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A03802 Summary:

BILL NOA03802
 
SAME ASNo Same As
 
SPONSORDickens
 
COSPNSR
 
MLTSPNSR
 
Amd §§2441, 2442, 2444 & 2445, add §§2447 - 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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A03802 Actions:

BILL NOA03802
 
01/28/2021referred to health
01/05/2022referred to health
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A03802 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          3802
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 28, 2021
                                       ___________
 
        Introduced  by M. of A. DICKENS -- read once and referred to the Commit-
          tee on Health
 
        AN ACT to amend the public health law, in relation to human research
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:

     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.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD03695-01-1

        A. 3802                             2
 
     1    13. "Research agent" means a legally authorized representative to whom
     2  authority  to  make  research  decisions  is  delegated under a research
     3  advance directive expressly authorizing  participation  in  research  in
     4  specific risk/benefit categories.
     5    14.  "Assent"  means affirmative agreement to participate in research.
     6  Mere failure to object does not constitute assent.
     7    15. "Adult" means (a) a person over the age of eighteen years and  (b)
     8  a  person  under  the  age of eighteen years who is (i) in a psychiatric
     9  facility on voluntary status on his or her own application, (ii) married
    10  or (iii) the parent of a child.
    11    16. "Child" means a person under the age of eighteen  who  is  not  an
    12  adult as defined herein.
    13    § 2. Section 2442 of the public health law, as added by chapter 450 of
    14  the laws of 1975, is amended to read as follows:
    15    §  2442.  Informed consent.   1. No human research may be conducted in
    16  this state in the absence of the voluntary informed  consent  subscribed
    17  to  in  writing  by  the human subject. If the human subject be a minor,
    18  such consent shall be subscribed to in writing by the minor's parent  or
    19  legal  guardian.  If  the  human  subject be otherwise legally unable to
    20  render consent, such consent shall be subscribed to in writing  by  such
    21  other  person  as may be legally empowered to act on behalf of the human
    22  subject. No such voluntary informed consent shall include  any  language
    23  through  which the human subject waives, or appears to waive, any of his
    24  or her legal rights, including any release of any  individual,  institu-
    25  tion or agency, or any agents thereof, from liability for negligence.
    26    2.  Any  adult  person  who  is determined to lack capacity to provide
    27  voluntary informed consent to human research shall be  informed  of  the
    28  following  if  it is proposed to nevertheless use such person as a human
    29  subject: (a) that he or she has been found to lack capacity  to  make  a
    30  decision regarding the research; (b) of the right to object to any human
    31  research  he or she may be placed in; (c) of the right to appeal a find-
    32  ing of an incapacity to make a decision;  (d)  of  the  availability  of
    33  legal  counsel to assist  in appealing a finding of such incapacity; (e)
    34  whether the proposed human research is possibly therapeutic or non-ther-
    35  apeutic; (f) the information described in subdivision  five  of  section
    36  twenty-four  hundred  forty-one of this article; (g) the identity of the
    37  person who is proposed to act as a surrogate decision maker; and (h) the
    38  availability of legal counsel to challenge the identity of the surrogate
    39  decision maker.
    40    § 3. Section 2444 of the public health law, as added by chapter 450 of
    41  the laws of 1975, is amended to read as follows:
    42    § 2444. Human research review committees.  1. Each public  or  private
    43  institution  or  agency  which conducts, or which proposes to conduct or
    44  authorize, human research,  shall  establish  a  human  research  review
    45  committee.  Such  committee  shall  be  composed  of  not less than five
    46  persons, approved by the commissioner, who have such varied  backgrounds
    47  as  to  assure  the competent, complete and professional review of human
    48  research activities conducted or proposed to be conducted or  authorized
    49  by the institution or agency. No member of a committee shall be involved
    50  in either the initial or continuing review of an activity in which he or
    51  she  has  a conflicting interest, except to provide information required
    52  by the committee. No committee shall consist entirely of persons who are
    53  officers, employees, or agents of, or who are otherwise associated  with
    54  the institution or agency, apart from their membership on the committee,
    55  and  no  committee shall consist entirely of members of a single profes-
    56  sional group.  When the human research review  committee  reviews  human

