Implementing the Assent Requirement for Research With Children

Trial Information

Implementing the Assent Requirement for Research With Children

One of the principal safeguards mandated by the Federal Regulations governing clinical
research with children is the assent requirement: children who are capable must provide an
affirmative agreement to participate unless the research "holds out a prospect of direct
benefit that is important to the health or well-being of the children and is available only
in the context of the research" (46.408). Despite the importance of the assent requirement,
the Federal regulations offer no guidelines on its implementation. In the present study, we
propose to survey children and one of their parents in order to obtain information
concerning children's role in making decisions concerning their participation in clinical
research. Five elements of children's involvement in the decision-making process with
respect to their participation in clinical research will be assessed: 1) receipt of
information concerning the available options; 2) understanding of this information; 3)
assessment of the available options; 4) expression of a preferred option; and 5)
coordination with parental decision-making.

Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in,
or is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs
where the minor is participating in, or is in follow-up for, a drug treatment research study
for asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care
for asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400
subject pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved
in clinical care for asthma, with approximate balance between the sites. Two formalized
survey instruments - research/clinical minor, research/clinical parent - will be developed
in consultation with Research Triangle Institute (RTI).