A01445 Summary:

SAME ASNo same as
Amd SS2441, 2442, 2444 & 2445, add SS2447 - 2452, Pub Health L
Regulates the use of human subjects for medical research and experimentation, including subjects with mental disorders and children; makes definitions; addresses exclusion or inclusion of subjects to participate in human research based on race, ethnicity or sex; requires reporting certain information relating to the collection of data; provides that no greater than minimal risk non-therapeutic human research shall be conducted on a child without consent of a parent or guardian; makes related provisions.
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A01445 Actions:

01/07/2009referred to health
01/06/2010referred to health
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A01445 Text:

                STATE OF NEW YORK
                               2009-2010 Regular Sessions
                   IN ASSEMBLY
                                     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.

        A. 1445                             2
     1  advance  directive  expressly  authorizing  participation in research in
     2  specific risk/benefit categories.

     3    14.  "Assent"  means affirmative agreement to participate in research.
     4  Mere failure to object does not constitute assent.
     5    15. "Adult" means (a) a person over the age of eighteen years and  (b)
     6  a  person  under  the  age of eighteen years who is (i) in a psychiatric
     7  facility on voluntary status on his or her own application, (ii) married
     8  or (iii) the parent of a child.
     9    16. "Child" means a person under the age of eighteen  who  is  not  an
    10  adult as defined herein.
    11    § 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

        A. 1445                             3
     1  less  than one member, must be a person with such a disorder or a family

     2  member of such person, or a representative of an  advocacy  organization
     3  concerned  with  the  welfare  of  such persons. When the human research
     4  review  committee reviews human research in which race, ethnicity or sex
     5  is proposed to be a factor affecting either inclusion or exclusion  from
     6  human  research,  at least fifteen percent of the committee members, but
     7  no less than one, must be a member of the race, ethnicity or  sex  which
     8  is proposed to be included or excluded.
     9    2.  The  human research review committee in each institution or agency
    10  shall require that institution or agency to promulgate  a  statement  of
    11  principle  and  policy  in  regard  to  the  rights and welfare of human
    12  subjects in the conduct of human research, and  the  committee  and  the

    13  commissioner  shall  approve  that statement prior to its taking effect.
    14  The committee shall review  each  proposed  human  research  project  to
    15  determine  (1)  its  necessity;  (2)  that the rights and welfare of the
    16  human subjects involved are adequately protected, (3) that the risks  to
    17  the  human  subjects are outweighed by the potential benefits to them or
    18  by the importance of the knowledge to be gained; (4) that the  voluntary
    19  informed  consent  is  to  be  obtained by methods that are adequate and
    20  appropriate, and (5) that the persons proposed to conduct the particular
    21  medical research are appropriately competent and qualified. The  commit-
    22  tee shall periodically examine each existing human research project with
    23  regard to the proper application of the approved principles and policies
    24  which  the  institution  or  agency has promulgated. The committee shall

    25  report any violation to the commissioner. In addition to  the  voluntary
    26  informed  consent  of  the proposed human subject as required by section
    27  twenty-four hundred forty-two of this [chapter] article, the consent  of
    28  the  committee  and  the commissioner shall be required with relation to
    29  the conduct of human research involving  minors,  [incompetent  persons,
    30  mentally  disabled  persons]  subjects  with  mental  disorders that may
    31  affect decision making capacity and prisoners.  All documents related to
    32  requests seeking the  consent  of  the  commissioner  to  conduct  human
    33  research on minors, subjects with mental disorders that may affect deci-
    34  sion  making  capacity,  and prisoners, and the commissioner's ruling on

    35  such requests, shall be made available to  the  public  upon  reasonable
    36  request,  provided that the commissioner may redact proprietary informa-
    37  tion and trade secrets. The nature of the risks and the  nature  of  the
    38  procedures which are proposed to be conducted shall not be considered to
    39  be proprietary information or a trade secret.
    40    3.  Each  person engaged in the conduct of human research or proposing
    41  to conduct human research shall affiliate himself  or  herself  with  an
    42  institution or agency having a human research review committee, and such
    43  human  research  as  he  or she conducts or proposes to conduct shall be
    44  subject to review by such committee in the  manner  set  forth  in  this
    45  section.
    46    4.  No institution or agency shall retaliate against any member of its

    47  human research review committee for any action taken  by  the  committee
    48  member  in connection with his or her work on the committee which may or
    49  may not have had adverse effects on the research entity and any  of  its
    50  protocols.  Any such aggrieved person may commence an action pursuant to
    51  the provisions of this article as if such aggrieved person were a  human
    52  subject for the purposes of commencing such an action.
    53    § 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

        A. 1445                             4

     1  is in compliance with, policies and regulations promulgated by any agen-
     2  cy  of  the  federal  government  for  the protection of human subjects]
     3  conducted within the state of New York.
     4    § 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.

        A. 1445                             5
     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.

        A. 1445                             6
     1    5. Regardless of capacity to consent, no adult shall be a  subject  of
     2  human  research  if he or she, at any time, objects to active or passive
     3  participation in such research.
     4    6.  Regardless  of capacity to consent, no adult shall be a subject of
     5  human research without being first notified that he or she is  to  be  a
     6  subject  of human research and without being further notified that he or
     7  she has the absolute and unequivocal right to refuse to  participate  in
     8  such human research.

     9    §  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

        A. 1445                             7
     1    (iv) that the individual appeared to understand that he or she may ask
     2  a court to designate a guardian to make a determination as to the  indi-
     3  vidual's participation in a particular research study.
     4    2.  For  persons  who  reside in a mental hygiene facility operated or
     5  licensed by the New York state office of  mental  health,  no  witnesses
     6  shall be affiliated with the facility and, if the mental hygiene facili-

     7  ty  is  also a hospital as defined in subdivision ten of section 1.03 of
     8  the mental hygiene law, at  least  one  witness  shall  be  a  qualified
     9  psychiatrist.
    10    3.  For  persons  who  reside in a mental hygiene facility operated or
    11  licensed by the New York state office of mental retardation and develop-
    12  mental disabilities, no witnesses shall be affiliated with the facility,
    13  and at least one witness shall be a physician or  clinical  psychologist
    14  who  either is employed by a school named in section 13.17 of the mental
    15  hygiene law or who has been employed for  a  minimum  of  two  years  to
    16  render care and service in a facility operated or licensed by the office
    17  of  mental  retardation  and developmental disabilities, or who has been

    18  approved by the commissioner of  mental  retardation  and  developmental
    19  disabilities in accordance with regulations approved by the commissioner
    20  which  shall  require  that a physician or clinical psychologist possess
    21  specialized training or three years experience in treating developmental
    22  disabilities.
    23    4. An operator, administrator,  or  employee  of  a  hospital,  mental
    24  hygiene  facility,  or psychiatric unit of a general hospital may not be
    25  appointed as a research agent by any person who,  at  the  time  of  the
    26  appointment,  is  a patient or resident of, or has applied for admission
    27  to, such hospital, mental hygiene facility, or  psychiatric  unit  of  a
    28  general  hospital,  unless  they  are related to the principal by blood,

    29  marriage or adoption.
    30    5. The research agent's authority shall commence upon a  determination
    31  that  the individual lacks capacity to make research participation deci-
    32  sions.
    33    6. Research advance directives executed by persons determined to  lack
    34  capacity  to provide voluntary informed consent to research but, meeting
    35  the requirements in paragraph (b) of subdivision  one  of  this  section
    36  shall  be  limited to authorizing possibly therapeutic research and 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.
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