New York Codes, Rules and Regulations › Title 14 - DEPARTMENT OF MENTAL HYGIENE › Chapter XIV - Office for People With Developmental Disabilities › Part 633 - Protection of Individuals Receiving Services in Facilities and Services Operated and/or Certified by OPWDD › Section 633.13 - Research involving persons in OPWDD facilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Principles of compliance.
(1) The understanding, prevention and
				amelioration of developmental disabilities are significantly enhanced by
				knowledge gained through research (see glossary). This section seeks to ensure
				the protection of participants (see glossary) in research while, at the same
				time, facilitating research into the very conditions and disorders from which
				they suffer and which underlie their impairment.
(2) Requirements for conducting research in
				facilities operated or certified by OPWDD involving persons with developmental
				disabilities.
(i) All research.
(a) Subsequent to the effective date of this
				section, all facilities or entities (see glossary) which will conduct research
				involving participants with developmental disabilities must submit to the
				commissioner a copy of their federally approved assurance of compliance with
				regulations for the protection of human subjects (see glossary), or an
				alternate assurance certifying compliance with the provisions of   45 CFR 46, in
				a format specified by the commissioner.
(1)
				Initial and updated assurances shall be submitted at times specified by the
				commissioner.
(2) No research may
				be initiated unless a current approved assurance is on file with the
				commissioner.
(3) If a State
				operated facility has been included under OPWDD's federally approved assurance
				of compliance, it shall be deemed to have met the above requirements. State
				operated facilities that have not been included as of the date of promulgation
				of this section will meet the requirements upon submission of appropriate
				documentation to the Research Foundation for Mental Hygiene, Inc., and approval
				therefrom.
(4) The
Code of
				Federal Regulations
(CFR) is published by the Office of the
Federal Register,
National Archives and Records Service,
				General Services Administration, and is available for purchase from the
				Superintendent of Documents, U.S. Government Printing Office, Washington, DC
				20402; or it is available for review during business hours and by appointment
				at the following locations:
(i) the Department
				of State, Division of Information Services, 11th Floor, 41 State Street,
				Albany, NY 12207; and
(ii) the
				Office for People With Developmental Disabilities, Attention: Public Access
				Officer, 44 Holland Avenue, Albany, NY 12229.
(b) Participation as a subject in any
				research project or activity shall not deprive any participant of the rights,
				privileges and protections provided to all other persons in facilities.
				Included in these rights is the right to give informed consent (see glossary)
				or withhold such consent for proposed research, except as provided for in
				subclauses (
8
) and (
9
) of this clause; or to
				have an authorized surrogate (see glossary), as specified in clauses
				(a)(3)(ii)(
b
) and (a)(3)(iii)(
b
) of this
				section, consent or withhold consent for research involving a participant who
				lacks the capacity to consent.
(1) If a
				participant has sufficient capacity to give informed consent, the decision of
				the participant shall be honored, and consent or objection by a surrogate shall
				not be considered.
(2) No
				participant, regardless of capacity to consent or lack of capacity to consent,
				shall take part in research over his/her objection except as provided in clause
				(a)(3)(i)(
e
) of this section.
(3) Participants may only take part in
				research which does not come into substantive conflict with their individual
				plan of services.
(4) All research
				proposals must be approved by, and the ensuing research be subject to the
				ongoing review and monitoring of, a State or federally approved Institutional
				Review Board (IRB) (see glossary).
(5) All research proposals shall be reviewed
				and approved by the chief executive officer of the facility responsible for the
				participant(s).
(6) Proposed
				research projects or activities involving participants in OPWDD operated
				facilities and research which is conducted by or at OPWDD operated facilities,
				are to be approved by OPWDD.
(7)
				These requirements shall not diminish the obligation of researchers,
				facilities, and institutional review boards to comply with applicable Federal
				or State laws, rules or regulations.
(8) The requirements for obtaining informed
				consent can be waived by a State or federally approved IRB if the research
				involves only the review of records, and the researcher will have no personal
				contact with any of the subjects of the research in the facility. In this
				instance, the commissioner can consent to the release of information to
				qualified researchers upon the approval of a State or federally approved
				Institutional Review Board, provided that the researcher shall in no event
				disclose information tending to identify any person in the facility.
