Cheah Phaik Yeong, Parker Michael
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, UK Nuffield Department of Population Health, The Ethox Centre, University of Oxford, Oxford, UK.
Nuffield Department of Population Health, The Ethox Centre, University of Oxford, Oxford, UK.
Arch Dis Child. 2015 May;100(5):438-40. doi: 10.1136/archdischild-2014-307121. Epub 2014 Dec 4.
Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. These populations are under-represented in all types of clinical research. We propose that, for research with a prospect of direct benefit that has been approved by relevant ethics committees, the default position should be that minors who are able to provide valid consent and meet the following criteria should be able to consent for themselves regardless of age and whether they have reached majority: the minor must be competent and mature relative to the decision; their consent must be voluntary and they must be relatively independent and used to decision making of comparable complexity. In addition, the context must be appropriate, the information related to the research must be provided in a manner accessible to the minor and the consent must be obtained by a trained consent taker in surroundings conducive for decision making by the minor. In this paper, we have argued that consent by mature minors to research participation is acceptable in some situations and should be allowed.
权威的国际准则规定，未成年人参与研究必须征得其父母或监护人的同意。目前，大量成熟的未成年人，尤其是在低收入环境中，被排除在研究参与之外，原因是他们的父母无法联系或拒绝提供同意，尽管他们可能愿意参与，而且此类研究有可能带来实际益处。在各类临床研究中，这些人群的代表性不足。我们建议，对于经相关伦理委员会批准的、有望带来直接益处的研究，默认立场应该是，能够提供有效同意并符合以下标准的未成年人，无论其年龄大小以及是否已成年，都应能够自行同意：未成年人在决策方面必须具备能力且成熟；其同意必须是自愿的，并且他们必须相对独立且习惯于进行类似复杂程度的决策。此外，环境必须适宜，与研究相关的信息必须以未成年人能够理解的方式提供，并且同意必须由经过培训的同意获取者在有利于未成年人决策的环境中获得。在本文中，我们认为成熟未成年人同意参与研究在某些情况下是可以接受的，应该予以允许。
