1. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators Publication: [Silver Spring, MD] : Oncology Center of Excellence, June 2020 Subject(s): Biological Products -- therapeutic useCOVID-19 -- drug therapyDrugs, InvestigationalEthics Committees, ResearchUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.