Patient informed consent for a clinical trial of gene-edited pig kidney transplantation: A representative consent form

被引:6
作者
Cooper, David K. C. [1 ,2 ]
机构
[1] Harvard Med Sch, Massachusetts Gen Hosp, Ctr Transplantat Sci, Dept Surg, Boston, MA USA
[2] Massachusetts Gen Hosp, Ctr Transplantat Sci, Dept Surg, Bldg 149, Room 9-016, 19th St, Charlestown, MA 02129 USA
关键词
Clinical trials; Genetic engineering; Informed consent; Kidney; Pig; gene-edited; Xenotransplantation;
D O I
10.1111/xen.12790
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
When clinical trials of gene-edited pig organ transplantation are initiated, the consent form that the patient is requested to sign will be an important document. Consent to receive a pig xenograft will have significant differences when compared with the requirements of most experimental clinical procedures. We here suggest a consent form for pig kidney transplantation that addresses the major points that will be required and hope it will provide a basis for discussion and future modification, if necessary. There is purposely some repetition in the document, but we believe this is necessary to ensure that the patient has a clear understanding of what he/she is consenting to.
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页数:11
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[1]  
Padilla L., 2022, INFORM CONSENT POTEN, V106, P1754, DOI [10.1097/TP0000000000004144, DOI 10.1097/TP0000000000004144]