S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2409
 
                        2019-2020 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 22, 2019
                                ___________
 
 Introduced  by M. of A. DICKENS -- read once and referred to the Commit-
   tee 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:

   Section  1. Section 2441 of the public health law is amended by adding
 ten new subdivisions 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 to  read  as
 follows:
   7.  "MINIMAL RISK" MEANS THE RISKS OF HARM ANTICIPATED IN THE PROPOSED
 HUMAN RESEARCH  ARE NOT GREATER, CONSIDERING PROBABILITY AND  MAGNITUDE,
 THAN  THOSE  ORDINARILY ENCOUNTERED IN DAILY LIFE OR DURING THE PERFORM-
 ANCE OF ROUTINE PHYSICAL OR PSYCHOLOGICAL EXAMINATIONS OR TESTS.
   8. "GREATER THAN MINIMAL RISK" MEANS THAT THE  RISKS  OF  HARM  ANTIC-
 IPATED  IN  THE PROPOSED HUMAN RESEARCH EXCEED THE RISKS OF HARM ASSOCI-
 ATED WITH MINIMAL RISK HUMAN RESEARCH.
   9. "POSSIBLY THERAPEUTIC HUMAN RESEARCH" IS  HUMAN  RESEARCH  WHICH  A
 HUMAN  RESEARCH  REVIEW COMMITTEE HAS DETERMINED HOLDS OUT A PROSPECT OF
 DIRECT BENEFIT AND IS IMPORTANT TO THE  HEALTH  OR  WELL  BEING  OF  THE
 PATIENT AND IS ONLY AVAILABLE IN THE CONTEXT OF THE HUMAN RESEARCH TO BE
 CONDUCTED.
   10.  "NON-THERAPEUTIC  HUMAN  RESEARCH" IS ALL HUMAN RESEARCH WHICH IS
 NOT POSSIBLY THERAPEUTIC HUMAN RESEARCH.
   11. "MENTAL DISORDER THAT MAY AFFECT DECISION MAKING  CAPACITY"  MEANS
 ANY  DISORDER THAT ALTERS MENTAL ACTIVITY, INCLUDING BUT NOT LIMITED TO,
 MENTAL RETARDATION, DEMENTIA, BIPOLAR DISORDER, SUBSTANCE  ABUSE  DISOR-
 DER,  AND ANY OTHER CONDITION OR BEHAVIOR THAT CALLS A PERSON'S DECISION
 MAKING CAPACITY INTO QUESTION.
   12. "RESEARCH ADVANCE DIRECTIVE" MEANS A  WRITTEN  ADVANCE  DIRECTIVE,
 EXECUTED  BY  AN  INDIVIDUAL  WITH  THE CAPACITY TO DO SO, THAT STATES A
 DESIRE  OF  THE  INDIVIDUAL  TO  PARTICIPATE  IN  RESEARCH  IN  SPECIFIC
 RISK/BENEFIT CATEGORIES.
   13. "RESEARCH AGENT" MEANS A LEGALLY AUTHORIZED REPRESENTATIVE TO WHOM
 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.
                                                            LBD06499-01-9

