IRB Manual
      7.3 Research Involving Children
   

OPWDD (14 NYCRR 633.13) has issued regulations governing research involving children. According to our Assurance of Compliance, these regulations should be applied to all research involving children, not just research sponsored by or funded by DHHS.

These requirements have been integrated with the federal requirements below. OMH defines a patient under the age of 18 who is on voluntary status on his own application, or who is married or the parent of a child as an adult for the purpose of providing consent to research participation. OPWDD defines a participant who is under the age of eighteen who is married or the parent of a child as an adult for the purpose of providing consent to research participation.

The exemption found in 45 CFR 46.101(b)(2) for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.


  7.3.1 Research Which Does Not Involve Greater Than Minimal Risk
   

This research may be approved if the IRB determines that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

  7.3.2 Research Involving Greater Than Minimal Risk But Presenting The Prospect of Direct Benefit to the Individual Subjects
   
This research may be approved if the IRB determines that:
  1. the risk is justified by the anticipated benefit to the subjects;
  2. the ratio of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available approaches; and
  3. adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

  7.3.3 Research Involving Greater Than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, But Likely to Yield Generalizable Knowledge About the Subject's Disorder or Condition
   
This research may be approved if the IRB determines that:
  1. the risk represents a minor increase over minimal risk;
  2. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations;
  3. the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the subject's disorder or condition; and
  4. adequate provisions are made for assent of the children and permission of their parents or guardians.

7.3.4 Research Not Otherwise Approvable Which Presents An Opportunity To Understand, Prevent or Alleviate A Serious Problem Affecting The Health or Welfare of Children
   
This research may be approved if the IRB determines that:
  1. the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
  2. the research will be conducted in accordance with basic ethical principles (i.e., the Belmont Report, Appendix C); and
  3. adequate provisions are made for soliciting the assent of children and the permission of their parent or guardians.
For research funded by the Department of Health & Human Services (NIH, etc.) the three determinations listed above must also be made by the Secretary DHHS after consultation with a panel of experts.

7.3.5 Requirements For Permission By Parents or Guardians and For Assent By Children
   

The IRB must ensure that adequate provisions are made for soliciting the assent of children when, in the judgment of the Board, the children are capable of doing so. The IRB should take into account the age, maturity and psychological state of the children. This judgment may be made for all children under a particular research protocol or on a more individualized basis as the IRB deems appropriate.

If the IRB determines that the capacity of some or all of the children is so limited that they cannot reasonably be consulted or 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 children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement in accordance with the general regulations on waiver of elements of informed consent (p. 18-19).

OMH Consent may be given by a parent or legal guardian. If no parent or legal guardian is available, consent may be obtained from an adult family member who is involved in making treatment decisions for the child, or from a court of competent jurisdiction.

OPWDD Consent may be given by a parent, guardian, or actively involved family member. If none of these are available consent may be obtained from a court of competent jurisdiction or, if the research involves no more than minimal risk, from a party recommended by the IRB and appointed by the facility or entity's governing body. 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. The party 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.

For research not involving greater than minimal risk and research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects, the IRB may find that the permission of one parent is sufficient. In doing so, the IRB must take into account such factors as the nature of the research and the age, maturity, status and condition of the subjects.

For all other research involving children, when permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, not reasonably available, or the child belongs to a single parent family (i.e., when only one parent has legal responsibility for the care and custody of the child).

When the IRB determines that the assent of the child is required, it shall also determine whether and how assent must be documented.


7.3.6 Objection to Participation by Children
   

OMH A child's objection to participation in a research project must be honored, except when a child psychiatrist who is neither employed by the facility nor associated with the research, finds and documents 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 of the child and is available only in the context of the research. This requirement is in addition to the requirement for the consent of a parent, guardian, or if no parent or guardian is available, from an adult family member who is involved in making health care decisions for the child or a court of competent jurisdiction. If a decision is made to treat a minor patient, in the context of a research project, over the objection of the minor, and the treatment is not emergency treatment, MHLS shall be notified and the treatment will be delayed for 4 calendar days. If, within that period, MHLS files a legal action on behalf of the patient challenging the determination of the independent child psychiatrist, the treatment may be administered 3 calendar days thereafter, unless a court orders otherwise.

OPWDD A minor's objection to participation in research must be honored except when an authorized surrogate consents and the child's program planning team finds and documents:
  1. that the intervention or procedure involved in the research is necessary treatment; and
  2. that the intervention or procedure involved in the research is available only in the context of the research; and
  3. 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.

7.3.7 Waiver of Parental or Guardian Permission
   
If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (e.g., neglected or abused children), it may waive the consent requirements provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided that the waiver is not inconsistent with State or local law. (OMH:  Waivers, and the specific protective mechanism must be approved by the Commissioner.) (OPWDD Does not provide for a waiver of parental/guardian consent. For some research involving no more than minimal risk a surrogate appointed by the Governing Body may consent - see 7.3.5). The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status and condition.

Protective mechanisms should generally include the appointment of an advocate, by the IRB, for each child. If possible, this person should be someone that the child knows and trusts e.g. a member of the treatment team. The advocate should support the child in asking questions about the research and should ensure that the child understands that he/she does not have to participate, can withdraw once participation commences and will not suffer any penalty or loss of benefits for doing so. The advocate should agree to take on this role, in writing, and should certify that he/she does not have any interests which conflict with this role.

In general, minors may only participate in research if the consent of a parent(s) or guardian has been obtained or a court order authorizing the child's participation in research has been obtained. IRBs may want to consult one of the department's attorneys before approving a waiver of parental or guardian permission.


7.3.8 Wards
   
Children who are wards of the State or any other agency, institution or entity can be included in research approved under section D or E, listed above, only if the research is:
  1. related to their status as wards: or
  2. conducted in schools, camps or similar group settings in which the majority of children involved as subjects are not wards.

   
The IRB shall require the appointment of an advocate for each child, in addition to any other individual acting as guardian or in loco parentis for the child. One individual may serve as an advocate for more than one child.

The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s) or the guardian organization.
     
   


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