Children are persons who have not attained the legal age for consent to treatments or procedures involved in research; in New York State anyone under the age of 18 is considered a child. When children are involved in a research activity it is necessary to obtain their assent and the permission of their parents. Assent is defined as a child's affirmative agreement to participate in research. This gives a child the opportunity to decide if they want to take part, and to decline if they are not interested. In these cases, an Assent Form is prepared and the procedure is very similar to that of obtaining consent with an adult. The Investigator provides the form to the child and, depending on the child's reading ability and comprehension, can read it to or with the child. The child is given the opportunity to ask questions and the Investigator takes the opportunity to explain anything that is not clear.
The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve.
In addition to obtaining the assent of a child participant, it is necessary to have parental permission. This gives a parent or guardian the opportunity to learn about the study, ask questions, and agree or decline their child’s participation in the research study. Investigators should follow the Basic Elements of a Consent Form when preparing a Parental Consent Form except that the form is written for the parents so it will reference "your child" instead of "you". Please contact the HSRO for additional guidance.
Under certain circumstances an IRB may waive the requirements for obtaining parental or guardian permission. If the IRB determines that a research activity is designed to study conditions in children for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the parental permission requirements provided that an appropriate mechanism is in place to protect the children, and provided that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting the children would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition.