References

Research with children involves more complex considerations with respect to assuring the voluntary participation of research participants than research with adults. As described below, there are issues of assent, consent, and parental permissions that must be considered. Federal regulations do not provide many specifics but they do include parental permission requirements, also discussed below. The Federal regulations also charge that “adequate provisions [be] made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent…[taking] into account the ages, maturity, and psychological state of the children involved ” [45 CFR 46.408]. How Does Assent Differ from Consent? Though children do not have the legal capacity to “consent ” to participate in research, they should be involved in the process if they are able to “assent ” by having a study explained to them and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to participate or not. They may also provide a written assent if they are older. Circumstances in which a child's assent may be unnecessary or inappropriate are discussed below under Waiver of Child’s Assent