Ethics of the use of placebos in clinical research: a proposal for decision-making algorithms

Abstract The use of placebos in clinical research has been a matter of considerable debate in recent years, notably when the World Medical Association published, in 2002, a note of clarification for paragraph 29 of the Helsinki Declaration. Brazil is known for its strong opposition to the flexible use of placebos. Both the Federal Council of Medicine and the National Health Council have published resolutions regulating the use of placebos in Brazil, preventing their use if there is a more effective therapeutic method already in place. The present study reinforces that position and aims to describe the various uses of placebos in clinical research, as well as examining the complex decisions relating to the ethics of their use. Additionally, the authors propose a reflection on the use of placebos through decision-making algorithms based on Brazilian ethical standards.

摘要
近年来，安慰剂在临床研究中的应用始终是颇具争议的议题，尤为关键的是，世界医学协会（World Medical Association）于2002年针对《赫尔辛基宣言》第29条发布了澄清说明。巴西素来坚决反对灵活使用安慰剂，该国联邦医学委员会（Federal Council of Medicine）与国家卫生委员会（National Health Council）均已发布规制安慰剂使用的决议，明确规定若已有更为有效的治疗手段，则不得使用安慰剂。本研究秉持该立场，旨在阐明安慰剂在临床研究中的各类应用场景，并探析与其使用相关的复杂伦理决策问题。此外，作者倡议基于巴西伦理规范，借助决策算法对安慰剂的使用开展伦理反思。