Westra Anna Eva, de Beaufort Inez
Department of Medical Ethics and Philosophy of Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.
J Med Ethics. 2015 Mar;41(3):278-80. doi: 10.1136/medethics-2013-101496. Epub 2013 Sep 6.
Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the research subjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden.
涉及儿童或其他被认为无法提供知情同意的无行为能力受试者的研究很复杂，尤其是在研究不能直接使研究受试者自身受益的情况下。因此，世界医学协会关于研究伦理的标志性文件《赫尔辛基宣言》指出，无行为能力的研究受试者不得纳入此类研究，除非该研究仅带来最小风险和最小负担。在本文中，我们认为，鉴于对这些群体的研究预计会扩大，这种不加区分的最小风险和负担要求已不再足够。在即将到来的《宣言》修订中，相关段落应加以完善，使其既不会过度限制，也不会在伦理上不合理地宽松。我们的第一个建议是，促使研究伦理委员会更准确地识别研究受试者仅因研究目的而必须承受的那些风险和负担，方法是区分两种研究程序类型，而不是两种研究类型。我们的第二个建议是，对于涉及能够同意参与研究且风险和/或负担至多比最小风险和负担略有增加的受试者的极具价值的研究，允许有例外情况，不受最小风险和负担要求的限制。
