Research consent from young people in resource-poor settings.
Research consent from young people in resource-poor settings.
复制标题
DOI：
10.1136/archdischild-2014-307121
复制
发表时间：
2015-05
影响因子：
5.2
通讯作者：
Parker M
中科院分区：
文献类型：
--
作者：
Cheah PY;Parker M
权威的国际准则规定，未成年人参与研究，必须得到其父母或监护人的同意。大量成年未成年人，特别是低收入环境中的未成年人，目前被排除在研究参与之外，因为他们的父母不在或拒绝提供同意，尽管他们可能希望这样做，而且这种研究有可能带来真实的好处。这些人群在所有类型的临床研究中代表性不足。我们建议，对于已获得相关伦理委员会批准的具有直接受益前景的研究，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应该能够自己同意，而无论年龄和是否已成年：未成年人必须有能力并成熟地做出决定;他们的同意必须是自愿的，他们必须相对独立，并习惯于作出类似复杂性的决策。此外，背景必须适当，与研究有关的信息必须以未成年人可以获得的方式提供，同意必须由受过培训的同意者在有利于未成年人作出决定的环境中获得。在本文中，我们认为，同意由成熟的未成年人参与研究是可以接受的，在某些情况下，应该被允许。
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.
登录
查看更多内容
影响因子：
5.2
作者：
Baines, Paul
通讯作者：
Baines, Paul
影响因子：
2.7
作者：
Cheah PY;Parker M
通讯作者：
Parker M
影响因子：
5.2
作者：
Modi, Neena;Vohra, Jyotsna;Greenough, Anne
通讯作者：
Greenough, Anne
影响因子：
3.5
作者：
Dowse, Ros;Ramela, Thato;Browne, Sara H.
通讯作者：
Browne, Sara H.
影响因子：
4.1
作者：
KOREN, G;CARMELI, DB;HASLAM, R
通讯作者：
HASLAM, R