 A. 2409                             2
 
 ADVANCE DIRECTIVE EXPRESSLY AUTHORIZING  PARTICIPATION  IN  RESEARCH  IN
 SPECIFIC RISK/BENEFIT CATEGORIES.
   14.  "ASSENT"  MEANS AFFIRMATIVE AGREEMENT TO PARTICIPATE IN RESEARCH.
 MERE FAILURE TO OBJECT DOES NOT CONSTITUTE ASSENT.
   15. "ADULT" MEANS (A) A PERSON OVER THE AGE OF EIGHTEEN YEARS AND  (B)
 A  PERSON  UNDER  THE  AGE OF EIGHTEEN YEARS WHO IS (I) IN A PSYCHIATRIC
 FACILITY ON VOLUNTARY STATUS ON HIS OR HER OWN APPLICATION, (II) MARRIED
 OR (III) THE PARENT OF A CHILD.
   16. "CHILD" MEANS A PERSON UNDER THE AGE OF EIGHTEEN  WHO  IS  NOT  AN
 ADULT AS DEFINED HEREIN.
   § 2. Section 2442 of the public health law, as added by chapter 450 of
 the laws of 1975, is amended to read as follows:
   §  2442.  Informed consent.   1. No human research may be conducted in
 this state in the absence of the voluntary informed  consent  subscribed
 to  in  writing  by  the human subject. If the human subject be a minor,
 such consent shall be subscribed to in writing by the minor's parent  or
 legal  guardian.  If  the  human  subject be otherwise legally unable to
 render consent, such consent shall be subscribed to in writing  by  such
 other  person  as may be legally empowered to act on behalf of the human
 subject. No such voluntary informed consent shall include  any  language
 through  which the human subject waives, or appears to waive, any of his
 OR HER legal rights, including any release of any  individual,  institu-
 tion or agency, or any agents thereof, from liability for negligence.
   2.  ANY  ADULT  PERSON  WHO  IS DETERMINED TO LACK CAPACITY TO PROVIDE
 VOLUNTARY INFORMED CONSENT TO HUMAN RESEARCH SHALL BE  INFORMED  OF  THE
 FOLLOWING  IF  IT IS PROPOSED TO NEVERTHELESS USE SUCH PERSON AS A HUMAN
 SUBJECT: (A) THAT HE OR SHE HAS BEEN FOUND TO LACK CAPACITY  TO  MAKE  A
 DECISION REGARDING THE RESEARCH; (B) OF THE RIGHT TO OBJECT TO ANY HUMAN
 RESEARCH  HE OR SHE MAY BE PLACED IN; (C) OF THE RIGHT TO APPEAL A FIND-
 ING OF AN INCAPACITY TO MAKE A DECISION;  (D)  OF  THE  AVAILABILITY  OF
 LEGAL  COUNSEL TO ASSIST  IN APPEALING A FINDING OF SUCH INCAPACITY; (E)
 WHETHER THE PROPOSED HUMAN RESEARCH IS POSSIBLY THERAPEUTIC OR NON-THER-
 APEUTIC; (F) THE INFORMATION DESCRIBED IN SUBDIVISION  FIVE  OF  SECTION
 TWENTY-FOUR  HUNDRED  FORTY-ONE OF THIS ARTICLE; (G) THE IDENTITY OF THE
 PERSON WHO IS PROPOSED TO ACT AS A SURROGATE DECISION MAKER; AND (H) THE
 AVAILABILITY OF LEGAL COUNSEL TO CHALLENGE THE IDENTITY OF THE SURROGATE
 DECISION MAKER.
   § 3. Section 2444 of the public health law, as added by chapter 450 of
 the laws of 1975, is amended to read as follows:
   § 2444. Human research review committees.  1. Each public  or  private
 institution  or  agency  which conducts, or which proposes to conduct or
 authorize, human research,  shall  establish  a  human  research  review
 committee.  Such  committee  shall  be  composed  of  not less than five
 persons, approved by the commissioner, who have such varied  backgrounds
 as  to  assure  the competent, complete and professional review of human
 research activities conducted or proposed to be conducted or  authorized
 by the institution or agency. No member of a committee shall be involved
 in either the initial or continuing review of an activity in which he OR
 SHE  has  a conflicting interest, except to provide information required
 by the committee. No committee shall consist entirely of persons who are
 officers, employees, or agents of, or who are otherwise associated  with
 the institution or agency, apart from their membership on the committee,
 and  no  committee shall consist entirely of members of a single profes-
 sional group.  WHEN THE HUMAN RESEARCH REVIEW  COMMITTEE  REVIEWS  HUMAN
 RESEARCH  INVOLVING SUBJECTS WITH MENTAL DISORDERS THAT MAY AFFECT DECI-
 SION MAKING CAPACITY, FIFTEEN PERCENT OF THE COMMITTEE MEMBERS,  BUT  NO

