Woodward B
Department of Philosophy, Brandeis University, Waltham, Mass 02454, USA.
JAMA. 1999 Nov 24;282(20):1947-52. doi: 10.1001/jama.282.20.1947.
United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.
美国关于联邦政府资助的人体研究的法规部分源自两项国际准则，即《纽伦堡法典》和《赫尔辛基宣言》。《赫尔辛基宣言》指出：“对受试者利益的关注必须始终高于对科学和社会的利益。”最小风险概念和知情同意原则是美国联邦法规用以在研究环境中保护个人权利和福利的关键手段。医学研究的当前趋势——包括资金增加、计算机能力不断增强、可用于研究的新临床工具的开发以及通过研究本身开发的新研究工具——正在对人体受试者产生更大需求，以便更轻松地招募和征募这些受试者，并能不受阻碍地获取患者病历和人体生物材料。在国内和国际上，存在着将受试者利益置于科学和社会利益之下的新压力。即将对美国人体受试者保护体系进行全面审查的国家生物伦理咨询委员会面临着一项艰巨任务。
