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11 Wake Forest J. L. & Pol'y 1 (2020-2021)

handle is hein.journals/wfjlapo11 and id is 1 raw text is: INFORMED CONSENT IN RIGHT-TO-TRY-A DUBIOUS ASSUMPTION REBECCA DRESSERt In the debate over right-to-try, everyone agrees that the patient's informed consent is essential. If individual autonomy is the justi- fication for giving patients access to experimental interventions, then adequate understanding must be part of the process. To make autonomous choices, patients must compare the potential harms and benefits of investigational drugs to their other medical options. Is it possible for patients to make informed decisions in the right-to-try context? Will patients make autonomous decisions about trying investigational drugs when expert oversight is absent? Much of the critical commentary on right-to-try laws focuses on the damage the laws could do to other patients in need of safe and ef- fective treatments.1 But these laws also present dangers to the pa- tients who are their purported beneficiaries.2 Right-to-try support- ers claim that patient autonomy underlies their crusade, but they have done little to ensure that patients actually understand the choices these laws allow them to make.' This article examines the deficiencies in right-to-try require- ments for informed consent. Part I reviews right-to-try statutes, fo- cusing on the federal right-to-try law that was adopted in 2018. This part also compares the informed consent provisions in right-to-try laws with informed consent provisions in two other laws authorizing patient access to experimental interventions: federal law governing participation in human subject research and the Food and Drug Administration's (FDA) Expanded Access Program. t Rebecca Dresser is the Daniel Noyes Kirby Professor of Law Emerita at Washington University in St. Louis. Thanks to Alison Bateman-House for reviewing and commenting on an earlier draft of this article. 1. See Brandon Brown et al., Assessment of the Right-to-Try Law: The Pros and Cons, 59J. NUCLEAR MED. 1492 (2018). 2. Id. 3. See id. at 1493. 1

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