1. (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. (2) Requirements for conducting research in facilities operated or certified by OPWDD involving persons with developmental disabilities.

   1. (i) All research.

      1. (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. (1) Initial and updated assurances shall be submitted at times specified by the commissioner.
         2. (2) No research may be initiated unless a current approved assurance is on file with the commissioner.
         3. (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. (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:

            1. (i) the Department of State, Division of Information Services, 11th Floor, 41 State Street, Albany, NY 12207; and
            2. (ii) the Office for People With Developmental Disabilities, Attention: Public Access Officer, 44 Holland Avenue, Albany, NY 12229.

      2. (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. (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. (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. (3) Participants may only take part in research which does not come into substantive conflict with their individual plan of services.
         4. (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. (5) All research proposals shal be reviewed and approved by the chief executive officer of the facility responsible for the participant(s).
         6. (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. (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. (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. (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.
      3. (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.

   2. (ii) Research involving more than minimal risk (see glossary).

      1. (a) Informed consent shall always be obtained in conformance with paragraphs (3) and (4) of this subdivision.
      2. (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.
      3. (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.
      4. (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. (3) Informed consent requirements by or for adult persons in facilities.

   1. (i) All research.

      1. (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.
      2. (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.
      3. (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.
      4. (d) No capable participant shall become or remain a research subject over his or her objection.
      5. (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.
      6. (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.

   2. (ii) Research involving no more than minimal risk.

      1. (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.

      2. (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. (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. (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.

   3. (iii) Research involving more than minimal risk.

      1. (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. (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. (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. (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.
      2. (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. (4) Informed consent for minors.

   1. (i) All research.

      1. (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. (1) a party appointed in conformance with clause (ii)(a) of this paragraph; or
         2. (2) a court of competent jurisdiction.
      2. (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.

      3. (c) A minor's objection to participation in a research project must be honored, except when:

         1. (1) a surrogate party, specified in clause (4)(i)(a) of this subdivision consents; and

         2. (2) the child's program planning team finds and documents:

            1. (i) that the intervention or procedure involved in the research is necessary treatment; and
            2. (ii) that the intervention or procedure involved in the research is available only in the context of the research; and
            3. (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.

   2. (ii) Research involving no more than minimal risk.

      1. (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. (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. (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.

            (b) Standards of certification.

5. (1) If the facility has participated or is participating in a research project in which the researcher accessed clinical records only, and had no contact with persons in the facility, there is project specific documentation that:

   1. (i) The facility or entity conducting the research has a Federal or OPWDD approved assurance of compliance with regulations for the protection of human subjects.
   2. (ii) The commissioner authorized access to clinical records.
   3. (iii) There is a current institutional review board approval.
   4. (iv) There is a current approval from the chief executive officer.

6. (2) If the facility has participated or is participating in a research project which involved more than access to clinical records, there is project specific documentation that:

   1. (i) The facility or entity conducting the research has a Federal or OPWDD approved assurance of compliance with regulations for the protection of human subjects.
   2. (ii) There is a current institutional review board approval.
   3. (iii) There is a current approval from the chief executive officer.
   4. (iv) Unless there is a waiver of informed consent or a waiver of the need to document consent, written informed consent was obtained for each person participating in the research project.

(a) Principles of compliance.