 A. 2409                             3
 
 LESS  THAN ONE MEMBER, MUST BE A PERSON WITH SUCH A DISORDER OR A FAMILY
 MEMBER OF SUCH PERSON, OR A REPRESENTATIVE OF AN  ADVOCACY  ORGANIZATION
 CONCERNED  WITH  THE  WELFARE  OF  SUCH PERSONS. WHEN THE HUMAN RESEARCH
 REVIEW  COMMITTEE REVIEWS HUMAN RESEARCH IN WHICH RACE, ETHNICITY OR SEX
 IS PROPOSED TO BE A FACTOR AFFECTING EITHER INCLUSION OR EXCLUSION  FROM
 HUMAN  RESEARCH,  AT LEAST FIFTEEN PERCENT OF THE COMMITTEE MEMBERS, BUT
 NO LESS THAN ONE, MUST BE A MEMBER OF THE RACE, ETHNICITY OR  SEX  WHICH
 IS PROPOSED TO BE INCLUDED OR EXCLUDED.
   2.  The  human research review committee in each institution or agency
 shall require that institution or agency to promulgate  a  statement  of
 principle  and  policy  in  regard  to  the  rights and welfare of human
 subjects in the conduct of human research, and  the  committee  and  the
 commissioner  shall  approve  that statement prior to its taking effect.
 The committee shall review  each  proposed  human  research  project  to
 determine  (1)  its  necessity;  (2)  that the rights and welfare of the
 human subjects involved are adequately protected, (3) that the risks  to
 the  human  subjects are outweighed by the potential benefits to them or
 by the importance of the knowledge to be gained; (4) that the  voluntary
 informed  consent  is  to  be  obtained by methods that are adequate and
 appropriate, and (5) that the persons proposed to conduct the particular
 medical research are appropriately competent and qualified. The  commit-
 tee shall periodically examine each existing human research project with
 regard to the proper application of the approved principles and policies
 which  the  institution  or  agency has promulgated. The committee shall
 report any violation to the commissioner. In addition to  the  voluntary
 informed  consent  of  the proposed human subject as required by section
 twenty-four hundred forty-two of this [chapter] ARTICLE, the consent  of
 the  committee  and  the commissioner shall be required with relation to
 the conduct of human research involving  minors,  [incompetent  persons,
 mentally  disabled  persons]  SUBJECTS  WITH  MENTAL  DISORDERS THAT MAY
 AFFECT DECISION MAKING CAPACITY and prisoners.  ALL DOCUMENTS RELATED TO
 REQUESTS SEEKING THE  CONSENT  OF  THE  COMMISSIONER  TO  CONDUCT  HUMAN
 RESEARCH ON MINORS, SUBJECTS WITH MENTAL DISORDERS THAT MAY AFFECT DECI-
 SION  MAKING  CAPACITY,  AND PRISONERS, AND THE COMMISSIONER'S RULING ON
 SUCH REQUESTS, SHALL BE MADE AVAILABLE TO  THE  PUBLIC  UPON  REASONABLE
 REQUEST,  PROVIDED THAT THE COMMISSIONER MAY REDACT PROPRIETARY INFORMA-
 TION AND TRADE SECRETS. THE NATURE OF THE RISKS AND THE  NATURE  OF  THE
 PROCEDURES WHICH ARE PROPOSED TO BE CONDUCTED SHALL NOT BE CONSIDERED TO
 BE PROPRIETARY INFORMATION OR A TRADE SECRET.
   3.  Each  person engaged in the conduct of human research or proposing
 to conduct human research shall affiliate himself  OR  HERSELF  with  an
 institution or agency having a human research review committee, and such
 human  research  as  he  OR SHE conducts or proposes to conduct shall be
 subject to review by such committee in the  manner  set  forth  in  this
 section.
   4.  NO INSTITUTION OR AGENCY SHALL RETALIATE AGAINST ANY MEMBER OF ITS
 HUMAN RESEARCH REVIEW COMMITTEE FOR ANY ACTION TAKEN  BY  THE  COMMITTEE
 MEMBER  IN CONNECTION WITH HIS OR HER WORK ON THE COMMITTEE WHICH MAY OR
 MAY NOT HAVE HAD ADVERSE EFFECTS ON THE RESEARCH ENTITY AND ANY  OF  ITS
 PROTOCOLS.  ANY SUCH AGGRIEVED PERSON MAY COMMENCE AN ACTION PURSUANT TO
 THE PROVISIONS OF THIS ARTICLE AS IF SUCH AGGRIEVED PERSON WERE A  HUMAN
 SUBJECT FOR THE PURPOSES OF COMMENCING SUCH AN ACTION.
   § 4. Section 2445 of the public health law, as added by chapter 450 of
 the laws of 1975, is amended to read as follows:
   §  2445.  Applicability.    The provisions of this article shall [not]
 apply to the conduct of human research [which is subject to,  and  which

