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. Most importantly, unlike the Federal Regulations for obtaining consent, there are no requirements concerning what information children must be given prior to soliciting their assent. Similarly, the Federal Regulations do not provide any guidance on how the solicitation of children's assent should be coordinated with the requirement to obtain parent(s) permission. In the present study, we propose to survey children enrolled in clinical research and one of their parents in order to obtain information concerning children's role in making decisions concerning their participation in clinical research. This study was approved by the NICHD IRB and the Duke University IRB. We are currently conducting pretest interviews.
|Wendler, David; Jenkins, Tammara (2008) Children's and their parents'views on facing research risks for the benefit of others. Arch Pediatr Adolesc Med 162:9-14|