Research on Human Populations: National and International Ethical Guidelines
Research on Human Populations: National and International Ethical Guidelines
复制标题
人口研究：国家和国际道德准则
DOI：
10.1111/j.1748-720x.1991.tb01808.x
复制
发表时间：
1991
期刊：
影响因子：
--
通讯作者：
R. Levine
中科院分区：
文献类型：
--
作者：
B. Dickens;L. Gostin;R. Levine
世界卫生组织（WHO）、国际医学科学组织理事会（CIOMS）和美国公共卫生署（PHS）都在积极参与人体受试者研究指南的改革和整合。在回顾这些著名的国家和国际机构目前的活动之前，我们想考虑一下研究伦理学领域重新引起兴趣的一些原因。几十年来，临床和公共卫生研究一直包括对整个人群的大规模研究，包括药物和疫苗的实地试验。一些更重要的研究涉及数百或数千人，通常在多个研究中心。到目前为止，道德准则强调的是个人的负担，而不是受影响社区的负担。虽然这些道德准则充分保护了个人知情同意和保密的权利，但它们并没有充分解决可能对社区作为一个整体和可行实体的习俗和完整性造成的伤害，也没有解决社区获得可能改善医疗保健的研究结果的权利。1991年以前，反映对这些问题敏感性的唯一文件也许是1982年国际海洋学理事会提出的准则。艾滋病迫使我们在流行病学研究中认真对待保护社区权利的必要性。将海地人列为“危险群体”所引起的问题和撒哈拉以南国家的关切影响了最近系统考虑影响社区的研究伦理的趋势。研究人员也越来越多地参与国际合作研究。这种类型的研究涉及来自一个社区或国家的赞助商和研究人员在另一个社区或国家进行研究，这些社区或国家可能具有不同的文化。对艾滋病、生殖健康和环境健康的研究说明了但绝不是界定了国际合作研究的范围。目前的守则没有为有效和合乎道德的合作研究所需的规划、合作和文化敏感性提供充分的指导。社会对研究的看法也发生了变化。多年来，人们对研究的看法受到纽伦堡暴行和塔斯基吉对研究对象不合理忽视的报道的影响。因此，当前的伦理准则，如《赫尔辛基宣言》的主要目标是确保知情同意和研究的利益与负担之间的有利平衡，并保护弱势群体。这些目标在今天同世界医学协会1964年首次通过《赫尔辛基宣言》时一样重要，该宣言现在已是第四版。现代研究，然而，被视为与其说是一个负担的主题作为一个机会的主题。许多患有严重疾病和疾病的人，以及没有现成的治疗方法的人，积极寻求参与临床试验。患有艾滋病或无法治愈的癌症的人认为，获得临床研究是他们的道德权利。在美国，特别是在艾滋病药物方面，扩大获得和社区试验的运动清楚地表明，政府和疾病患者发生了多大的变化。的运动
The World Health Organization (WHO), the Council for International Organizations of Medical Sciences (CIOMS), and the United States Public Health Service (PHS) are all actively engaged in the reform and consolidation of guidelines for human subject research. Before the current activities of these prestigious national and international bodies are reviewed, we would like to consider some of the reasons for the resurgence of interest in the field of research ethics. Clinical and public health research has for decades included larger scale studies on whole populations-studies that include field trials of drugs and vaccines. Some of the more important studies involve hundreds or thousands of persons, often in multiple research centers. Up to now, ethical guidelines have emphasized the burdens on individuals rather than the burdens on the communities affected. While these ethical guidelines adequately protect the right of the individual to informed consent and confidentiality, they do not adequately address such harms as may be done to the customs and integrity of communities as whoIe and viable entities, nor community rights such as to receive results of studies that may improve health care. Perhaps the only document to reflect any sensitivity to these issues before 1991 was the 1982 CIOMS proposed guidelines. AIDS has forced us to come to grips with the need for protection of community rights in epidemiological research. The problems raised by labeling Haitians as a “risk group” and the concerns of sub-Saharan nations have influenced the recent trend towards systematic consideration of the ethics of research that affects communities. Researchers are also increasingly engaged in international collaborative research. This type of research involves sponsors and investigators from one community or country conducting research in another community or country which may have a different culture. Studies in AIDS, reproductive health and environmental health illustrate but by no means define the scope of international collaborative research. Current codes do not provide adequate guidance for the planning, cooperation and cultural sensitivity necessary for effective and ethical collaborative research. Society has also evolved in its perceptions of research. For many years, perceptions of research were influenced by reports of the atrocities of Nuremberg and the unconscionable neglect of subjects at Tuskegee. As a result, the principal goals of current ethical guidelines, such as the Helsinki Declaration, are to ensure informed consent and a favorable balance between the benefits and burdens of research, and to protect vulnerable persons. These goals are as important today as they were when the World Medical Association first adopted the Helsinki Declaration, now in its fourth version, in 1964. Modern research, however, is viewed not so much as a burden on the subject as an opportunity for the subject. Many people with serious illness and disease, and who have no estabiished treatment available, actively seek to participate in clinical trials. Persons with AIDS or incurable cancer see it as their moral right to have access to clinical research. The movement in the United States toward expanded access and community trials, particularly in regard to AIDS drugs, show clearly how much government and persons with disease have changed. The movement for