Academic journal article Chicago Journal of International Law

Expanding Notions of Self-Determination: International Customs of Informed Consent in Medical Experimentation Pre-1945

Academic journal article Chicago Journal of International Law

Expanding Notions of Self-Determination: International Customs of Informed Consent in Medical Experimentation Pre-1945

Article excerpt

Table of Contents

I. Introduction..............147

II. Consent as Established Customary International Law............153

A. Customary International Law.............153

B. Understandings of Consent...........155

C. The Current State of Informed Consent..................158

III. Legal-Historical Analysis of Consent...............162

A. Early Conceptions of Consent.............163

B. Eighteenth Century.............164

C. Nineteenth Century...........166

D. Twentieth Century............171

IV. Assessing Consent in Light of Nuremberg............181

A. Background Information.................181

B. The Testimony of Werner Leibbrandt..............181

C. The Testimony of Dr. Andrew C. Ivy.............182

D. The Impact of the Testimony.............183

V. Establishing Customary International Law Based on The Preceding Historical Analysis.......................185

VI. Conclusion.......................................187

I. Introduction

In 2010, former United States President Barack Obama issued an apology for unethical experiments conducted by the U.S. government in Guatemala.1 During the course of an experiment funded by the National Institutes of Health, officials conducted research on over five thousand vulnerable Guatemalan people-without their consent.2 At least 1,308 individuals were deliberately infected with sexually transmitted infections (STIs).3 The public had no knowledge of the experiments, which began in 1946, until a historian uncovered the archived papers of the medical officer who conducted them, Charles Cutler, more than half a century later.4 On August 20, 1947, the Nuremberg Doctors' Trial found seventeen physicians guilty of crimes based on the non-consensual nature of experiments conducted on individuals imprisoned in concentration camps. Despite the highly-publicized outcome of the trial, the non-consensual experimentation conducted by Charles Cutler did not end until December 1948, and the follow-up work continued through 1953.5

While the atrocities exposed at the Nuremberg Trials led to a collective declaration of "never again,"6 there had been, and would continue to be, numerous instances of non-consensual human experimentation despite what I will argue is an already-existing requirement of consent.7 During the same period, American physicians exploited black farmers in Tuskegee,8 Japanese researchers violated the autonomy of prisoners of war,9 and Canadian pediatricians starved aboriginal children as part of nutritional studies."' Experiments, both preceding and succeeding the Nuremberg Trials, have illuminated tensions between various competing values-mainly, scientific inquiry, medical advancement, and respect for subjects." At the intersection of these values, the law has grappled with its role in human experimentation.

Over time, one of the primary legal doctrines that developed around human experimentation was the principle of informed consent.12 Despite its prominence in both legal and bioethical studies, the specific contours of informed consent remain contested and the subject of spirited debate.13 Notwithstanding this uncertainty, in the case of the 1946 Guatemala STI experiment, a U.S. district court found that "there [was] no doubt" that the government "engaged in nonconsensual human experimentation."14 The district court found that nonconsensual medical experimentation violates customary international law.15 In its order, the district court cited Abdullahi v. Pfizer, Inc.,™ where the Second Circuit determined that the authority for the international custom of informed consent was found in The Nuremberg Code, the World Medical Association's Declaration of Helsinki, the guidelines of the Council for International Organizations of Medical Sciences, and Article 7 of the International Covenant on Civil and Political Rights.1 Regardless of this relative clarity, the history of nonconsensual experimentation that predates these devices raises a significant question: was the custom of consent established prior to the Nuremberg Trials? …

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