欢迎

Kalpana Beesabathuni, M. Grant
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引用次数: 0

摘要

临床和非临床人类受试者研究的最新情况:国内临床和非临床人类受试者研究项目不再需要与COVID相关的标准操作程序(sop),这些项目有irb批准的要求,要求参与者在进行研究前72小时内完全接种疫苗或接受阴性COVID检测。否则,sop仍然是必要的。鉴于有大量的协议需要修改,IRB只能在您的电子协议的年度续订时或当您提交不相关的修改时进行这些更改。
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Welcome
Update on Clinical and Non-Clinical Human Subject Research: COVID-related standard operating procedures (SOPs) are no longer needed for domestic clinical and non-clinical human subjects research projects that have an IRB-approved requirement for participants to be fully vaccinated or receive a negative COVID test within 72 hours before the research is conducted. Otherwise, SOPs continue to be necessary. Given the large number of protocols to be modified, the IRB can only make these changes at the point of the annual renewal of your eProtocol or when you are submitting an unrelated modification.
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