Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

中文翻译：

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研究中歪曲“常规护理”：伦理和科学错误。


比较有效性研究（此处称为“常规护理”试验）旨在比较针对相同医疗状况的当前医疗实践。此类研究被认为是安全的并且风险很小。然而，如果试验设计包含“不寻常”的护理，则该推定可能有缺陷，从而导致受试者存在潜在风险和不准确的知情同意。这里描述的三个案例研究并不依赖临床证据来确定同期实践。结果，研究人员得出了不准确的结论，向研究参与者提供了错误的信息，受试者的安全受到损害。在批准常规护理方案之前，IRB 和科学审查委员会应评估记录常规护理实践的信息的质量和完整性。政府监督机构对当前临床实践的循证记录的指导可以防止未来常规护理试验中发生类似情况。为了确保试验符合政府法规（要求最大限度地减少受试者的研究风险）和准确的知情同意文件，准确的信息是必要的。