Orr R D
Loma Linda University Medical Center, CA 92354, USA.
Psychiatr Serv. 1996 Nov;47(11):1262-4. doi: 10.1176/ps.47.11.1262.
Federal regulations governing pharmacologic research require scientific proof of efficacy. Although these regulations are often interpreted to mean that a placebo-controlled trial is necessary, it is difficult to justify use of placebo controls when effective standard therapy exists. Justification is especially problematic in psychopharmacologic research because of the added concern that subjects with compromised decision-making capacity cannot give valid consent. To promote discussion and consensus, this article presents guidelines for the ethically justifiable use of placebo controls in research with psychopharmacologic agents. The guidelines, developed by a university's institutional review board, are designed to help investigators design studies and to protect vulnerable subjects.
管理药理学研究的联邦法规要求有疗效的科学证据。尽管这些法规常常被解释为意味着有必要进行安慰剂对照试验，但当存在有效的标准疗法时，很难证明使用安慰剂对照是合理的。在精神药理学研究中，由于额外担心决策能力受损的受试者无法给出有效的同意，所以证明其合理性尤其成问题。为了促进讨论和达成共识，本文提出了在精神药理学药物研究中伦理上合理使用安慰剂对照的指导原则。这些由一所大学的机构审查委员会制定的指导原则旨在帮助研究人员设计研究并保护易受伤害的受试者。
