Bioethics Program, University of California Davis, Sacramento, California, United States of America.
Julius Centrum, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.
PLoS Biol. 2018 Jun 6;16(6):e2006343. doi: 10.1371/journal.pbio.2006343. eCollection 2018 Jun.
Millions of people worldwide currently suffer from serious neurological diseases and injuries for which there are few, and often no, effective treatments. The paucity of effective interventions is, no doubt, due in large part to the complexity of the disorders, as well as our currently limited understanding of their pathophysiology. The bleak picture for patients, however, is also attributable to avoidable impediments stemming from quality concerns in preclinical research that often escape detection by research regulation efforts. In our essay, we connect the dots between these concerns about the quality of preclinical research and their potential ethical impact on the patients who volunteer for early trials of interventions informed by it. We do so in hopes that a greater appreciation among preclinical researchers of these serious ethical consequences can lead to a greater commitment within the research community to adopt widely available tools and measures that can help to improve the quality of research.
目前，全球数百万人患有严重的神经疾病和损伤，但针对这些疾病和损伤，我们几乎没有（甚至没有）有效的治疗方法。干预措施效果不佳的原因无疑主要是因为这些疾病和损伤非常复杂，而且我们目前对其病理生理学的了解也很有限。然而，患者的前景黯淡，也归因于临床前研究中质量问题造成的不可避免的障碍，而这些问题往往逃脱了研究监管努力的检测。在我们的文章中，我们将临床前研究质量方面的这些担忧及其对参与基于这些研究的干预措施早期试验的志愿者患者可能产生的潜在伦理影响联系起来。我们这样做是希望临床前研究人员能够更多地意识到这些严重的伦理后果，从而促使研究界更坚定地承诺采用广泛可用的工具和措施，以提高研究质量。