(9) The requirements for obtaining informed
				consent can be waived by a State or federally approved IRB if the research
				involves only the analysis of previously collected tissue specimens or bodily
				fluids provided that the subjects cannot be identified directly or through
				identifiers attached to the material.
(c) In addition to meeting the general
				requirements for approval, research which involves adult participants who lack
				the capacity to give informed consent may not be approved unless the IRB has
				determined and documented that the study could not be carried out without the
				involvement of participants who lack the capacity to give informed consent.
(ii) Research involving
				more than minimal risk (see glossary).
(a)
				Informed consent shall always be obtained in conformance with paragraphs (3)
				and (4) of this subdivision.
(b)
				Research involving more than minimal risk which takes place in or involves
				participant(s) from an OPWDD residential or day services facility shall only
				include participants who have been duly admitted to that facility.
(c) A person's program planning team shall
				make the determination as to whether research which involves more than minimal
				risk comes in substantive conflict with the person's individual plan of
				services. The determination shall be documented in the plan of
				services.
(d) Research which
				involves more than minimal risk and/or invasive procedures may only involve
				persons who lack the capacity to consent if the IRB has also determined and
				documented that the project is likely to produce knowledge which has overriding
				therapeutic importance for the understanding or treatment of a condition which
				is presented by the person(s) who will be participating. Concurrence of the
				chief executive officer of the facility is also required prior to
				implementation.
(3) Informed consent requirements by or for
				adult persons in facilities.
(i) All
				research.
(a) The informed consent of adult
				participants, or their legally authorized surrogates as specified in clauses
				(a)(3)(ii)(
b
) and (a)(3)(iii)(
b
) of this
				section, shall be obtained and documented in accordance with, and to the extent
				required by, the provisions of 45 CFR 46. At the time of promulgation of this
				section,
				45 CFR
				46.116, .117 and .408 contain the pertinent
				information.
(b) The IRB shall be
				responsible for the initial and continuing review and monitoring of research
				projects. The IRB shall review the consent procedures proposed by the
				researcher(s) and satisfy itself that all of the required elements are
				incorporated under circumstances that promote informed consent as specified in
				45 CFR
				46.116.
(c) A participant shall have the right to
				withdraw consent. If a participant lacks the capacity to consent, the
				participant's legally authorized surrogate may also withdraw consent to
				continue. Withdrawal from participation shall be conducted in a manner
				consistent with good clinical practice.
(d) No capable participant shall become or
				remain a research subject over his or her objection.
(e) No participant who lacks the capacity to
				give informed consent shall become or remain a research subject over his or her
				objection or the objection of a surrogate party authorized under clause
				(a)(3)(ii)(
b
) or (a)(3)(iii)(
b
) of this
				section to consent on behalf of the participant, unless such research is
				specifically authorized by a court of competent jurisdiction. If application is
				made to a court subsequent to the objection of one of the above parties, notice
				of such application shall be given to the objecting party and the Mental
				Hygiene Legal Service. Application to a court to override the objection of a
				participant or party authorized to consent shall be made only if it is
				considered to be in the best interest of the participant. Objection by a
				participant may be conveyed in whatever manner is typically utilized by the
				person to communicate a meaningful decision.
(f) If a party, other than the surrogate
				party authorized to consent on behalf of the participant under clause
				(a)(3)(ii)(
b
) or (a)(3)(iii)(
b
) of this
				section, objects to the participant's involvement in the research, the
				procedures for objection and appeal contained in section
				633.12 
				of this Part shall apply.
(ii) Research involving no more than minimal
				risk.
(a) For research which involves no more
				than minimal risk, and with the approval of the chief executive officer, the
				IRB may permit the researcher to assess the potential subject's capacity to
				consent. The IRB and/or the chief executive officer may require parties other
				than the researcher to assess a participant's capacity to consent. If there is
				a doubt about a participant's capacity to give informed consent in relation to
				a specific research project which involves no more than minimal risk, an
				assessment of capacity to consent shall be made by the chief executive officer
				of the facility or his or her designee.
(b) If a participant lacks the capacity to
				consent, and the research involves no more than minimal risk, consent may be
				obtained from a party authorized under clause (a)(3)(iii)(
b
)
				of this section. In the absence of a party from this list, consent may be
				obtained from a court of competent jurisdiction or from a party recommended by
				the IRB and appointed by the facility or entity's (see glossary) governing body
				(by whatever title known), for the purpose of acting as a surrogate in the
				consent process on behalf of a person who lacks the capacity to consent.
