Research ethics committee decision-making in relation to an efficient neonatal trial
Research ethics committee decision-making in relation to an efficient neonatal trial
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DOI：
10.1136/archdischild-2016-310935
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发表时间：
2017-07-01
影响因子：
4.4
通讯作者：
Modi, N.
中科院分区：
文献类型：
--
作者：
Gale, C.;Hyde, M. J.;Modi, N.
随机对照试验是一种减少临床实践不确定性的黄金标准方法，其成本正在上升，招募速度往往较慢。我们确定了促进大型、高效临床试验的方法学方法是否为英国研究伦理委员会（rec）所接受。设计我们与父母合作制定了一项方案，用于比较两种广泛使用的早产儿输血方法的比较有效性，随机对照试验。我们采用了四种方法来提高招募和效率：(i)使用电子患者记录进行患者识别、随机化和数据采集的护理点设计；（ii）简短的两页信息表；（iii）明确提及可能的纳入福利；（iv）选择退出同意（默认为注册）。在英国健康研究管理局的支持下，我们向12个英国rec提交了一份相同的方案。评议委员会提出赞成意见的数目。结果所有医院均可接受电子病历的使用；一个REC对简短的家长信息表提出了担忧，10个关于纳入福利，9个关于选择退出同意。在回应查询后，九间评审委员会给予赞成的最终意见，而三间评审委员会则因认为退出同意程序无效而拒绝申请。本研究中的大多数rec认为，在新生儿比较有效性研究中，使用电子病历数据、简短的信息表、选择退出同意和提及可能的纳入获益是可以接受的。我们认为有必要为RECs提供有关选择退出同意程序的指导。这些方法为大型随机对照试验提供了便利。
Objective Randomised controlled trials, a gold standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs).Design We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC.Setting RECs in the UK.Main outcome Number of REC granting favourable opinions.Results The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid.Conclusions A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials.