Research study coordinator in the Department of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine.
Dollard Professor of Psychiatry, Medicine, & Law, the director of the Division of Law, Ethics, and Psychiatry, and the director of the Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics at Columbia University College of Physicians & Surgeons.
Ethics Hum Res. 2021 Mar;43(2):28-34. doi: 10.1002/eahr.500084.
A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.
一位孕妇参加了一项双盲随机对照试验(RCT),参与者被随机分配到安慰剂组或正在测试的药物组,以预防高血压并发症。完成试验后,研究参与者坚持要求被告知她接受了哪种药物,为未来的怀孕做准备。这个案例强调了 RCT 程序中一个很少受到关注的要素——是否在参与者参与结束时解除对研究的盲法。鉴于解除盲法不是非严重不良事件的标准做法,调查人员采取哪些行动是合理的?为了综合这个案例的信息,我们使用了国家卫生保健伦理中心创建的 CASES 模型来分析伦理案例。指导研究的伦理原则强调与参与者的沟通以及在科学目标的限制内减少伤害的重要性。参与者可能希望知道他们未来的医疗保健决策中使用了哪种药物。我们回顾了解除盲法的利弊信息。
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