Rothwell Erin, Brassil Donna, Barton-Baxter Marietta, Brownley Kimberly A, Dickert Neal W, Ford Daniel E, Kraft Stephanie A, McCormick Jennifer B, Wilfond Benjamin S
Department of Ob/Gyn, School of Medicine, University of Utah, Salt Lake City, UT, USA.
Rockefeller University, New York, NY, USA.
J Clin Transl Sci. 2021 Apr 7;5(1):e105. doi: 10.1017/cts.2021.401.
In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.
在本文中，我们通过考察临床与转化科学奖（CTSA）机构内部的经验，探讨了新冠疫情如何影响临床研究的知情同意。我们首先简要概述了知情同意以及新冠疫情之前存在的挑战。然后，我们讨论了如何修改或改变知情同意流程以应对疫情，思考从中吸取了哪些经验教训，并提出为未来研究和公共卫生危机做准备的研究及政策措施。CTSA机构的经验和挑战为审视我们对知情同意的认识以及确定改进同意流程的下一步措施提供了重要视角。