        A. 3802                             3
 
     1  research  involving subjects with mental disorders that may affect deci-
     2  sion making capacity, fifteen percent of the committee members,  but  no
     3  less  than one member, must be a person with such a disorder or a family
     4  member  of  such person, or a representative of an advocacy organization
     5  concerned with the welfare of such  persons.  When  the  human  research
     6  review  committee reviews human research in which race, ethnicity or sex
     7  is proposed to be a factor affecting either inclusion or exclusion  from
     8  human  research,  at least fifteen percent of the committee members, but
     9  no less than one, must be a member of the race, ethnicity or  sex  which
    10  is proposed to be included or excluded.
    11    2.  The  human research review committee in each institution or agency
    12  shall require that institution or agency to promulgate  a  statement  of
    13  principle  and  policy  in  regard  to  the  rights and welfare of human
    14  subjects in the conduct of human research, and  the  committee  and  the
    15  commissioner  shall  approve  that statement prior to its taking effect.
    16  The committee shall review  each  proposed  human  research  project  to
    17  determine  (1)  its  necessity;  (2)  that the rights and welfare of the
    18  human subjects involved are adequately protected, (3) that the risks  to
    19  the  human  subjects are outweighed by the potential benefits to them or
    20  by the importance of the knowledge to be gained; (4) that the  voluntary
    21  informed  consent  is  to  be  obtained by methods that are adequate and
    22  appropriate, and (5) that the persons proposed to conduct the particular
    23  medical research are appropriately competent and qualified. The  commit-
    24  tee shall periodically examine each existing human research project with
    25  regard to the proper application of the approved principles and policies
    26  which  the  institution  or  agency has promulgated. The committee shall
    27  report any violation to the commissioner. In addition to  the  voluntary
    28  informed  consent  of  the proposed human subject as required by section
    29  twenty-four hundred forty-two of this [chapter] article, the consent  of
    30  the  committee  and  the commissioner shall be required with relation to
    31  the conduct of human research involving  minors,  [incompetent  persons,
    32  mentally  disabled  persons]  subjects  with  mental  disorders that may
    33  affect decision making capacity and prisoners.  All documents related to
    34  requests seeking the  consent  of  the  commissioner  to  conduct  human
    35  research on minors, subjects with mental disorders that may affect deci-
    36  sion  making  capacity,  and prisoners, and the commissioner's ruling on
    37  such requests, shall be made available to  the  public  upon  reasonable
    38  request,  provided that the commissioner may redact proprietary informa-
    39  tion and trade secrets. The nature of the risks and the  nature  of  the
    40  procedures which are proposed to be conducted shall not be considered to
    41  be proprietary information or a trade secret.
    42    3.  Each  person engaged in the conduct of human research or proposing
    43  to conduct human research shall affiliate himself  or  herself  with  an
    44  institution or agency having a human research review committee, and such
    45  human  research  as  he  or she conducts or proposes to conduct shall be
    46  subject to review by such committee in the  manner  set  forth  in  this
    47  section.
    48    4.  No institution or agency shall retaliate against any member of its
    49  human research review committee for any action taken  by  the  committee
    50  member  in connection with his or her work on the committee which may or
    51  may not have had adverse effects on the research entity and any  of  its
    52  protocols.  Any such aggrieved person may commence an action pursuant to
    53  the provisions of this article as if such aggrieved person were a  human
    54  subject for the purposes of commencing such an action.

