以死者作为医学研究对象的伦理考量

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[关键词]死者；遗体；伦理审查；知情同意

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）11-1447-06

DOI：10.12026/j.issn.1001-8565.2025.11.10

Abstract： The relevant laws and regulations regarding the utilization of the deceased as medical research subjects are not yet fully developed in China nowadays.Taking the deceased as research subjects as a starting point，this paper discussed the definition of the deceased and the scope of their interest protection from multiple perspectives.It posited that the scope of interest protection for the deceased encompassed two components： spiritual personality interests and material personality interests represented by the remains.The spiritual personality interests of the deceased included identification information such as name，portrait，reputation， honor，privacy，and personal information，as wellas medical and health information. The personal information of the deceased was not directly affected by the individual’s life and death status and remained relatively independent. In terms of ethical review，the research team approached from two perspectives：the remains and the personal information of the deceased.Based on the standard of whether the research subjects involve a human body，research with the remains of the deceased as the medical research subjects was clasified as nonclinical research.According to the standard of whether a human body is clinically operated，research with the personal information of the deceased（including medical and health information）as the medical research subjects was recognized as clinical research without human research operation.This approach provided evidence for the application of existing laws and regulations in ethical review and record management. The ethical review of investigator-initiated clinical research conducted in medical and health institutions，as well as the regulatory conditions forexemption from ethical review，were examined.Theforms，content，and acquisition of informed consent were summarized，and the risk-benefit characteristics of the research activity were evaluated，with a view to providing a basis for the smooth and compliant implementation of research activities involving the deceased asmedical research subjects.

Keywords：thedeceased;remains;ethical review;informed consent

0 问题的提出

随着生命科学和医学研究的不断深人，涉及死者的遗体与个人信息，甚至脑库的研究活动日趋增加，形式也呈多样性发展，但以死者作为医学研究对象的法律法规和伦理审查管理制度尚不健全。（剩余7044字）