亲属活体肾移植的伦理学审查:单中心经验总结

目的总结单中心亲属活体肾移植的伦理学审查经验。方法成立北京大学第三医院人体器官移植临床应用与管理伦理委员会(伦理委员会),对130例次在该院拟行亲属活体肾移植的供、受者进行伦理学审查。以国务院《人体器官移植条例》为依据,先对供、受者进行科内初审,然后召开伦理委员会会议进行审查,内容包括移植供、者双方关系是否为亲属,双方术前检查结果是否符合移植要求,供者是否具有完全民事能力,双方是否了解手术风险,供者是否完全自愿捐献,其亲属是否同意,双方是否签署书面知情同意书等。根据审查结果确定能否进行手术。结果 120例次得到批准并顺利完成了肾移植手术,供受双方恢复满意,无发生纠纷。10例次被否决,其中不能确定亲属关系5例次,双方术前检查结果不符合移植要求2例次,供者无完全民事能力1例次,供者配偶不同意移植1例次,非本人真实意愿捐肾1例次。结论成立伦理委员会,严格按照《人体器官移植条例》的要求对拟行亲属活体肾移植的供、受者双方进行伦理学审查可保证器官移植的规范性和医疗安全性。

Ethical inspection in living-related doonor renal transplantation: a single-center experience

Objective To sum up a single-center experience of ethical inspections in living-related donor renal transplantation.Methods The Ethics Committees of Clinical Application and Management on Human Organ Transplantation(ethics committees) was established in the Third Hospital of Peking University.One hundred and thirty cases were inspected by ethics committees before living-related donor renal transplantation.According to Regulations on Human Organ Transplantation,donors and recipients were inspected by urology department first and then by the ethics committee.The inspection included validity of kinship between donor and recipient,qualification of requirements of preoperative examination results,full civil capacity of donor,understanding of operation risks by both sides,free will of donation of the donor,agreements of the donor’s relatives and informed consents by both sides.The results of inspection determined whether to perform the operation or not.Results One hundred and twenty cases were approved and surgeries were completed successfully with good outcome.No disputes occurred.Ten cases were rejected due to a variety of reasons,including 5 cases with suspicious kinship between donors and recipients,2 cases with unqualified preoperative examination results,1 case with donor’s lack of full civil capacity,1 case with disagreement of donor’s spouse and 1 case with coercive donation.Conclusions The establishment of ethics committees on organ transplantation and strict inspections on donors and recipients according to Regulations on Human Organ Transplantation have vital importance to ensure the normalization and medical security of organ transplantation.