An Open Door to Ending Exploitation: Accountability for Violations of Informed Consent under the Alien Tort Statute

Abstract

INTRODUCTION 232 I. CLINICAL TRIALS MOVE ABROAD—BUT HUMAN SUBJECTS PROTECTIONS DO NOT FOLLOW 235 A. Utility of Extraterritorial Research to Multinational Corporations ......236 B. Utility of Medical Research to Developing Countries 241 C. Inadequate Enforcement of an Informed Consent Requirement Permits Exploitation 242 II. HUMAN SUBJECTS CAN ENFORCE PROTECTIONS UNDER THE ATS 246 A. Trovan Litigation as a Test Case 247 B. Judicial Interpretation of the ATS Leaves Room for Expansion of the Federal Common Law 248 1. Historical Perspective on the ATS 250 2. Filartiga and Tel-Oren 252 3. The Sosa Standard Defined: A Jurisdictional Statute Recognizing Federal Common Law 254 III. INFORMED CONSENT MEETS THE SOSA STANDARD FOR A NORM OF CUSTOMARY INTERNATIONAL LAW 255 A. Human Subjects Protections Require Informed Consent 257 1. Nuremberg Code 257 2. Declaration of Helsinki 259 3. CIOMS International Ethical Guidelines for Research Involving Human Subjects 262