研究成果的受试者获益之伦理原则分析

Analysis of the Ethical Principle of Subjects' Benefit after the Clinical Research

《涉及人的生物医学研究国际伦理准则》(简称CIOMS)1993年版最早提出了关于临床研究结束后受试者继续获益的伦理原则。《赫尔辛基宣言》2000年版也首次做出了相关规定,但是引起了很大争议,争议集中在两个方面:(1)有没有义务确保研究结束后的受试者继续获益?(2)谁来承担此义务?围绕这些争议,CIOMS和《赫尔辛基宣言》的相关条款经历了多次修订,在一定程度上平衡了各方的利益,但是仍然给具体操作留下了很多问题,同时给伦理审查提出了很大的挑战。

The 1993 edition of International Guidelines for Biomedical Research Involving Human Subjects(CIOMS)first proposed the ethical principle of continuing to benefit the subjects after the clinical research.The 2000 edition of Declaration of Helsinki also made the relevant provisions for the first time,which had caused great controversy,focusing on two aspects:(1)is there an obligation to ensure that the subjects continue to benefit after the research?(2)Who should take this obligation?Around these controversies,the relevant provisions of CIOMS and Declaration of Helsinki had undergone many revisions,balancing the interests of all parties to a certain extent,while it still left many problems for the practice,and also posed great challenges for ethical review.