Research Involving Children

Children are more vulnerable as research participants due to their limited capacity to understand and make responsible decisions concerning participation. Therefore, special caution is required in the preparation and review of protocols involving children as subjects [cfr46.401-409].

Obtaining parental permission/child assent

Written permission from the parent or guardian is required for a child to participate in research, including surveys and interviews, unless otherwise determined by HSRP. HSRP makes the final determination of approved assent/permission procedures.

A child cannot provide legal consent to participate in research. Provisions should be made by the PI to obtain assent from all children who are capable.  Assent means a child’s affirmative agreement to be in the study.  Failure to object is not considered assent.  Children have the right to refuse to participate.

Assent is to be obtained from the child unless there is a clear, written justification for not obtaining assent, e.g., age, maturity, psychological state.

Assent may be oral if the PI provides sufficient explanation that written assent is not feasible.

Judgments about the capability of providing assent may be made for each child or for all the children.  This must be clearly specified.

There must be a clear means of documenting how assent is obtained, and by whom. When appropriate, a separate assent form should be drafted with language appropriate to the child's developmental level.

Explanation of and process for quitting or withdrawal from the research

Since children tend to be acquiescent to adult wishes and are often reluctant to speak up when uncomfortable, special attention must be given to processes for quitting or withdrawal from research.  Along with the usual statements in the informed consent, the researcher is advised to:

  • Be cognizant of signs of discomfort shown by the child throughout the interview or testing procedures and periodically inquire about the child's reactions or feelings.
  • Include procedures for withdrawal that address the above considerations.