 A. 2409                             4

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

 A. 2409                             5
 
   ALL SUCH DATA COLLECTED SHALL BE MADE AVAILABLE  TO  THE  PUBLIC  UPON
 REASONABLE REQUEST.
   §  2449.  DETERMINATION  OF  CAPACITY  TO  PROVIDE INFORMED CONSENT TO
 GREATER THAN MINIMAL RISK HUMAN RESEARCH. NO PERSON SHALL BE PRESUMED TO
 LACK CAPACITY TO PROVIDE VOLUNTARY INFORMED CONSENT  TO  HUMAN  RESEARCH
 SOLELY  BECAUSE  OF  THE  PRESENCE  OF A MENTAL DISORDER THAT MAY AFFECT
 DECISION MAKING CAPACITY. HOWEVER, FOR ANY  SUBJECT  WHO  HAS  A  MENTAL
 DISORDER  WHICH  MAY AFFECT DECISION MAKING CAPACITY AND FOR ANY SUBJECT
 WHO POSSESSES QUESTIONABLE DECISION MAKING CAPACITY, A FINDING  MUST  BE
 MADE  AS  TO  WHETHER SUCH SUBJECT HAS THE CAPACITY TO PROVIDE VOLUNTARY
 INFORMED CONSENT, AND, IF NOT, WHETHER SUCH SUBJECT HAS THE CAPACITY  TO
 ASSENT.
   SUCH  A DETERMINATION OF CAPACITY IS A CONDITION WHICH MUST BE MET AND
 MADE BY A BOARD CERTIFIED PSYCHIATRIST WHO IS INDEPENDENT OF  THE  HUMAN
 RESEARCH ENTITY AND NOT EMPLOYED BY THE INSTITUTION CONDUCTING, SPONSOR-
 ING  OR HOUSING SUCH RESEARCH, PRIOR TO THE SUBJECT PARTICIPATING IN ANY
 HUMAN RESEARCH.
   § 2450. PERMISSIBLE HUMAN RESEARCH ON CHILDREN AND  PERSONS  WHO  LACK
 CAPACITY  TO  PROVIDE  VOLUNTARY  INFORMED CONSENT.   1. NO GREATER THAN
 MINIMAL RISK, NON-THERAPEUTIC HUMAN RESEARCH SHALL  BE  CONDUCTED  ON  A
 CHILD. HOWEVER, A CHILD MAY PARTICIPATE IN POSSIBLY THERAPEUTIC, MINIMAL
 RISK  AND POSSIBLE THERAPEUTIC, GREATER THAN MINIMAL RISK HUMAN RESEARCH
 IF THE PARENT OR LEGAL GUARDIAN HAS PROVIDED VOLUNTARY INFORMED CONSENT.
   2. EXCEPT AS OTHERWISE PROVIDED IN THIS SECTION, NO GREATER THAN MINI-
 MAL RISK, NON-THERAPEUTIC HUMAN RESEARCH SHALL BE  CONDUCTED  ON  ADULTS
 WHO  LACK  CAPACITY  TO PROVIDE VOLUNTARY INFORMED CONSENT TO SUCH HUMAN
 RESEARCH.
