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终末期心脏病、高风险研究与同意能力:以阿比奥科人工心脏为例

End-stage heart disease, high-risk research, and competence to consent: the case of the AbioCor artificial heart.

作者信息

Morreim E Haavi

机构信息

Department of Human Values and Ethics, College of Medicine, University of Tennesse, Memphis, TN 38163, USA.

出版信息

Perspect Biol Med. 2006 Winter;49(1):19-34. doi: 10.1353/pbm.2006.0013.

DOI:10.1353/pbm.2006.0013
PMID:16489274
Abstract

Some commentators believe that persons facing imminent death are incapable of making autonomous, informed decisions about whether to enter high-risk, end-of-life research trials. Using the AbioCor artificial heart trial as an example, this essay argues to the contrary. Although some people are incapacitated, many are capable of making such decisions. To forbid dying people to make a decision about whether to enter a clinical trial may insult deeply held personal values at a time when honoring those values may be most important. Moreover, to deny dying persons entry into high-risk clinical trials leaves ethically worse alternatives: using healthier people, requiring surrogates to decide even when the patient is competent, or simply forgoing all research featuring high-risk, potentially life-saving interventions. Once we agree that it is at least sometimes acceptable to permit dying persons to choose high-risk research, a number of practical safeguards can be implemented to ameliorate the challenges that can hinder decision making in this difficult area.

摘要

一些评论家认为,濒临死亡的人无法自主、明智地决定是否参与高风险的临终研究试验。以阿比奥科人工心脏试验为例,本文持相反观点。虽然有些人丧失了行为能力,但许多人有能力做出这样的决定。在尊重这些价值观可能最为重要的时刻,禁止濒死之人决定是否参与临床试验可能会冒犯其根深蒂固的个人价值观。此外,拒绝濒死之人参与高风险临床试验会留下伦理上更糟糕的选择:使用更健康的人,即使患者有行为能力也要求代理人做出决定,或者干脆放弃所有具有高风险、可能挽救生命的干预措施的研究。一旦我们认同允许濒死之人选择高风险研究至少在某些时候是可以接受的,就可以实施一些切实可行的保障措施,以缓解可能阻碍这一困难领域决策的各种挑战。

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