Shah Seema, Lie Reidar K
Department of Bioethics, Clinical Center, National Institutes of Health, , Bethesda, Maryland, USA.
J Med Ethics. 2013 Nov;39(11):699-702. doi: 10.1136/medethics-2012-100502. Epub 2013 Jan 15.
In rapidly evolving medical fields where the standard of care or prevention changes frequently, guidelines are increasingly likely to conflict with what participants receive in research. Although guidelines typically set the standard of care, there are some cases in which research can justifiably deviate from guidelines. When guidelines conflict with research, an ethical issue only arises if guidelines are rigorous and should be followed. Next, it is important that the cumulative evidence and the conclusions reached by the guidelines do not eliminate the need for further research. Even when guidelines are rigorous and the study still asks an important question, we argue that there may be good reasons for deviations in three cases: (1) when research poses no greater net risk than the standard of care; (2) when there is a continued need for additional evidence, for example, when subpopulations are not covered by the guidelines; and (3) less frequently, when clinical practice guidelines can be justified by the evidence, but practitioners disagree about the guidelines, and the guidelines are not consistently followed as a result. We suggest that procedural protections may be especially useful in deciding when studies in the third category can proceed.
在医疗领域迅速发展、护理或预防标准频繁变化的情况下，指南越来越有可能与研究参与者所接受的内容相冲突。尽管指南通常设定护理标准，但在某些情况下，研究可以合理地偏离指南。当指南与研究发生冲突时，只有在指南严格且应被遵循的情况下才会出现伦理问题。其次，重要的是指南所依据的累积证据和得出的结论不会消除进一步研究的必要性。即使指南很严格且研究仍提出了一个重要问题，我们认为在以下三种情况下可能有合理的偏离理由：（1）研究带来的净风险不高于护理标准；（2）持续需要额外证据，例如，当指南未涵盖亚人群时；（3）较少见的情况是，临床实践指南有证据支持，但从业者对指南存在分歧，结果导致指南未得到一致遵循。我们建议程序保护在决定第三类研究何时可以进行时可能特别有用。
