Extract
An open door to ending exploitation: accountability for violations of informed consent under the Alien Tort Statute.
INTRODUCTION I. CLINICAL TRIALS MOVE ABROAD--BUT HUMAN SUBJECTS PROTECTIONS DO NOT FOLLOW A. Utility of Extraterritorial Research to Multinational Corporations B. Utility of Medical Research to Developing Countries C. Inadequate Enforcement of an Informed Consent Requirement Permits Exploitation II. HUMAN SUBJECTS CAN ENFORCE PROTECTIONS UNDER THE ATS A. Trovan Litigation as a Test Case B. Judicial Interpretation of the ATS Leaves Room for Expansion of the Federal Common Law 1. Historical Perspective on the ATS 2. Filartiga and Tel-Oren 3. The Sosa Standard Defined: A Jurisdictional Statute Recognizing Federal Common Law III. INFORMED CONSENT MEETS THE SOSA STANDARD FOR A NORM OF CUSTOMARY INTERNATIONAL LAW A. Human Subjects Protections Require Informed Consent 1. Nuremberg Code 2. Declaration of Helsinki 3. CIOMS International Ethical Guidelines for Research Involving Human Subjects 4. International Conference on Harmonisation: Good Clinical Practices 5. United Nations Provisions 6. Convention on Human Rights and Biomedicine B. Informed Consent Is Universal, Definable, and Obligatory 1. The Mandate for Informed Consent is Universal 2. Informed Consent is Definable 3. The Norm of Informed Consent is Obligatory C. A Norm of Informed Consent Should Be Recognized Under the Federal Common Law D. Nonsubstantive Considerations in ATS Litigation 1. State Action Requirement 2. Forum Non Conveniens 3. Political Question Doctrine 4. Evidentiary Burdens CONCLUSION INTRODUCTION
In 1914 a New York court decided the seminal case that established an individual's right to informed consent. (1) The court opined that "[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body." (2) Almost a century later, however, a New York court effectively denied enforcement of that right to every human being outside of the United States when it declined to find jurisdiction under the Alien Tort Statute for a foreign violation of informed consent. (3) A 2005 film, The Constant Gardener, heightened public awareness of international violations of informed consent by exposing questionable tuberculosis experiments conducted on nonconsenting, HIV-infected patients in Africa and revealing the inability of these patients to escape experimentation in clinical trials if they wished to maintain later access to basic medical care. (4) With an increased demand for clinical trials to support the appropriateness of drugs, the number of clinical trials in developing countries (5) is likely to increase. (6) The above examples demonstrate the particular vulnerability of human subjects in developing countries, and the need for more rigorous protection of their rights in the international context. Notwithstanding recent circumstances in both fact and film, international consensus demands certain minimum protections for human subjects involved in research and considers deviation from those protections to be violations of human rights. Several international instruments describe protections for human subjects involved in clinical trials. These instruments, however, provide no formal remedy for harms resulting from a breach of the universal principles governing research ethics, including the right to informed consent. Some individual countries have attempted to formalize protections through regulatory measures designed to incentivize conduct consistent with the mandates of ethically acceptable research. (7) Yet inconsistent or nonexistent enforcement of these measures again leaves human subjects without any real protection. The inadequacy of judicial standards and regulatory enforcement in many developing countries has prompted human research participants to explore other means of enforcing their right to informed consent. The Alien Tort Statute (ATS) (8) provides a viable option for these individuals, although it has not yet been successfully employed for such a purpose. (9) This Comment argues that the ATS, in fact, provides the most promising remedy for an individual whose right to informed consent has been violated in a clinical trial conducted in a developing country. While there are significant barriers to succeeding on any ATS claim, these barriers are not unique to the situation considered here and should not preclude a plaintiff from bringing an action under the ATS. Part I examines the increasing globalization of clinical trials, and the need to protect human participants in these research endeavors. Part II describes the ATS and explores its reach over international torts after the U.S. Supreme Court's decision in Sosa v. Alvarez-Machain in 2004. (10) This decision restrained the growing applicability of the ATS to novel situations involving violations of human rights. Specifically, the Sosa Court addressed whether the ATS provided only a jurisdictional basis for a suit in a U.S. federal court or, more broadly, whether it permitted courts to establish a new cause of action for violations...See the full content of this document
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