Children must provide assent to participation when, in the judgment of the HSRB the children are capable of providing assent. 

  • Children are defined in the U.S. Department of Health and Human Services regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted" 45 CFR §46.402(a). 
  • Assent is defined as the voluntary "affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent" 45 CFR §46.402(b).

In determining whether children are capable of assenting, the HSRB will take into account the age, maturity, and psychological state(s) of the children, either individually or as a group. Children under age 8 may give assent orally or, in cases involving infants or very young children, by the act of participating. Children who can read (those 8-18 years old) should provide assent by signing a written form unless HSRB approves a different process.

In addition to the assent of the children, regulations require legally effective informed consent from the parent(s) (the child's biological or adoptive parent) or the legally appointed guardian (authorized under applicable State or local law to consent on behalf of a child) of all children who are participants in research. The consent of just one parent is allowed if the research presents no greater than minimal risks or if it holds out the prospect of providing direct benefits to the child. If the research presents greater than minimal risks and no prospect of direct benefit to the individual child, the consent of both parents is required, unless one parent is deceased, unknown, incompetent, not a legal custodian, or not reasonably available.