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Abstract

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.