Elger Bernice S, Hofner Marie-Claude, Mangin Patrice
University Center of Legal Medicine of Geneva and Lausanne, University of Geneva, Switzerland.
Pathobiology. 2009;76(1):1-10. doi: 10.1159/000178150. Epub 2009 Feb 2.
Recommendations and laws do not always contain specific and clear provisions on the use of cadaveric material in research, and even more rarely do they address explicitly the ethical issues related to research on material obtained during forensic autopsy. In this article we analyse existing legal frameworks in Europe by comparing the legal provisions in 2 European Countries which are member states of the Council of Europe, the UK and Switzerland. They were chosen because they have distinct legal frameworks that make comparisons interesting. In addition, the detailed laws of the UK and a specific law project and national ethical recommendations in Switzerland permit us to define more clearly the legal range of options for researchers using cadaveric material obtained during forensic investigations. The Human Tissue Act 2004 in England, Wales and Northern Ireland, its Scottish equivalent with the same title (2006) and the national ethical guidelines in Switzerland all require consent from the deceased person, an appropriate relative or a person with power of attorney for healthcare decisions before cadaveric biological material can be obtained and used for research. However, if the purpose of the autopsy is purely forensic, no such authorization will be sought to carry out the autopsy and related analyses, which might include genetic testing. In order to be allowed to carry out future research projects, families need to be approached for informed consent, unless the deceased person had left written directives including permission to use his or her tissues for research.
建议和法律并不总是包含关于在研究中使用尸体材料的具体明确规定,更罕见的是,它们明确涉及与法医尸检期间获得的材料研究相关的伦理问题。在本文中,我们通过比较欧洲两个欧洲委员会成员国(英国和瑞士)的法律规定,分析了欧洲现有的法律框架。选择它们是因为它们有不同的法律框架,这使得比较很有意义。此外,英国的详细法律以及瑞士的一项具体法律项目和国家伦理建议,使我们能够更清楚地界定研究人员使用法医调查期间获得的尸体材料的合法选择范围。英格兰、威尔士和北爱尔兰的《2004年人体组织法》、其苏格兰同名等效法律(2006年)以及瑞士的国家伦理准则都要求在获取和使用尸体生物材料进行研究之前,获得死者、适当的亲属或具有医疗保健决策权的授权人的同意。然而,如果尸检目的纯粹是法医性质的,则在进行尸检及相关分析(可能包括基因检测)时不会寻求此类授权。为了被允许开展未来的研究项目,除非死者留下书面指示,包括允许使用其组织进行研究,否则需要与家属联系以获得知情同意。