Striefel S
Utah State University, Utah, USA.
Appl Psychophysiol Biofeedback. 2001 Mar;26(1):39-59; discussion 67-71. doi: 10.1023/a:1009515621157.
La Vaque and Rossiter made a strong, supported argument that it is unethical to use a "no treatment" control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46.
拉瓦克和罗西特提出了一个有力且有依据的论点,即在已有已知有效治疗方法的情况下,在研究中使用“无治疗”对照组是不道德的。他们的论点基于这样一种假设,即《赫尔辛基宣言》是人类研究的道德世界标准。他们的论点看似直截了当,但应用起来并不简单。这些问题非常复杂,包括他们论点中未讨论的问题,并且如本文所指出的,可能会导致不同的结论。世界医学协会制定了《赫尔辛基宣言》作为其官方政策之一。然而,《赫尔辛基宣言》并未被视为世界道德标准,许多专业协会甚至美国联邦政府都未采用这一事实就证明了这一点。也许未提及它是因为其道德条款是理想性的,而非像拉瓦克和罗西特所暗示的那样具有强制性。研究人员和临床医生还应意识到拉瓦克和罗西特论文中未直接讨论的其他伦理问题。《贝尔蒙报告》是至少17个联邦机构对人类研究对象进行伦理保护的基础,该报告未提及《赫尔辛基宣言》。《贝尔蒙报告》提到了几个伦理原则,这些原则构成了知情同意、风险/收益评估、数据保密、受试者选择、机构审查委员会以及在对人类受试者进行研究时所需的其他保护措施的基础。这些核心原则中至少有两条与使用安慰剂对照的讨论直接相关。忠诚的伦理原则在指导涉及人类受试者的研究活动中也很重要。研究人员应该熟悉拉瓦克和罗西特的论点、《贝尔蒙报告》以及为实施该报告条款而制定的联邦政策,例如《联邦法规汇编》第45编第46章。