id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-334847-lf1grybz	Lynch, Holly Fernandez	Regulatory Flexibility for COVID-19 Research	2020-07-07		.txt	text/plain	2019	100	38	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 IRB review and approval, informed consent, emergency research, and research involving incarcerated people. Strict regulatory compliance may be challenging amidst a public health emergency, but participant protection and high-quality science remain essential.(1) In recognition of these considerations, FDA and the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) have issued guidance on conducting research during the COVID-19 pandemic.(2) Although this guidance offers a helpful start, gaps remain and additional regulatory flexibility is warranted in some instances. To ensure that this research proceeds efficiently and ethically, we offer suggestions to proactively address regulatory compliance challenges regarding IRB review and approval, informed consent, and inclusion of vulnerable populations.	./cache/cord-334847-lf1grybz.txt	./txt/cord-334847-lf1grybz.txt