隐藏的替代方案:在研究之外获得试验性治疗
1Department of History and Philosophy of Medicine, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, Kansas 66160-7311, USA. jmenikof@kumc.edu
Lancet (London, England)
|January 9, 2003
概括
许多临床试验没有告知参与者,他们可以在研究之外获得新的治疗方法. 这种做法,即使是在大型乳腺癌预防试验中,也可能损害自愿知情同意和伦理研究标准.
科学领域:
- 临床研究伦理学
- 医学研究政策 医学研究政策
背景情况:
- 临床试验经常将患者随机选择为标准与新疗法.
- 在临床试验之外,研究中的新疗法往往是可用的.
研究的目的:
- 检查不通知研究参与者直接获得研究治疗的伦理影响.
- 评估这种做法对知情同意自愿性的影响.
主要方法:
- 分析临床研究参与者招聘当前的做法.
- 审查美国政府政策及其对研究设计和同意程序的影响.
- 对大规模政府资助的试验进行案例研究,如他莫西芬和拉洛西芬乳腺癌预防研究.
主要成果:
- 美国政策鼓励的常见做法是,不向潜在的研究参与者提供有关直接治疗的信息.
- 这种不披露甚至发生在大型,联邦资助的研究中,例如乳腺癌预防试验.
- 这种做法可能会膨胀研究参与,但破坏了知情同意的自愿性.
结论:
- 临床研究当前的政策和实践可能会导致伦理上有疑问的研究设计.
- 当参与者不知道可以获得替代治疗时,知情同意的自愿性就会受到损害.
- 对有关参与者信息披露的道德准则和政府政策进行重新评估是有必要的.
关键词:
生物医学和行为研究研究.
相关概念视频
02:57Targeted Cancer Therapies
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
There are several types of targeted therapies against specific...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
01:26Pharmaceutical Poisoning: Treatment Strategies
Treatment strategies for poisoning are a critical aspect of emergency medicine, focusing on preventing the absorption of toxins and enhancing their elimination. When a poisoning incident occurs, the first response is to halt exposure and decontaminate the patient, particularly through gastrointestinal (GI) methods if the poison was ingested.Gastrointestinal Decontamination Techniques:Activated charcoal is the cornerstone of GI decontamination. It works through adsorption, binding the toxin to...