Sammons H M, Malhotra J, Choonara I, Sitar D S, Matsui D, Rieder M J
Academic Division of Child Health, University of Nottingham, Medical School, Derbyshire Children's Hospital, Uttoxeter Road, Derby, DE22 3DT, UK.
Eur J Clin Pharmacol. 2007 May;63(5):431-6. doi: 10.1007/s00228-007-0281-9. Epub 2007 Mar 16.
Ethical problems are quoted as a reason not to perform clinical trials in children. Little is known about the views of researchers regarding ethics.
A pilot study was conducted to assess the applicability of a questionnaire design containing trial scenarios to examine views regarding the use of children in drug trials and to elicit possible international differences.
Paediatricians and researchers in the United Kingdom and Canada.
Responders were presented with a questionnaire containing direct questions and six trial scenarios, each containing an ethical dilemma. Responders were asked regarding their own approval and their perceived opinion of whether an ethical review board (ERB) would approve.
One hundred questionnaires (50 each country) were received. Few responders had research ethics training (14% United Kingdom and 8% Canada). Most (80 and 88%) felt children could be harmed by participation in trials and half (47 and 59%) felt children should only participate if they receive direct benefit. Many (58 and 61%) disagreed with payments beyond travel expenses. In the trial scenarios, 34% of responders were willing to enter healthy children in a pharmacokinetics study of an antibiotic for cystic fibrosis and 22% considered their ERBs would approve. Only a third (33%) would enter children in an analgesia trial that was placebo-controlled.
Using healthy children and placebos in trials caused concern. Similar views were found between the two countries. The majority had no training in research ethics. The study highlights the usefulness of a questionnaire with clinical trial scenarios to try to elicit views on the ethics of conducting research in children.
伦理问题被视为不开展儿童临床试验的一个理由。对于研究人员在伦理方面的观点，我们知之甚少。
开展一项试点研究，以评估包含试验场景的问卷设计在考察药物试验中使用儿童的观点以及揭示可能存在的国际差异方面的适用性。
英国和加拿大的儿科医生及研究人员。
向受访者发放一份包含直接问题和六个试验场景的问卷，每个场景都包含一个伦理困境。询问受访者自己是否批准以及他们认为伦理审查委员会（ERB）是否会批准。
共收到100份问卷（每个国家50份）。很少有受访者接受过研究伦理培训（英国为14%，加拿大为8%）。大多数人（80%和88%）认为儿童参与试验可能会受到伤害，一半人（47%和59%）认为儿童只有在能直接受益时才应参与。许多人（58%和61%）不同意除差旅费之外给予报酬。在试验场景中，34%的受访者愿意让健康儿童参与一项针对囊性纤维化的抗生素的药代动力学研究，22%的人认为他们的伦理审查委员会会批准。只有三分之一（33%）的人会让儿童参与一项安慰剂对照的镇痛试验。
在试验中使用健康儿童和安慰剂引发了关注。两国的观点相似。大多数人没有接受过研究伦理培训。该研究凸显了包含临床试验场景的问卷在试图引出关于儿童研究伦理观点方面的有用性。
