Miller Victoria A, Feudtner Chris
Assistant Professor of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Professor of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
IRB. 2016 Jul-Aug;38(4):1-7.
The primary objective of this study was to describe parents' and children's perceptions of the health benefits of research participation. We assessed 180 children ages 8 to 17 years who recently enrolled in medical research and their parents. Of the 136 parents with children on observational protocols, 41% indicated that there would be a health benefit to the child. Their descriptions of benefits revealed that many envisioned a future health benefit to the child arising from improvements in treatment due to the research. There was no difference in ratings of likelihood or importance of benefit between parents of children enrolled in observational protocols versus interventional protocols. Children enrolled in observational protocols were more likely to respond "don't know" to the question about potential health benefit compared to children on interventional protocols. For both observational and interventional protocols, the informed consent process may be enhanced when research personnel explicitly differentiate between different types of potential benefits, including heretofore-unrecognized future direct health benefits.
本研究的主要目的是描述父母和孩子对参与研究的健康益处的看法。我们评估了180名最近参与医学研究的8至17岁儿童及其父母。在136名孩子参与观察性研究方案的父母中，41%表示孩子会从中获得健康益处。他们对益处的描述显示，许多人设想研究带来的治疗改善会给孩子带来未来的健康益处。参与观察性研究方案的孩子的父母与参与干预性研究方案的孩子的父母在益处可能性或重要性的评分上没有差异。与参与干预性研究方案的孩子相比，参与观察性研究方案的孩子更有可能对潜在健康益处的问题回答“不知道”。对于观察性和干预性研究方案，当研究人员明确区分不同类型的潜在益处，包括迄今为止未被认识到的未来直接健康益处时，知情同意过程可能会得到加强。
