DESCRIPTION OF REQUIREMENTS FOR RESEARCH INVOLVING CHILDREN

Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally unable to give valid consent. Special procedures and consideration are, therefore, required by Federal regulations for the review of research involving children.

Whenever feasible, appropriate studies should be conducted on adults and older children before young children are involved as research subjects.

Research involving children will not be considered exempt unless it involves only the “observation of public behavior when the investigator(s) do not participate in the activities observed” (Sec. 401(b)). Therefore, in most cases researchers should use the Expedited/Full submission form.

Risk Assessment:

Federal regulations permit the IRB to approve research involving children who will not directly benefit from the study only if the research is either of minimal risk (for any child) or a minor increase over minimal risk (for a child with the condition being studied). Therefore, research involving children must fall within one of the following three categories (45 CFR 46 Subpart D).

1. Research presenting no more than minimal risk.  The level of risk that a child may be exposed to by interventions and/or procedures that do not offer the prospect of direct benefit is restricted to the level of risk that a child may be exposed to in the course of a child’s everyday life or during routine examinations.
2. Research involving an intervention/procedure with more than minimal risk but offers the “prospect of direct benefit” or may “contribute to the ….well being of the individual child. The IRB may approve studies that offer the prospect of direct benefit to the child and presents greater than minimal risk only if a) the risk is justified by the anticipated benefits to the participant and b) the relationship of the anticipated benefit to the risk is at least as favorable to the participant as that presented by available alternative approaches.
3. Research involving an intervention/procedure that presents only a “minor increase over minimal risk” yet does not offer any prospect of direct benefit or contribute to the well being of the child. The IRB may approve these studies only if: a) the risk represents only a minor increase over minimal risk, b) the intervention/procedure presents experiences that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations, c) the intervention/procedure is likely to yield generalizable knowledge about the participants’ disorder or condition, which is of vital importance for the understanding or amelioration of the participant’s disorder or condition.

Consent:

The IRB's policy with respect to obtaining consent from the parents or guardians and the assent of the minor child are specified below:

1.    In most cases, parental consent must be obtained if the research involves minors under the age of 18. A written consent form must be used to document informed consent. The IRB may waive parental permission if obtaining permission is not a reasonable requirement to protect the child (e.g., neglected or abused children), provided an appropriate mechanism for protecting the children who will participate is substituted. Consent forms, written in lay terminology must be included with the IRB submission.

2.    Assent is defined as “a child’s affirmative agreement to participate in research.” However, the mere absence of an objection by the child should not be construed as assent. Assent must be obtained from the children who participate in research unless they are not capable of understanding what is being asked of them. Researchers must submit an assent protocol with their IRB submission. This protocol will document what the minor children research participants will be told about the study and their participation in the study. The form should include a simplified version of the elements of informed consent described in the instructions for documentation of informed consent. Note that the child should be given an explanation of the general purpose of the research, the procedures to be used, and their meaning in terms of discomfort and inconvenience at a level appropriate to the child's age, maturity and condition. Generally speaking, investigators should seek verbal assent from children as appropriate to their age, maturity and psychological state. The assent process fosters an element of understanding, cooperation and feeling of inclusion on the part of the child while demonstrating the investigator’s respect for the rights and dignity of the child in the context of research.

In certain circumstances, the IRB may waive the requirement to obtain the assent of a child subject. For example:

• The child is not cognitively able to understand what is being asked of him/her; or
• The research offers the prospect of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research. Here, the parents’ right to make medical decisions for their child may come into conflict with the child’s right to give or withhold assent. In this situation, the IRB can waive the requirement for assent, but the child should be appropriately informed about the study; or
• Even where the IRB determines that the children are capable of assenting, the IRB may waive the requirement for obtaining assent. When requesting a waiver of assent, justification and measures to protect the child should be described.