医疗护理标准之争：《赫尔辛基宣言》与国际共识意见
The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.
作者信息
Lie R K, Emanuel E, Grady C, Wendler D
机构信息
Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway.
出版信息
J Med Ethics. 2004 Apr;30(2):190-3. doi: 10.1136/jme.2003.006031.
Abstract
The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.
摘要
世界医学协会修订的《赫尔辛基宣言》赞同这样一种观点，即每个国家的所有试验参与者都有权获得全球最佳的医疗护理标准。在本文中，作者表明，每一个审查过这个问题的国家和国际委员会都拒绝了这一要求。他们认为，目前的共识观点是，在某些情况下，在伦理上允许为研究参与者提供低于全球最佳护理水平的护理。最后，作者表明，对于在哪些广泛条件下这是可以接受的，也存在共识。
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本文引用的文献
1
International research ethics.
Bioethics. 2000 Apr;14(2):158-72. doi: 10.1111/1467-8519.00187.
2
Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases.
Ann Intern Med. 2000 Sep 19;133(6):464-70. doi: 10.7326/0003-4819-133-6-200009190-00015.
3
Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues.
Ann Intern Med. 2000 Sep 19;133(6):455-63. doi: 10.7326/0003-4819-133-6-200009190-00014.
4
Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
J Med Ethics. 2000 Feb;26(1):37-43. doi: 10.1136/jme.26.1.37.
5
Proposed revisions to the Declaration of Helsinki--will they weaken the ethical principles underlying human research?
N Engl J Med. 1999 Aug 12;341(7):527-31. doi: 10.1056/NEJM199908123410712.
6
Placebo controls in HIV perinatal transmission trials: a South African's viewpoint.
Am J Public Health. 1998 Apr;88(4):564-6. doi: 10.2105/ajph.88.4.564.
7
Human rights and maternal-fetal HIV transmission prevention trials in Africa.
Am J Public Health. 1998 Apr;88(4):560-3. doi: 10.2105/ajph.88.4.560.
8
Ethical complexities of conducting research in developing countries.
N Engl J Med. 1997 Oct 2;337(14):1003-5. doi: 10.1056/NEJM199710023371411.
9
Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.
N Engl J Med. 1997 Sep 18;337(12):853-6. doi: 10.1056/NEJM199709183371212.
10
The ethics of clinical research in the Third World.
N Engl J Med. 1997 Sep 18;337(12):847-9. doi: 10.1056/NEJM199709183371209.
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