Children

Category: Research Subjects

Are there special considerations when children are the research subjects?

Yes. For many procedures, persons under the age of 18 years are not of legal age to provide informed consent. For these procedures, signed consent must be obtained by a parent or legal guardian. Federal regulations define "parent" as the child's biological or adoptive parent and "guardian" as an individual authorized by the state or local law to consent on behalf of the child. In addition to signed consent from the parent or guardian, researchers should also seek assent from the child when possible. "Assent" is defined as the child's affirmative agreement to participate in the research, and should not be construed to mean a lack of resistance to participation. Very young children or children with cognitive impairments may not be able to provide assent. Due to the vulnerable nature of children, the IRB must review all proposals in which children are involved as subjects. However, some types of research with children are exempt from IRB review and oversight as described in Subpart A, 46.101 of the Common Rule. Typically, this type of research is conducted in established or commonly accepted educational settings involving normal educational practices or exploring educational tests.