HISTORICAL BACKGROUND OF CLINICAL-TRIALS INVOLVING WOMEN AND MINORITIES
HISTORICAL BACKGROUND OF CLINICAL-TRIALS INVOLVING WOMEN AND MINORITIES
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DOI：
10.1097/00001888-199409000-00002
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发表时间：
1994-09-01
影响因子：
7.4
通讯作者：
MCCARTHY, CR
中科院分区：
文献类型：
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作者：
MCCARTHY, CR
作者为将女性和少数群体成员纳入临床研究相关的困难伦理和临床问题提供了历史背景。他引用了 20 世纪 40 年代末的《纽伦堡法典》作为出发点，该法典宣布了作为研究对象的人类的基本尊严，这一原则很快得到了全世界的认可。从二战后到 20 世纪 70 年代，美国对研究对象的普遍态度（并不总是如此）是，他们应该受到保护，免受剥削。这种态度反映在 1966 年制定的第一个关于研究主题的广泛联邦政策中。在那些年里，公众普遍认为研究是危险的，对个人参与者来说没有什么价值；值得注意的是，当时有如此多的男性和女性同意参加临床研究。此外，在 20 世纪 70 年代，由于作者所解释的原因，发生了各种事件——堕胎辩论、臭名昭著的塔斯基吉梅毒研究的披露、尼克松的“癌症战争”、1974 年和 1975 年的新联邦法规（后者为研究中的孕妇提供了额外的保护）、FDA 1977 年政策的广泛解释，该政策将怀孕或可能怀孕的妇女排除在临床试验之外，以及黑人和黑人的倾向。来自其他少数群体的人回避参与研究——往往会阻碍参与。临床研究中的女性和少数群体成员。但在 20 世纪 80 年代，人们的态度发生了巨大变化：参与研究被认为是获得廉价医疗保健的一种有吸引力的方式；对参与的恐惧消退了；妇女权利运动意识到许多药物从未在有生育能力的妇女身上进行过测试，因此敦促调查人员纳入更多妇女；艾滋病的出现鼓励了人们作为研究对象的参与，并助长了这样一种观念：妇女被排除在非常理想的研究之外。作者认为，许多早期的风险是存在的。尽管科学质量和为受试者提供的保护有所提高，但研究负担仍然是合理的，并敦促研究人员和赞助组织在处理是否包括妇女和个人的问题时，让仁慈、正义和自主原则指导他们。来自研究中的少数群体。夸大研究负担或预期收益都是对研究对象的不公正。在寻求适当的平衡时，历史记录提供了宝贵的教训。
The author provides a historical context for the difficult ethical and clinical issues associated with the inclusion of women and members of minority groups in clinical research. He cites as a point of departure the Nuremberg Code of the late 1940s, which declared the fundamental dignity of human beings involved as research subjects, a principle that was quickly endorsed worldwide. From the period following World War II through the 1970s, the prevailing attitude-not always practiced-toward research subjects in the United States was that they should be protected from exploitation. That attitude was reflected in the first broad federal policy on research subjects, created in 1966. During those years, research was widely regarded by the public as dangerous and of little value to individual participants; it is remarkable that so many men and women consented to participate in clinical studies at that time. Furthermore, during the 1970s, for reasons explained by the author, various events-the abortion debate, disclosures from the infamous Tuskegee syphilis study, Nixon's ''war on cancer,'' new federal regulations in 1974 and 1975 (the latter providing additional protection for pregnant women in research), the broad interpretation of the FDA's 1977 policy excluding pregnant or potentially pregnant women from clinical trials, and the tendency of blacks and persons from other minority groups to shun participation in research-tended to deter participation. of women and members of minority groups in clinical research. But during the 1980s attitudes changed dramatically: participation in research was regarded as an attractive way to receive inexpensive health care; the fear of participation receded; the women's rights movement, aware that many drugs had never been tested in Women of childbearing potential, urged investigators to include more women; and the emergence of AIDS encouraged, people's participation as research subjects and helped foster the notion that women had been excluded from highly desirable research. The author-maintains that many of the early fears of the risks. and burdens of research are still justified despite the improved quality of both science and the protections provided to subjects, and urges investigators and sponsoring organizations alike to let the principles of beneficence, justice, and autonomy guide them as they deal with the questions of whether to include women and persons. from minority groups in research. To overstate either the burdens of research or the expected benefits is to do research subjects an injustice. In seeking the proper balance, the historical record provides valuable lessons.