Agreement to participate in proposed research, given by an individual not competent to give legally valid informed consent (e.g., a child or mentally limited person). Mere failure to object may not be construed as assent.
- Assent means a child's affirmative agreement (verbal or written) to participate in a clinical investigation. Children age 10 and up are generally able to provide their assent.
- Assent is an adult's affirmative agreement (verbal or written) to participate in a clinical investigation. Adults may be assented (instead of consent) if they have a cognitive disability rendering them unable to consent for themselves. Steps should be in place to assure that all participants are given the opportunity to consent or assent.