Regulatory flexibility for COVID-19 research
Regulatory flexibility for COVID-19 research
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DOI：
10.1093/jlb/lsaa057
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发表时间：
2020-01-01
影响因子：
3.4
通讯作者：
Largent, Emily A.
中科院分区：
文献类型：
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作者：
Lynch, Holly Fernandez;Dickert, Neal W.;Largent, Emily A.
临床研究对抗击COVID-19至关重要，但在大流行情况下，对人类受试者保护的监管要求有时可能构成挑战。尽管监管机构在大流行期间为研究提供了一些有用的指导，但我们发现了有关机构审查委员会（IRB）审查和批准、知情同意、紧急研究和涉及监禁人员的研究的进一步合规挑战。我们在这些领域的监管灵活性的建议寻求满足保护参与者和促进高质量证据的发展，以改善病人护理的目标。这些建议可能具有超越COVID-19大流行的相关性，以更广泛地提高研究监督和参与者保护的效率。
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.