[20200602]LSB10483_测试测试（阶段）1-2-3：潜在2019冠状病毒疾病疫苗临床试验的法律考虑.pdf

CRS Legal Sidebar Prepared for Members and Committees of Congress Legal SidebarLegal Sidebari i Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines June 2, 2020 In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential COVID-19 vaccines in clinical trials. Clinical trials are used to assess whether a new pharmaceutical product, such as a vaccine, is safe for humans and effective in achieving its intended purpose. Companies must generally test new pharmaceutical products on humans through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to market the product. But using human subjects to test these novel products exposes them to unknown health and safety risks, raising ethical considerations for FDA and for the sponsors and Institutional Review Boards (IRBs) overseeing the investigations. These stakeholderssponsors, IRBs, and FDAaim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions t