Regidor Enrique
Department of Preventive Medicine, Public Health and History of Science, Faculty of Medicine, Universidad Complutense de Madrid, Ciudad Universitaria, Madrid 28040, Spain.
Soc Sci Med. 2004 Nov;59(9):1975-84. doi: 10.1016/j.socscimed.2004.02.032.
This paper discusses the moral justification for using personal data without informed consent, from both medical records and biological materials, in research where subjects are not physically present in the study and will never have any contact with the study investigators. Although the idea of waiving the requirement for informed consent in certain investigations has been mentioned in several ethical guidelines formulated by epidemiologists and physicians since the late 1980s, these guidelines are now of limited use due to legal restrictions on the use of personal data in most western countries. Several misconceptions that form the basis for legal restriction of health research are discussed: lack of knowledge of the need to link personal information from health services with personal information produced outside the health system in many biomedical investigations; the assumption of a deterministic model of disease causation in which the prediction of disease occurrence is based on a genetic association despite the fact that most genotypes for common diseases are incompletely penetrant; the lack of a logical rationale for the recommendation in the Declaration of Helsinki that only research that offers some benefit to study subjects is justified; the great lack of knowledge about research methodology revealed in some alternatives proposed to avoid using personal data; and the lack of a debate about the ethical double standard of institutions and investigators in countries that prohibit the use of personal data but finance and carry out studies in other countries where it is permitted.
本文探讨了在研究中未经知情同意使用个人数据（包括医疗记录和生物材料）的道德合理性，这些研究中的受试者并不实际参与研究，且永远不会与研究调查人员有任何接触。尽管自20世纪80年代末以来，流行病学家和医生制定的若干伦理准则中提到了在某些调查中免除知情同意要求的想法，但由于大多数西方国家对个人数据使用的法律限制，这些准则现在的用途有限。本文讨论了构成健康研究法律限制基础的几个误解：在许多生物医学调查中，缺乏将健康服务中的个人信息与健康系统外产生的个人信息相联系的必要性的认识；尽管常见疾病的大多数基因型不完全显性，但仍假设疾病因果关系的决定论模型，即疾病发生的预测基于基因关联；《赫尔辛基宣言》中建议只有对研究对象有一定益处的研究才合理，但缺乏逻辑依据；为避免使用个人数据而提出的一些替代方案中，对研究方法的了解严重不足；以及在禁止使用个人数据但在允许使用个人数据的其他国家资助并开展研究的国家，机构和研究人员的伦理双重标准缺乏讨论。
