Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.

中文翻译：

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COVID-19研究的法规灵活性。

临床研究对于抵抗COVID-19至关重要，但是在大流行情况下，保护人类受试者的法规要求有时会带来挑战。尽管监管机构为大流行期间的研究提供了一些有用的指导，但我们发现在机构审查委员会（IRB）的审查和批准，知情同意，紧急研究以及涉及被监禁人员的研究方面，还有其他合规挑战。我们在这些领域的监管灵活性提案旨在满足保护参与者和促进开发高质量证据以改善患者护理的目标。这些建议可能在COVID-19大流行之外具有相关性，以更广泛地提高研究监督和参与者保护的效率。