S T A T E O F N E W Y O R K
________________________________________________________________________
3921
2015-2016 Regular Sessions
I N A S S E M B L Y
January 28, 2015
___________
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.
LBD04972-01-5
A. 3921 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
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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
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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.
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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.
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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
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(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.