Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines [June 2, 2020]   [open pdf - 708KB]

From the Document: "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 stakeholders--sponsors, IRBs, and FDA--aim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions that are heightened during a worldwide pandemic. Existing law requires FDA and IRBs to weigh these considerations when evaluating proposed clinical trial designs for COVID-19 vaccines. This Sidebar describes the legal and regulatory framework that governs clinical trials for pharmaceutical products, such as vaccines, and some avenues researchers and Congress may consider for accelerating that process during the COVID-19 pandemic. (For ease of reference, this Sidebar uses the term 'drugs' includes both traditional drugs and biological products, including vaccines.)"

Report Number:
CRS Legal Sidebar, LSB10483
Public Domain
Retrieved From:
Congressional Research Service: https://crsreports.congress.gov/
Media Type:
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