        A. 3802                             4
 
     1    §  4.  Subdivision  1  of  section  2445  of the public health law, as
     2  amended by chapter 309 of the laws  of  2019,  is  amended  to  read  as
     3  follows:
     4    1.  The provisions of this article shall [not] apply to the conduct of
     5  human research [which is subject to, and which is  in  compliance  with,
     6  policies  and  regulations  promulgated  by  any  agency  of the federal
     7  government for the protection of human subjects]  conducted  within  the
     8  state of New York.
     9    § 5. The public health law is amended by adding six new sections 2447,
    10  2448, 2449, 2450, 2451 and 2452 to read as follows:
    11    §  2447.  Exclusion  or  inclusion of subjects to participate in human
    12  research based on race, ethnicity or sex. 1. When race, ethnicity or sex
    13  is proposed to be a factor affecting either inclusion or exclusion  from
    14  human  research,  the  entity  proposing such research protocol shall be
    15  provided to the commissioner, with specificity,  the  criteria  and  the
    16  reasons  why  it is necessary to include or exclude members of a partic-
    17  ular race, ethnic or sexual population, which shall include the goals of
    18  such research.
    19    2. No such human research shall be conducted unless it is demonstrated
    20  that such research is necessary and  that  such  research  is  the  only
    21  manner  by  which  the  sought  after information may be obtained.   The
    22  approval of the commissioner shall only be granted upon  the  submission
    23  of  such  proof. All requests presented to the commissioner seeking such
    24  approval shall be published in the state register sixty  days  prior  to
    25  the commissioner making a decision about such request.
    26    3. This section will not apply to any human research which attempts to
    27  enroll  subjects based on race, ethnicity or sex when such enrollment is
    28  an attempt to produce  the  numerical  representation  of  these  races,
    29  ethnicities  or sexes in the general population of this state in partic-
    30  ular or the United States in general.
    31    § 2448. Collection of data. On the first business day of March, on  an
    32  annual basis, all entities conducting human research shall file with the
    33  commissioner  the  following  information relative to all human research
    34  conducted in this state in the immediately preceding calendar year:
    35    1. an abstract of each human research protocol which shall  include  a
    36  description  of  the  hypothesis  of  the research, the various research
    37  procedures utilized and the risks and benefits which were  presented  by
    38  such research procedures to the human research subjects exposed thereto;
    39    2.  the  number of subjects which were involved in each human research
    40  protocol;
    41    3. an itemization of the number of subjects  involved  in  each  human
    42  research  protocol by race, ethnicity, age, sex, capacity to consent and
    43  mental disorder and a statement of how such consent  was  obtained  when
    44  such mental disorder is extant which shall be supported by a copy of the
    45  relevant consent form;
    46    4.  a  statement  as  to  whether  the human research review committee
    47  consider such human research to be non-therapeutic or possibly therapeu-
    48  tic;
    49    5. a statement as to  whether  the  human  research  review  committee
    50  considered  such  human research to present minimal risk or greater than
    51  minimal risk;
    52    6. a description of the type  of  diseases,  illnesses,  symptoms  and
    53  conditions which were studied in each such research protocol; and
    54    7.  a  report  of  any  unusual incidents or negative impacts, if any,
    55  suffered by the human subjects as a result of such research.

        A. 3802                             5
 
     1    Failure to file this information on the required date, shall result in
     2  the immediate discontinuance of all human research for which such infor-
     3  mation was not provided, in a manner that safeguards the well  being  of
     4  the subjects. Furthermore, the commissioner shall halt further consider-
     5  ation  of  any new requests pending before him or her until such time as
     6  the research entity is in compliance.
     7    All such data collected shall be made available  to  the  public  upon
     8  reasonable request.
     9    §  2449.  Determination  of  capacity  to  provide informed consent to
    10  greater than minimal risk human research. No person shall be presumed to
    11  lack capacity to provide voluntary informed consent  to  human  research
    12  solely  because  of  the  presence  of a mental disorder that may affect
    13  decision making capacity. However, for any  subject  who  has  a  mental
    14  disorder  which  may affect decision making capacity and for any subject
    15  who possesses questionable decision making capacity, a finding  must  be
    16  made  as  to  whether such subject has the capacity to provide voluntary
    17  informed consent, and, if not, whether such subject has the capacity  to
    18  assent.
    19    Such  a determination of capacity is a condition which must be met and
    20  made by a board certified psychiatrist who is independent of  the  human
    21  research entity and not employed by the institution conducting, sponsor-
    22  ing  or housing such research, prior to the subject participating in any
    23  human research.
    24    § 2450. Permissible human research on children and  persons  who  lack
    25  capacity  to  provide  voluntary  informed consent.   1. No greater than
    26  minimal risk, non-therapeutic human research shall  be  conducted  on  a
    27  child. However, a child may participate in possibly therapeutic, minimal
    28  risk  and possible therapeutic, greater than minimal risk human research
    29  if the parent or legal guardian has provided voluntary informed consent.
    30    2. Except as otherwise provided in this section, no greater than mini-
    31  mal risk, non-therapeutic human research shall be  conducted  on  adults
    32  who  lack  capacity  to provide voluntary informed consent to such human
    33  research.
    34    3. An adult who lacks capacity to provide voluntary  informed  consent
    35  may  become  a  subject  of  greater  than minimal risk, non-therapeutic
    36  research provided that: (a) such adult provided such voluntary  informed
    37  consent  prior  to  such  incapacity  having  developed by designating a
    38  research agent and executing  a  research  advance  directive;  (b)  the
    39  research  is  expected to yield generalizable knowledge important to the
    40  understanding or amelioration of the subject's  disorder  or  condition;
    41  (c)  the  knowledge cannot be obtained without his or her participation;
    42  and (d) the subject assents, unless the individual has  been  determined
    43  to lack capacity to assent.
    44    4.  No  possible therapeutic, greater than minimal risk human research
    45  shall be conducted on an adult who lacks capacity to  provide  voluntary
    46  informed  consent  to human research: (a) without the voluntary informed
    47  consent of the guardian or committee of the subject who is authorized to
    48  (i) consent to possibly therapeutic research; (ii) monitor such research
    49  and (iii) withdraw the consent and remove  the  subject  from  continued
    50  participation  in  the  research  if  it is determined that such further
    51  participation is not in the subject's interest; or (b) without  a  court
    52  order  upon  a finding by such court that the subject lacks the capacity
    53  to provide voluntary informed consent  and  that  participation  by  the
    54  subject in such human research is determined to be in the subject's best
    55  interest.

