Schellings R, Sturmans F, Kessels A G
Capaciteitsgroep Epidemiologie, Universiteit Maastricht.
Ned Tijdschr Geneeskd. 1999 May 15;143(20):1033-7.
Since World War II, all sorts of protective measures have been taken for people who receive medical care or who are involved in scientific research. More and more, informed consent has become the standard. In the field of experimental therapeutical research, informed consent is still a controversial subject; the individual person's interests versus general interests. But informed consent appears to have become such an absolute prerequisite for all types of observational research that the future of epidemiological research based on existing data is threatened. According to both the Declaration of Helsinki and the Dutch Law for Protection of Persons, it is possible to omit asking individual informed consent under certain circumstances. Permission for research could then be given by a supervisory board or a medical-ethical commission. After all, informed consent was never meant to be a goal of its own, but a means for self-protection and securing the right to autonomy. In situations where this right is curbed for other reasons, it appears that insisting on informed consent misses its target completely.
自第二次世界大战以来,针对接受医疗护理或参与科学研究的人员采取了各种保护措施。知情同意越来越成为标准做法。在实验性治疗研究领域,知情同意仍然是一个有争议的话题;涉及个人利益与普遍利益的权衡。但知情同意似乎已成为各类观察性研究的绝对前提条件,以至于基于现有数据的流行病学研究的未来受到威胁。根据《赫尔辛基宣言》和荷兰的《保护个人法》,在某些情况下可以省略征求个人知情同意的程序。届时,研究许可可由监督委员会或医学伦理委员会给予。毕竟,知情同意从来都不是目的本身,而是自我保护和保障自主权的一种手段。在因其他原因该权利受到限制的情况下,坚持要求知情同意似乎完全偏离了目标。