Slowther Anne, Boynton Petra, Shaw Sara
Ethox Centre Department of Public Health and Primary Care, University of Oxford, Oxford OX3 7LF.
J R Soc Med. 2006 Feb;99(2):65-72. doi: 10.1177/014107680609900218.
Healthcare research is haunted by a history of unethical studies in which profound harm was caused to vulnerable individuals. Official systems for gaining ethical approval for research, designed to prevent a repetition of these shameful examples, can prove bureaucratic and inflexible in practice. The core ethical principles of respect for autonomy, prevention of harm, promotion of benefit, and justice (which form the basis of professional codes of research conduct) must be applied flexibly to take account of contextual, methodological, personal and practical considerations. Ensuring that the design and conduct of all research is ethically sound is the responsibility of all involved-including researchers, research institutions, ethics review committees and regulatory bodies.
医疗保健研究一直笼罩在不道德研究的历史阴影之下，在这些研究中，弱势群体遭受了巨大伤害。旨在防止此类可耻事件再次发生的官方研究伦理审批制度，在实际操作中可能会显得官僚主义且缺乏灵活性。尊重自主性、预防伤害、促进受益和公正等核心伦理原则（这些原则构成了研究行为专业准则的基础）必须灵活应用，以考虑到背景、方法、个人和实际等方面的因素。确保所有研究的设计和实施在伦理上站得住脚，是所有相关方的责任，包括研究人员、研究机构、伦理审查委员会和监管机构。
