Keating Bernard
Faculté de théologie et de sciences religieuses, Centre de recherche Université Laval Robert-Giffard, Université Laval, 2601, avenue de la Canardière, Beauport, Québec, G1J 2G3, Canada.
Med Sci (Paris). 2004 Jan;20(1):118-25. doi: 10.1051/medsci/2004201118.
The question of the use of the placebo is one of the most controversial in the field of the ethics of research today. The use of the placebo remains the standard practice of biomedical research in spite of the fact that various revisions of the Helsinki Declaration have sought to limit its use. In Canada, the Tri-council policy statement: Ethical conduct for research involving humans adopted a very restrictive position with respect to the use of placebos, precisely defining the situations in which its use would meet the demands of ethical research. The positions taken by the various ethical decision-making bodies are, however, hardly shared by regulatory bodies such as the Food and drug administration (FDA), the Council for international organization of medical sciences (CIOMS) or the European agency for the evaluation of medicinal products (EMEA). This divergence of opinions reveals two quite different conceptions of what constitutes the ethical. In the case of decision-making bodies in the ethical field, it is clearly medicine's Hippocratic Oath which explains their reluctance to use placebos. The first responsibility of the doctor is to "do no harm" to his or her patient. This duty is inherent to the medical profession and as such is not grounded in the view of medicine as a contract for care. In the case of regulatory bodies, it is the vision of "medicine as contract" which is in view; and it is this notion that justifies the use of placebos once free and informed consent has been obtained. It is also worth noting that these regulatory bodies make frequent use of arguments based on utilitarian ends. In an unprecedented move, the World medical association published in October 2001 a clarification note about the use of placebos. An analysis of this text raises the question about its real meaning: clarification or concession?
安慰剂的使用问题是当今研究伦理领域最具争议性的问题之一。尽管《赫尔辛基宣言》的各种修订版都试图限制安慰剂的使用，但它仍是生物医学研究的标准做法。在加拿大，三理事会政策声明《涉及人类的研究的伦理行为》对安慰剂的使用采取了非常严格的立场，精确界定了其使用符合伦理研究要求的情形。然而，食品药品监督管理局（FDA）、国际医学科学组织理事会（CIOMS）或欧洲药品评估局（EMEA）等监管机构几乎不认同各伦理决策机构的立场。这种意见分歧揭示了对于何为符合伦理存在两种截然不同的观念。就伦理领域的决策机构而言，显然是医学的希波克拉底誓言解释了它们不愿使用安慰剂的原因。医生的首要责任是不对其患者“造成伤害”。这项职责是医学专业所固有的，因此并非基于将医学视为护理契约的观点。就监管机构而言，其秉持的是“医学即契约”的观点；正是这种观念使得在获得自由且知情的同意后使用安慰剂具有正当性。还值得注意的是，这些监管机构经常使用基于功利主义目的的论据。世界医学协会在2001年10月发布了一份关于安慰剂使用的澄清说明，这是一次史无前例的举动。对该文本的分析引发了关于其真正含义的问题：是澄清还是让步？
