Narrat Inq Bioeth. 2021;11(1):39-45. doi: 10.1353/nib.2021.0019.
The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.
过去一年多来,SARS-CoV-2 大流行几乎影响到了全球生活的方方面面;临床研究实践也不例外。临床研究人员试图开展或继续开展与疾病本身相关或不相关的工作,他们面临着伦理、监督或监管方面的挑战。临床试验企业的各个方面都受到了影响。这些叙述详细描述了所遇到的一些障碍以及研究人员如何应对(或没有应对)的情况。出现了一些共同的主题,从想要做出贡献的愿望,到对实际和感知到的障碍(新旧障碍)的沮丧。这些叙述揭示了与大流行期间研究相关的常见伦理问题:与其他人类主题研究在质量和数量上都不同的问题;新的和新颖的挑战,以及以前见过的,但在危机面前更加突出的问题。这些叙述还提供了来自一线的建议,并谈到了大大小小的成功,以及团队合作和专注于共同目标的价值。