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多器官脑死亡供体的精液采集要求:两例报告及巴西现有立法分析

Semen collection requirement from multiple-organs brain-dead donors: report of two cases and analysis of the available Brazilian legislation.

作者信息

Sardinha L A C, Dantas Filho V P, Montone E B B, Athayde M V O, Rodrigues S L L, Panunto M R, Araújo S, Zambelli H J L

机构信息

Organs and Tissue Procurement Program, Hospital de Clinicas-Campinas State University, São Paulo, Brazil.

出版信息

Transplant Proc. 2013 Apr;45(3):1043-5. doi: 10.1016/j.transproceed.2013.02.089.

Abstract

Along with developments in transplantation there have been major breakthroughs in the techniques of assisted reproduction. The areas of common interest include requesting semen collection from organ donors with a diagnosis of brain death. After the recent report of two cases in the Search Service of Organs and Tissues, we analyzed legislation in our country, which still lacks specific guidance in such situations. Organ transplantation progressively established itself as an effective therapeutic option in our country since the 1960s. It represents viable alternative to improve both the quality and length of life as well as to decrease long-term costs of patients with severe end-stage organ failure. These programs have specific rules and laws that are necessary to guide all stages of transplantation: donor identification, authorization and execution as well as recipients selection of implantation techniques. Assisted reproduction also needs legislation specific for human infertility, a public health problem that affects medical, psychological, and legitimate desires of people. The World Health Organization estimates that infertility reaches 20% of the population demanding the development and use of techniques for its treatment. Brazilian legislation includes regulations for transplantation of organs and tissues in law no. 9434 of February 04, 1997; it provides for the removal of organs, tissues, and human body parts for transplantation and other treatments. This law is regulated by Decree no. 2268 of June 30, 1997, establishing the National Transplant System, which standardizes these processes. The postmortem organ and tissue provision must be preceded by a diagnosis of via the Brain Death Protocol (Federal Council of Medicine-Brazil). The sole paragraph of Article 1 makes clear that its provisions do not apply to blood, sperm, or ovules as confirmed by the sole paragraph of Article 1 in the Decree 2.268/97 regulation. Since there is no specific legislation, assisted reproduction in our country is also regulated by The Federal Council of Medicine resolution, which was recently updated (Resolution no. 1957 December 15, 2010 in item VIII), which provides ethical standards for the use of assisted reproduction techniques provides that "It is unlawful ethical assisted reproduction postmortem since there is specific prior authorization of (a) late (a) to the use of cryopreserved biological material, in accordance with current legislation." Standardization is specific to material collected before the diagnosis of brain death, including being subject to expressed and informed consent of both spouses (item 3, item 1, attached single Resolution 1.957/2010 Federal Council of Medicine). We cannot yet find support in these legal provisions even after brain death for postmortem collection of sperm or ovules. Despite the evolution of the assisted reproduction techniques and the recognition of people's rights and wishes to procreate, this matter still creates complicated ethical and legal issues that seem to be far from being solved in our country.

摘要

随着移植技术的发展,辅助生殖技术也取得了重大突破。共同关注的领域包括要求对被诊断为脑死亡的器官捐献者进行精液采集。在器官和组织搜索服务中心最近报告了两例此类病例后,我们分析了我国的立法情况,发现在这种情况下仍缺乏具体指导。自20世纪60年代以来,器官移植在我国逐渐成为一种有效的治疗选择。它是改善严重终末期器官衰竭患者生活质量和延长寿命以及降低长期医疗费用的可行替代方案。这些项目有特定的规则和法律,以指导移植的各个阶段:捐献者的识别、授权和执行,以及受者对植入技术的选择。辅助生殖也需要针对人类不孕症的特定立法,不孕症是一个影响人们医疗、心理和合法生育愿望的公共卫生问题。世界卫生组织估计,不孕症患者占总人口的20%,这推动了治疗技术的开发和应用。巴西立法在1997年2月4日第9434号法律中包括了器官和组织移植的规定;该法律规定了为移植和其他治疗目的而摘取器官、组织和人体部分。该法律由1997年6月30日第2268号法令监管,该法令建立了国家移植系统,对这些程序进行规范。死后器官和组织的提供必须先通过脑死亡协议(巴西医学联邦委员会)进行诊断。第1条的唯一一款明确规定,其条款不适用于血液、精子或卵子,这一点在第2268/97号法令第1条的唯一一款规定中得到了确认。由于没有具体立法,我国的辅助生殖也受医学联邦委员会决议的监管,该决议最近进行了更新(2010年12月15日第1957号决议第八项),该决议为辅助生殖技术的使用提供了道德标准,规定“死后进行辅助生殖不符合伦理道德,因为根据现行法律,在使用冷冻生物材料之前没有提前获得(死者)明确的事先授权”。标准化具体针对脑死亡诊断之前采集的材料,包括需得到配偶双方的明确知情同意(医学联邦委员会第1957/2010号决议附件一第1项第3条)。即使在脑死亡后,我们在这些法律条款中仍找不到支持死后采集精子或卵子的依据。尽管辅助生殖技术不断发展,人们生育的权利和愿望也得到了认可,但这个问题仍然引发了复杂的伦理和法律问题,在我国似乎远未得到解决。

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