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.
STATE OF NEW YORK
________________________________________________________________________
1445
2009-2010 Regular Sessions
IN ASSEMBLY(Prefiled)
January 7, 2009
___________
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.
LBD00216-01-9
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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 § 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 § 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 § 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 § 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
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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 § 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 § 2445. Applicability. The provisions of this article shall [not]
56 apply to the conduct of human research [which is subject to, and which
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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 § 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 § 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 § 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.
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1 All such data collected shall be made available to the public upon
2 reasonable request.
3 § 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 § 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.
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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 § 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 § 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
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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 non-
37 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 § 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.