   3. AN ADULT WHO LACKS CAPACITY TO PROVIDE VOLUNTARY  INFORMED  CONSENT
 MAY  BECOME  A  SUBJECT  OF  GREATER  THAN MINIMAL RISK, NON-THERAPEUTIC
 RESEARCH PROVIDED THAT: (A) SUCH ADULT PROVIDED SUCH VOLUNTARY  INFORMED
 CONSENT  PRIOR  TO  SUCH  INCAPACITY  HAVING  DEVELOPED BY DESIGNATING A
 RESEARCH AGENT AND EXECUTING  A  RESEARCH  ADVANCE  DIRECTIVE;  (B)  THE
 RESEARCH  IS  EXPECTED TO YIELD GENERALIZABLE KNOWLEDGE IMPORTANT TO THE
 UNDERSTANDING OR AMELIORATION OF THE SUBJECT'S  DISORDER  OR  CONDITION;
 (C)  THE  KNOWLEDGE CANNOT BE OBTAINED WITHOUT HIS OR HER PARTICIPATION;
 AND (D) THE SUBJECT ASSENTS, UNLESS THE INDIVIDUAL HAS  BEEN  DETERMINED
 TO LACK CAPACITY TO ASSENT.
   4.  NO  POSSIBLE THERAPEUTIC, GREATER THAN MINIMAL RISK HUMAN RESEARCH
 SHALL BE CONDUCTED ON AN ADULT WHO LACKS CAPACITY TO  PROVIDE  VOLUNTARY
 INFORMED  CONSENT  TO HUMAN RESEARCH: (A) WITHOUT THE VOLUNTARY INFORMED
 CONSENT OF THE GUARDIAN OR COMMITTEE OF THE SUBJECT WHO IS AUTHORIZED TO
 (I) CONSENT TO POSSIBLY THERAPEUTIC RESEARCH; (II) MONITOR SUCH RESEARCH
 AND (III) WITHDRAW THE CONSENT AND REMOVE  THE  SUBJECT  FROM  CONTINUED
 PARTICIPATION  IN  THE  RESEARCH  IF  IT IS DETERMINED THAT SUCH FURTHER
 PARTICIPATION IS NOT IN THE SUBJECT'S INTEREST; OR (B) WITHOUT  A  COURT
 ORDER  UPON  A FINDING BY SUCH COURT THAT THE SUBJECT LACKS THE CAPACITY
 TO PROVIDE VOLUNTARY INFORMED CONSENT  AND  THAT  PARTICIPATION  BY  THE
 SUBJECT IN SUCH HUMAN RESEARCH IS DETERMINED TO BE IN THE SUBJECT'S BEST
 INTEREST.
   IN  MAKING A DETERMINATION OF THE SUBJECT'S BEST INTEREST, THE FOLLOW-
 ING CRITERIA SHALL BE CONSIDERED: (I) THE RISKS AND  POTENTIAL  BENEFITS
 OF  THE  HUMAN  RESEARCH;  (II)  THE MEDICAL AND SCIENTIFIC ALTERNATIVES
 AVAILABLE TO THE SUBJECT, INCLUDING THE CHOICE NOT TO TREAT  THE  CONDI-
 TION;  AND  (III) WHETHER THE HUMAN RESEARCH PROTOCOL IS CONSISTENT WITH
 WHAT IS THEN KNOWN ABOUT THE WISHES, BELIEFS AND MORES OF THE SUBJECT.

