Informed Consent in Right-to Try – A Dubious Assumption

Informed Consent in Right-to Try – A Dubious Assumption
Rebecca Dresser
Wake Forest Journal of Law & Policy, 2020; 11(1)
Open Access
In the debate over right-to-try, everyone agrees that the patient’s informed consent is essential. If individual autonomy is the justification 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 effective treatments.1 But these laws also present dangers to the patients who are their purported beneficiaries.2 Right-to-try supporters 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 requirements for informed consent. Part I reviews right-to-try statutes, focusing 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…

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