Assessing The Assent Process In Pediatric Research

管理儿童临床研究的联邦条例规定的主要保障措施之一是同意要求：有能力的儿童必须提供“肯定同意”才能参与，除非研究“具有对儿童健康或福祉至关重要的直接益处的前景，并且只有在研究的背景下才能获得”（46.408）。尽管同意要求很重要，但《联邦条例》没有提供执行该要求的指导方针。最重要的是，与获得同意的联邦条例不同，没有要求在征求儿童同意之前必须提供哪些信息。同样，《联邦条例》也没有就征求儿童同意与获得父母许可的要求如何协调提供任何指导。在本研究中，我们建议调查参加临床研究的儿童和他们的父母之一，以获得有关儿童的作用，在决策有关他们参与临床研究的信息。本研究获得了NICHD IRB和杜克大学IRB的批准。我们目前正在进行面试。

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.