 A. 2409                             6
 
   5. REGARDLESS OF CAPACITY TO CONSENT, NO ADULT SHALL BE A  SUBJECT  OF
 HUMAN  RESEARCH  IF HE OR SHE, AT ANY TIME, OBJECTS TO ACTIVE OR PASSIVE
 PARTICIPATION IN SUCH RESEARCH.
   6.  REGARDLESS  OF CAPACITY TO CONSENT, NO ADULT SHALL BE A SUBJECT OF
 HUMAN RESEARCH WITHOUT BEING FIRST NOTIFIED THAT HE OR SHE IS  TO  BE  A
 SUBJECT  OF HUMAN RESEARCH AND WITHOUT BEING FURTHER NOTIFIED THAT HE OR
 SHE HAS THE ABSOLUTE AND UNEQUIVOCAL RIGHT TO REFUSE TO  PARTICIPATE  IN
 SUCH HUMAN RESEARCH.
   §  2451.  MONITORING  HUMAN  RESEARCH. 1. FOR ALL GREATER THAN MINIMAL
 RISK RESEARCH ON INDIVIDUALS WITH A MENTAL DISORDER THAT  AFFECTS  DECI-
 SION MAKING CAPACITY, THE HUMAN RESEARCH REVIEW COMMITTEE MUST DESIGNATE
 A  MEDICALLY  RESPONSIBLE  CLINICIAN  TO EVALUATE WHETHER EACH SUBJECT'S
 PARTICIPATION IN RESEARCH IS APPROPRIATE.
   2. THE MEDICALLY RESPONSIBLE CLINICIAN  MUST  BE  A  LICENSED  MEDICAL
 DOCTOR  SKILLED  AND  KNOWLEDGEABLE  ABOUT  CARING  FOR PERSONS WITH THE
 CONDITIONS OR DISEASES PRESENTED BY THE SPECIFIC  STUDY  POPULATION  AND
 MUST  BE INDEPENDENT OF THE RESEARCH ENTITY, EXCEPT AS SPECIFIED IN THIS
 SUBDIVISION.
   FOR POSSIBLE THERAPEUTIC RESEARCH, THE MEDICALLY RESPONSIBLE CLINICIAN
 MAY BE THE SUBJECT'S ATTENDING PHYSICIAN OR A MEMBER  OF  THE  SUBJECT'S
 TREATMENT TEAM.
   3.  THE  DUTIES  OF  THE  MEDICALLY RESPONSIBLE CLINICIAN INCLUDE: (A)
 CONFIRMING THAT THE LEVEL OF RISK (MINIMAL RISK OR GREATER THAN  MINIMAL
 RISK) AND THE TYPE OF RESEARCH (POSSIBLY THERAPEUTIC OR NON-THERAPEUTIC)
 OF  THE  PROPOSED  RESEARCH  IS UNAMBIGUOUSLY AUTHORIZED BY THE RESEARCH
 ADVANCE DIRECTIVE, IF ONE EXISTS; (B) ENSURING THAT THE  RESEARCH  AGENT
 UNDERSTANDS THE GOALS AND RISKS OF THE RESEARCH, IF A RESEARCH AGENT HAS
 BEEN  DESIGNATED;  (C)  ENSURING  THAT  THE  SUBJECT ASSENTS TO RESEARCH
