the informed consent process, the assent process is intended to be an ongoing,
interactive conversation between the research team and the child, young adult,
or adult lacking the capacity to give informed consent. The assent process is
not about getting the participant "to sign on the dotted line";
rather, it is about making sure they understand the research and what it means
to participate. By engaging participants in understanding the research project,
regardless of age or capacity for informed consent, health care providers and participants
may become "partners" in the project. Children and adults are likely
to feel more in control and more involved in the research as a result.
Child Assent: When children are included as
research subjects, their assent must generally be obtained. See IRB
Guidance For Investigators on Consent for Protocols Involving Children and
Consenting Minors (pdf) and Additional Protections for Inclusion of Children in
Research - OHRP (pdf) and FDA (pdf).
Adult Assent: When adults who lack the capacity to give
informed consent are included as research subjects, the IRB may be required to
consider whether the study requires procedures for obtaining assent. See Adult Assent Process (Word doc).