Realizing Informed Consent in Times of Controversy

17 Pages Posted: 22 Sep 2016 Last revised: 26 Sep 2016

See all articles by Robin Fretwell Wilson

Robin Fretwell Wilson

University of Illinois College of Law

Robert Morse

Independent

Date Written: September 22, 2016

Abstract

This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the trade-offs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”

Suggested Citation

Wilson, Robin Fretwell and Morse, Robert, Realizing Informed Consent in Times of Controversy (September 22, 2016). Journal of Law, Medicine and Ethics, No. 44, 2016; Illinois Program in Law, Behavior and Social Science Paper No. 16-36. Available at SSRN: https://ssrn.com/abstract=2842319

Robin Fretwell Wilson (Contact Author)

University of Illinois College of Law ( email )

504 E. Pennsylvania Avenue
Champaign, IL 61820
United States
217.244.7582 (Phone)

HOME PAGE: http://www.robinfretwellwilson.org

Robert Morse

Independent ( email )

No Address Available

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