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

                                  2931

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                            January 22, 2013
                               ___________

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:

  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.
                                                           LBD00790-01-3

A. 2931                             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.
  S 2. Section 2442 of the public health law, as added by chapter 450 of
the laws of 1975, is amended to read as follows:
  S  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.
  S 3. Section 2444 of the public health law, as added by chapter 450 of
the laws of 1975, is amended to read as follows:
  S 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. 2931                             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.
  S 4. Section 2445 of the public health law, as added by chapter 450 of
the laws of 1975, is amended to read as follows:
  S  2445.  Applicability.    The provisions of this article shall [not]
apply to the conduct of human research [which is subject to,  and  which

A. 2931                             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.
  S 5. The public health law is amended by adding six new sections 2447,
2448, 2449, 2450, 2451 and 2452 to read as follows:
  S  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.
  S 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. 2931                             5

  ALL SUCH DATA COLLECTED SHALL BE MADE AVAILABLE  TO  THE  PUBLIC  UPON
REASONABLE REQUEST.
  S  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.
  S 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. 2931                             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.
  S  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.
  S  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. 2931                             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.
  S 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.