(1) This party shall have no interest that
				conflicts with the interest of the person being represented and shall have
				knowledge and skills that insure adequate representation of the
				person.
(2) The party appointed by
				the governing body shall not be associated in any way (except in this role or
				as a non-affiliated member of the IRB) with the research, the researcher(s) or
				the facility or entity.
(iii) Research involving more than minimal
				risk.
(a) For research which involves more
				than minimal risk, the assessment of a person's capacity to consent (see
				glossary) to a particular research project shall be made by the person's
				program planning team, in consultation with the researcher. If doubt exists
				about the person's capacity to consent, the following provisions shall apply:
(1) The chief executive officer of a facility
				or entity shall obtain, from a consultant, an independent written opinion and
				analysis of a person's capacity to give or withhold informed consent to
				participate in the research project. The consultant shall be a New York State
				licensed psychologist or physician, or a psychiatrist holding appropriate
				licensure in New York State; have experience in treating persons with
				developmental disabilities; and shall not be an employee of the facility or
				entity.
(2) After considering the
				opinions of the consultant, the program planning team, and the researcher, the
				chief executive officer shall then determine whether the participant lacks the
				capacity to consent.
(3) The
				opinions of the program planning team, the researcher and the consultant,
				together with the chief executive officer's decision, shall be documented in
				the person's clinical record. The chief executive officer's decision shall be
				communicated to the person and his/her parent, other nearest relative, guardian
				or correspondent.
(b)
				For research which involves more than minimal risk, if a person lacks the
				capacity to consent to participation, informed consent may be obtained from a
				person's court appointed guardian who is legally empowered to give consent to
				research; or an actively involved (see glossary) spouse, parent, adult child,
				or other actively involved adult family member (see glossary). Consent shall be
				sought from the parties on this list in the order stated. If the first
				available party on this list objects or if no party from the list is available
				or willing to give consent, application may be made to a court of competent
				jurisdiction.
(4) Informed consent for minors.
(i) All research.
(a) If a participant is under 18 years of
				age, informed consent shall be obtained from a parent, legal guardian, or
				actively involved family member. A participant under the age of 18 who is
				married or the parent of a child shall, for the purposes of this section, be
				considered an adult, and the provisions of paragraph (3) of this subdivision
				shall apply. If no parent, legal guardian, or actively involved family member
				is available, consent may be obtained from:
(1) a party appointed in conformance with
				clause (ii)(
a
) of this paragraph; or
(2) a court of competent
				jurisdiction.
(b) The
				assent (see glossary) of participants under 18 years of age must be obtained,
				and shall be sought and documented in a manner approved by the IRB. This shall
				be in addition to the informed consent required pursuant to paragraph (3) of
				this subdivision. When practicable the assent should be in writing. However,
				the IRB may waive the requirement to obtain the assent of a minor if the
				capacity of the child to assent is so limited that he or she cannot reasonably
				be consulted. The waiver may be granted for a category of minors if, as a
				group, their age or other characteristics indicate that they uniformly lack
				sufficient capacity to assent.
(c)
				A minor's objection to participation in a research project must be honored,
				except when:
(1) a surrogate party, specified
				in clause (4)(i)(
a
) of this subdivision consents;
				and
(2) the child's program
				planning team finds and documents:
(i) that
				the intervention or procedure involved in the research is necessary treatment;
				and
(ii) that the intervention or
				procedure involved in the research is available only in the context of the
				research; and
(iii) that the
				intervention or procedure involved in the research holds out a prospect of
				direct benefit that is important to the health or well-being of the
				minor.
(ii) Research involving no more than minimal
				risk.
(a) If the research involves no more
				than minimal risk, and a parent or legal guardian is not available, informed
				consent may be obtained from a party recommended by the IRB and appointed by
				the facility or entity's governing body (by whatever title known), for the
				purpose of acting as a surrogate in the consent process by giving or
				withholding consent to participation in a research project, on behalf of a
				minor.
(1) This party shall have no interest
				that conflicts with the interest of the minor being represented, and shall have
				knowledge and skills that insure adequate representation of the
				minor.
(2) The party appointed by
				the governing body shall not be associated in any way (except in this role or
				as a nonaffiliated member of the IRB) with the research, the researcher(s) or
				the facility or entity.