        A. 3802                             6
 
     1    In  making a determination of the subject's best interest, the follow-
     2  ing criteria shall be considered: (i) the risks and  potential  benefits
     3  of  the  human  research;  (ii)  the medical and scientific alternatives
     4  available to the subject, including the choice not to treat  the  condi-
     5  tion;  and  (iii) whether the human research protocol is consistent with
     6  what is then known about the wishes, beliefs and mores of the subject.
     7    5. Regardless of capacity to consent, no adult shall be a  subject  of
     8  human  research  if he or she, at any time, objects to active or passive
     9  participation in such research.
    10    6. Regardless of capacity to consent, no adult shall be a  subject  of
    11  human  research  without  being first notified that he or she is to be a
    12  subject of human research and without being further notified that he  or
    13  she  has  the absolute and unequivocal right to refuse to participate in
    14  such human research.
    15    § 2451. Monitoring human research. 1. For  all  greater  than  minimal
    16  risk  research  on individuals with a mental disorder that affects deci-
    17  sion making capacity, the human research review committee must designate
    18  a medically responsible clinician to  evaluate  whether  each  subject's
    19  participation in research is appropriate.
    20    2.  The  medically  responsible  clinician  must be a licensed medical
    21  doctor skilled and knowledgeable  about  caring  for  persons  with  the
    22  conditions  or  diseases  presented by the specific study population and
    23  must be independent of the research entity, except as specified in  this
    24  subdivision.
    25    For possible therapeutic research, the medically responsible clinician
    26  may  be  the  subject's attending physician or a member of the subject's
    27  treatment team.
    28    3. The duties of the  medically  responsible  clinician  include:  (a)
    29  confirming  that the level of risk (minimal risk or greater than minimal
    30  risk) and the type of research (possibly therapeutic or non-therapeutic)
    31  of the proposed research is unambiguously  authorized  by  the  research
    32  advance  directive,  if one exists; (b) ensuring that the research agent
    33  understands the goals and risks of the research, if a research agent has
    34  been designated; (c) ensuring  that  the  subject  assents  to  research
    35  participation,  unless  the subject has been determined to lack capacity
    36  to assent; (d) monitoring the subject for possible objection to  contin-
    37  ued participation; and (e) monitoring the subject to ensure that contin-
    38  ued  research  participation  would  not be detrimental to the subject's
    39  well-being, considering all relevant circumstances.
    40    § 2452. Research agent and research advance directive. 1. Every  adult
    41  shall  be  presumed  capable  of appointing a research agent unless such
    42  person has been adjudged by a court to be  incapable  of  making  health
    43  care  decisions  or  adjudged by a court to be incapable of appointing a
    44  research agent, or unless a guardian has been appointed to  make  health
    45  care  decisions  for  the  adult  pursuant  to article eighty-one of the
    46  mental hygiene law or has been appointed pursuant to article seventeen-A
    47  of the surrogate's court procedure act.
    48    (a) A research agent is designated by  executing  a  research  advance
    49  directive  which is signed and dated by the adult in the presence of two
    50  adult witnesses who shall also sign the research advance directive.
    51    (b) The witnesses shall state in writing:
    52    (i) that the individual  appeared  to  execute  the  research  advance
    53  directive willingly and free from duress;
    54    (ii)  that the individual appeared to understand the differences among
    55  medical treatment, possibly  therapeutic  research  and  non-therapeutic
    56  research;

