Assessing The Assent Process In Pediatric Research

关于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参与的“肯定同意”，除非研究“对儿童的健康或福祉具有重要的直接利益前景，并且只能在研究范围内获得”（46.408）。尽管同意要求很重要，但《联邦条例》并未就其实施提供指导方针。最重要的是，与关于征得同意的联邦条例不同，没有规定在征得儿童同意之前必须向他们提供哪些信息。同样，《联邦条例》也没有就如何协调征求儿童同意与获得父母许可的要求提供任何指导。在本研究中，我们建议对参加临床研究的儿童和他们的一位父母进行调查，以了解儿童在参与临床研究的决策中所起的作用。本研究已获得NICHD IRB和杜克大学IRB的批准。我们目前正在进行试前访谈。

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.