.  AFTER CONSULTATION WITH INTERESTED PERSONS, THE COMMISSIONER SHALL
   50  PREPARE AND DISTRIBUTE A MODEL FORM OF A RESEARCH ADVANCE DIRECTIVE, THE
   51  USE OF WHICH SHALL BE OPTIONAL.
   52    S 6. This act shall take effect on the one hundred twentieth day after
   53  it shall have become a law; provided that the commissioner of health  is
   54  authorized  to promulgate any and all rules and regulations and take any
   55  other measures necessary to implement this act on its effective date  on
   56  or before such effective date.
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