Wenner Danielle M
Bioethics. 2017 Feb;31(2):97-104. doi: 10.1111/bioe.12316.
Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant social value of the kind necessary to fulfill the social value requirement. The article goes on to illustrate how this framework can provide a clearer account of the responsiveness requirement, an ethical dictum that is oft-repeated but whose content and value as a guideline in international research remains contested. Although I introduce this conception of social value in the context of the responsiveness requirement, the account offered can, and is intended to, stand alone as a tool for the assessment of the social value of research. As such it can be usefully applied to discussions about the value of comparative effectiveness trials, the assessment of the continued proliferation of me-too drugs and the research done to develop them, the demand for public access to study-generated data, and persistent deficits in the publication of negative results.
伦理学家早就认识到，伦理研究有两个必要特征：科学有效性和社会价值。然而，尽管围绕这一要求的有效性部分有大量文献，但直到最近，对于剖析社会价值部分可能需要什么却很少有人关注。本文介绍了一个评估研究社会价值的框架，特别是用于确定某个特定研究项目是否可能具有满足社会价值要求所需的那种重大社会价值。本文接着说明这个框架如何能够更清晰地阐述响应性要求，这是一条经常被重复的伦理准则，但其作为国际研究指南的内容和价值仍存在争议。虽然我是在响应性要求的背景下引入这种社会价值概念的，但所提供的阐述能够而且旨在独立作为评估研究社会价值的工具。因此，它可有效地应用于关于比较有效性试验价值的讨论、对仿制药持续泛滥及其研发研究的评估、公众获取研究产生数据的需求，以及负面结果发表方面的持续不足等问题。
