Siegel Andrew, Anderson Martha W, Schmidt Tracy C, Youngner Stuart J
Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Cell Tissue Bank. 2009 Aug;10(3):235-40. doi: 10.1007/s10561-008-9115-y. Epub 2008 Nov 19.
Nearly 10 years ago, the tissue industry's informed consent practices with donor families in the United States were criticized. In response, the industry, along with the Inspector General of the Department of Health and Human Services, suggested elements to be included in the informed consent process. This study examines which of these elements were present in the informed consent documents of 45 (78%) of the nation's 58 Organ Procurement Organizations (OPOs). Some elements, such as involvement of for-profit companies, were present in almost all. Others, such as labeling tissue as a gift from donor families, never were. The authors conclude that the time is ripe for reexamination of the informed consent process with an eye to meaningful consent that promotes the benefits of tissue transplantation and at the same time protects the rights and interests of donor families; can be realistically implemented; and, maintains the trust of the American public.
近10年前，美国组织行业针对捐赠者家属的知情同意做法受到了批评。作为回应，该行业与卫生与公众服务部监察长一道，提出了知情同意过程中应包含的要素。本研究调查了全国58个器官采购组织（OPO）中的45个（78%）的知情同意文件中存在哪些此类要素。一些要素，如营利性公司的参与，几乎在所有文件中都有。而其他要素，如将组织标记为捐赠者家属的礼物，则从未出现过。作者得出结论，重新审视知情同意过程的时机已经成熟，目的是达成有意义的同意，既能促进组织移植的益处，又能同时保护捐赠者家属的权益；能够切实可行地实施；并能维持美国公众的信任。