        A. 3802                             7
 
     1    (iii)  that  the  individual  appeared  to be able to express a choice
     2  about delegating authority for specific research participation decisions
     3  to the named research agent, understanding that such  authority  may  be
     4  revoked  at any time, may be limited to specific risk-benefit categories
     5  of  research  and  would  not  prevent  the individual from objecting to
     6  participate in the research; and
     7    (iv) that the individual appeared to understand that he or she may ask
     8  a court to designate a guardian to make a determination as to the  indi-
     9  vidual's participation in a particular research study.
    10    2.  For  persons  who  reside in a mental hygiene facility operated or
    11  licensed by the New York state office of  mental  health,  no  witnesses
    12  shall be affiliated with the facility and, if the mental hygiene facili-
    13  ty  is  also a hospital as defined in subdivision ten of section 1.03 of
    14  the mental hygiene law, at  least  one  witness  shall  be  a  qualified
    15  psychiatrist.
    16    3.  For  persons  who  reside in a mental hygiene facility operated or
    17  licensed by the New York state office of mental retardation and develop-
    18  mental disabilities, no witnesses shall be affiliated with the facility,
    19  and at least one witness shall be a physician or  clinical  psychologist
    20  who  either is employed by a school named in section 13.17 of the mental
    21  hygiene law or who has been employed for  a  minimum  of  two  years  to
    22  render care and service in a facility operated or licensed by the office
    23  of  mental  retardation  and developmental disabilities, or who has been
    24  approved by the commissioner of  mental  retardation  and  developmental
    25  disabilities in accordance with regulations approved by the commissioner
    26  which  shall  require  that a physician or clinical psychologist possess
    27  specialized training or three years experience in treating developmental
    28  disabilities.
    29    4. An operator, administrator,  or  employee  of  a  hospital,  mental
    30  hygiene  facility,  or psychiatric unit of a general hospital may not be
    31  appointed as a research agent by any person who,  at  the  time  of  the
    32  appointment,  is  a patient or resident of, or has applied for admission
    33  to, such hospital, mental hygiene facility, or  psychiatric  unit  of  a
    34  general  hospital,  unless  they  are related to the principal by blood,
    35  marriage or adoption.
    36    5. The research agent's authority shall commence upon a  determination
    37  that  the individual lacks capacity to make research participation deci-
    38  sions.
    39    6. Research advance directives executed by persons determined to  lack
    40  capacity  to provide voluntary informed consent to research but, meeting
    41  the requirements in paragraph (b) of subdivision  one  of  this  section
    42  shall  be  limited to authorizing possibly therapeutic research and non-
    43  therapeutic research which does not pose more than minimal risk.
    44    7. The research advance directive shall:
    45    (a) identify the principal and the agent;
    46    (b) indicate that the principal intends the agent to have authority to
    47  make research participation decisions on the principal's behalf;
    48    (c)  specify  the  principal's  instructions  about  participation  in
    49  specific risk-benefit categories or specific research; and
    50    (d)  include a statement that research is different from clinical care
    51  in that research is designed to gain  new  information  that  will  help
    52  other  persons  in the future and not necessarily the participant in the
    53  research and that, for some research, there may be no  expected  medical
    54  benefit for the subject.

        A. 3802                             8

     1    8.  After consultation with interested persons, the commissioner shall
     2  prepare and distribute a model form of a research advance directive, the
     3  use of which shall be optional.
     4    § 6. This act shall take effect on the one hundred twentieth day after
     5  it shall have become a law.  Effective immediately, the addition, amend-
     6  ment and/or repeal of any rule or regulation necessary for the implemen-
     7  tation  of  this act on its effective date are authorized to be made and
     8  completed on or before such effective date.
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