 PARTICIPATION, UNLESS THE SUBJECT HAS BEEN DETERMINED TO  LACK  CAPACITY
 TO  ASSENT; (D) MONITORING THE SUBJECT FOR POSSIBLE OBJECTION TO CONTIN-
 UED PARTICIPATION; AND (E) MONITORING THE SUBJECT TO ENSURE THAT CONTIN-
 UED RESEARCH PARTICIPATION WOULD NOT BE  DETRIMENTAL  TO  THE  SUBJECT'S
 WELL-BEING, CONSIDERING ALL RELEVANT CIRCUMSTANCES.
   §  2452. RESEARCH AGENT AND RESEARCH ADVANCE DIRECTIVE. 1. EVERY ADULT
 SHALL BE PRESUMED CAPABLE OF APPOINTING A  RESEARCH  AGENT  UNLESS  SUCH
 PERSON  HAS  BEEN  ADJUDGED  BY A COURT TO BE INCAPABLE OF MAKING HEALTH
 CARE DECISIONS OR ADJUDGED BY A COURT TO BE INCAPABLE  OF  APPOINTING  A
 RESEARCH  AGENT,  OR UNLESS A GUARDIAN HAS BEEN APPOINTED TO MAKE HEALTH
 CARE DECISIONS FOR THE ADULT  PURSUANT  TO  ARTICLE  EIGHTY-ONE  OF  THE
 MENTAL HYGIENE LAW OR HAS BEEN APPOINTED PURSUANT TO ARTICLE SEVENTEEN-A
 OF THE SURROGATE'S COURT PROCEDURE ACT.
   (A)  A  RESEARCH  AGENT  IS DESIGNATED BY EXECUTING A RESEARCH ADVANCE
 DIRECTIVE WHICH IS SIGNED AND DATED BY THE ADULT IN THE PRESENCE OF  TWO
 ADULT WITNESSES WHO SHALL ALSO SIGN THE RESEARCH ADVANCE DIRECTIVE.
   (B) THE WITNESSES SHALL STATE IN WRITING:
   (I)  THAT  THE  INDIVIDUAL  APPEARED  TO  EXECUTE THE RESEARCH ADVANCE
 DIRECTIVE WILLINGLY AND FREE FROM DURESS;
   (II) THAT THE INDIVIDUAL APPEARED TO UNDERSTAND THE DIFFERENCES  AMONG
 MEDICAL  TREATMENT,  POSSIBLY  THERAPEUTIC  RESEARCH AND NON-THERAPEUTIC
 RESEARCH;
   (III) THAT THE INDIVIDUAL APPEARED TO BE  ABLE  TO  EXPRESS  A  CHOICE
 ABOUT DELEGATING AUTHORITY FOR SPECIFIC RESEARCH PARTICIPATION DECISIONS
 TO  THE  NAMED  RESEARCH AGENT, UNDERSTANDING THAT SUCH AUTHORITY MAY BE
 REVOKED AT ANY TIME, MAY BE LIMITED TO SPECIFIC RISK-BENEFIT  CATEGORIES
 OF  RESEARCH  AND  WOULD  NOT  PREVENT  THE INDIVIDUAL FROM OBJECTING TO
 PARTICIPATE IN THE RESEARCH; AND

 A. 2409                             7
 
   (IV) THAT THE INDIVIDUAL APPEARED TO UNDERSTAND THAT HE OR SHE MAY ASK
 A COURT TO DESIGNATE A GUARDIAN TO MAKE A DETERMINATION AS TO THE  INDI-
 VIDUAL'S PARTICIPATION IN A PARTICULAR RESEARCH STUDY.
   2.  FOR  PERSONS  WHO  RESIDE IN A MENTAL HYGIENE FACILITY OPERATED OR
 LICENSED BY THE NEW YORK STATE OFFICE OF  MENTAL  HEALTH,  NO  WITNESSES
 SHALL BE AFFILIATED WITH THE FACILITY AND, IF THE MENTAL HYGIENE FACILI-
 TY  IS  ALSO A HOSPITAL AS DEFINED IN SUBDIVISION TEN OF SECTION 1.03 OF
 THE MENTAL HYGIENE LAW, AT  LEAST  ONE  WITNESS  SHALL  BE  A  QUALIFIED
 PSYCHIATRIST.
   3.  FOR  PERSONS  WHO  RESIDE IN A MENTAL HYGIENE FACILITY OPERATED OR
 LICENSED BY THE NEW YORK STATE OFFICE OF MENTAL RETARDATION AND DEVELOP-
 MENTAL DISABILITIES, NO WITNESSES SHALL BE AFFILIATED WITH THE FACILITY,
 AND AT LEAST ONE WITNESS SHALL BE A PHYSICIAN OR  CLINICAL  PSYCHOLOGIST
 WHO  EITHER IS EMPLOYED BY A SCHOOL NAMED IN SECTION 13.17 OF THE MENTAL
 HYGIENE LAW OR WHO HAS BEEN EMPLOYED FOR  A  MINIMUM  OF  TWO  YEARS  TO
 RENDER CARE AND SERVICE IN A FACILITY OPERATED OR LICENSED BY THE OFFICE
 OF  MENTAL  RETARDATION  AND DEVELOPMENTAL DISABILITIES, OR WHO HAS BEEN
 APPROVED BY THE COMMISSIONER OF  MENTAL  RETARDATION  AND  DEVELOPMENTAL
 DISABILITIES IN ACCORDANCE WITH REGULATIONS APPROVED BY THE COMMISSIONER
 WHICH  SHALL  REQUIRE  THAT A PHYSICIAN OR CLINICAL PSYCHOLOGIST POSSESS
 SPECIALIZED TRAINING OR THREE YEARS EXPERIENCE IN TREATING DEVELOPMENTAL
 DISABILITIES.
   4. AN OPERATOR, ADMINISTRATOR,  OR  EMPLOYEE  OF  A  HOSPITAL,  MENTAL
 HYGIENE  FACILITY,  OR PSYCHIATRIC UNIT OF A GENERAL HOSPITAL MAY NOT BE
 APPOINTED AS A RESEARCH AGENT BY ANY PERSON WHO,  AT  THE  TIME  OF  THE
 APPOINTMENT,  IS  A PATIENT OR RESIDENT OF, OR HAS APPLIED FOR ADMISSION
 TO, SUCH HOSPITAL, MENTAL HYGIENE FACILITY, OR  PSYCHIATRIC  UNIT  OF  A
 GENERAL  HOSPITAL,  UNLESS  THEY  ARE RELATED TO THE PRINCIPAL BY BLOOD,
 MARRIAGE OR ADOPTION.
   5. THE RESEARCH AGENT'S AUTHORITY SHALL COMMENCE UPON A  DETERMINATION
 THAT  THE INDIVIDUAL LACKS CAPACITY TO MAKE RESEARCH PARTICIPATION DECI-
 SIONS.
   6. RESEARCH ADVANCE DIRECTIVES EXECUTED BY PERSONS DETERMINED TO  LACK
 CAPACITY  TO PROVIDE VOLUNTARY INFORMED CONSENT TO RESEARCH BUT, MEETING
 THE REQUIREMENTS IN PARAGRAPH (B) OF SUBDIVISION  ONE  OF  THIS  SECTION
 SHALL  BE  LIMITED TO AUTHORIZING POSSIBLY THERAPEUTIC RESEARCH AND NON-
 THERAPEUTIC RESEARCH WHICH DOES NOT POSE MORE THAN MINIMAL RISK.
   7. THE RESEARCH ADVANCE DIRECTIVE SHALL:
   (A) IDENTIFY THE PRINCIPAL AND THE AGENT;
   (B) INDICATE THAT THE PRINCIPAL INTENDS THE AGENT TO HAVE AUTHORITY TO
 MAKE RESEARCH PARTICIPATION DECISIONS ON THE PRINCIPAL'S BEHALF;
   (C)  SPECIFY  THE  PRINCIPAL'S  INSTRUCTIONS  ABOUT  PARTICIPATION  IN
 SPECIFIC RISK-BENEFIT CATEGORIES OR SPECIFIC RESEARCH; AND
   (D)  INCLUDE A STATEMENT THAT RESEARCH IS DIFFERENT FROM CLINICAL CARE
 IN THAT RESEARCH IS DESIGNED TO GAIN  NEW  INFORMATION  THAT  WILL  HELP
 OTHER  PERSONS  IN THE FUTURE AND NOT NECESSARILY THE PARTICIPANT IN THE
 RESEARCH AND THAT, FOR SOME RESEARCH, THERE MAY BE NO  EXPECTED  MEDICAL
 BENEFIT FOR THE SUBJECT.
   8.  AFTER CONSULTATION WITH INTERESTED PERSONS, THE COMMISSIONER SHALL
 PREPARE AND DISTRIBUTE A MODEL FORM OF A RESEARCH ADVANCE DIRECTIVE, THE
 USE OF WHICH SHALL BE OPTIONAL.
   § 6. This act shall take effect on the one hundred twentieth day after
 it shall have become a law; provided that the commissioner of health  is
 authorized  to promulgate any and all rules and regulations and take any
 other measures necessary to implement this act on its effective date  on
 or before such effective date.