Regulating the research enterprise: international norms and the right to bodily integrity in human experiment litigation.

• Author: Lunstroth, John

ABSTRACT: This article analyzes international law claims in human subject litigation, arguing that the failure of federal courts or Congress to oversee this kind of litigation by providing or recognizing a federal cause of action for research torts is an injustice. It is about two distinct and somewhat arcane areas of the law, international law and the law of human subjects research. Because they draw on different historical, social and conceptual frameworks, each has its own descriptive section in the article. In the first section, the author briefly describes international law and its place in the U.S. constitutional order. This section explains why international law claims are routinely rejected by the courts. In the second section, the author discusses the moral underpinnings of the research enterprise and explains how the values of science contradict the values of human rights and medicine.

The author concludes that Congress or the judiciary should recognize the social magnitude of the research enterprise, the difference between the values of science and the values of medicine, and the meaninglessness of individual informed consent when considered on a population level. Citizens should be provided with a clearly defined cause of action for research harms to human subjects.

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The research enterprise, a federal level undertaking, is regulated by a federal statute that does not recognize a cause of action for individuals tortiously injured in an experiment. Claimants for such injuries frequently and unsuccessfully attempt to make international law claims in federal courts. In very limited circumstances federal courts recognize a violation of the Fourteenth Amendment due process right to bodily integrity, but for the most part the federal judiciary sends the cases into stare courts to be litigated under state-based physician malpractice laws.

Although there are not many human experimentation cases, this article attempts to make sense of the international law claims, arguing at the same time that the failure of federal courts or Congress to oversee this kind of litigation by providing or recognizing a federal cause of action for research torts is an injustice.

This article is about two distinct and somewhat arcane areas of the law, international law and the law of human subjects research. Because they draw on different historical, social and conceptual frameworks, each has its own descriptive section in the article. In part one, in the section entitled International Law, I briefly describe international law and its place in the U.S. constitutional order. This section explains why international claims are routinely rejected by the courts. In part two, in the section entitled Science and Medicine, I discuss the moral underpinnings of the research enterprise and explain how the values of science contradict the values of human rights and medicine.

In the first part of the article, I discuss normative issues by addressing a series of questions. Why is it ineffective, generally speaking, to plead international and federal causes of action for research harms? Would an explicit, new norm providing a cause of action for research harms be socially beneficial? Should it be a federal norm or a state norm? What would the norm look like? Is there an alternative to the development of an explicit norm?

In the second part, I discuss the federal regulation of the research enterprise. I begin with a digression on the social, moral and epistemological relationship between medicine and science (Science and Medicine). Research is undertaken by scientists, not physicians, and the meaning of this distinction plays an important role in the argument the research enterprise is structurally dehumanizing and degrading. I describe the therapeutic misconception, then go on to give a brief history of the development of the federal regulation of human experimentation, concluding with a discussion of the role of the institutional review board (IRB).

In the third part, I describe in detail the various legal arguments why the International Covenant on Civil and Political Rights (ICCPR), and its article 7, could be used to provide a cause of action by the federal judiciary ICCPR, article 7, is an explicit peremptory norm for human experimentation that defines violations of the norm as torture and/or cruel, inhuman and degrading treatment.

In the fourth part, I discuss some of the federal court opinions organized by cause of action taking into account the previous sections. In this part I discuss the role of dignity in international law, constitutional jurisprudence, and in science and medicine. Many claimants attempt to use a "right to [be treated with] dignity" as a cause of action in research litigation, but the claims are rejected. I explain why and make some suggestions about how the concept of dignity can be used in this context.

In the final part, I return briefly to two questions that frame the article. Given that the practice of science on the population is not the same as the practice of medicine, and that there are no federal or uniform stare norms protecting citizens from the practice of science, should the federal judiciary recognize an international human rights norm? If it does not, is the Fourteenth Amendment right to bodily integrity sufficient to offer protection if interpreted in light of the international norms? I conclude with some uncertainty regarding the first question, and with firm conviction regarding the second. Congress or the judiciary should recognize the social magnitude of the research enterprise, the difference between science and medicine, and the meaninglessness of individual informed consent when considered on a population level, and provide citizens with a clearly defined cause of action for research harms.

Overview of the Issues

International Law

When discussing the role of international law in the U.S. legal system, there are some global issues that are important to understand. International law applies to stares (countries) interacting with other states. When the U.S. acts on the international level, it acts as a sovereign toward other sovereigns subject to laws or norms that have either been agreed on, such as treaties, or it acts according to custom, or customary international law. Individuals have virtually no legal standing at the international level. (1) There is no document accepted as an international constitution that compares to the U.S. constitution (of any other state constitution). (2) There are sharp conceptual boundaries between international norms governing states, and domestic constitutional norms establishing the branches and form of government of a state. This structure gives rise to hierarchy of law questions. (3) When a stare acts, should it act under international norms or constitutional norms? Which normative regime should have priority and when? Most importantly, when can a citizen use an international norm in domestic courts for a domestic injury, if at all? If the domestic court allows the use of such a norm, it is acknowledging an extra-constitutional legal order. The possibility of the judiciary recognizing two legal orders leads to questions about the role of the judiciary in the constitutional order and the concept of rule of law. (4)

The role of the Article III judiciary in the U.S. constitutional separation of powers is to support the rule of law established by the U.S. Constitution, therefore what the Constitution says about the law of foreign relations, or how it recognizes and structures international law, limits judicial powers. The Constitution speaks, and has spoken, both through its words and through judicial interpretation of the words when Article III courts rule on cases. A full description of how the Constitution addresses the law of foreign relations is beyond the scope of this article; however, in short, it assigns various powers to each of the branches and, most importantly, it establishes the place of international law (law of nations) in the constitutional order in the Supremacy Clause, which states:

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the authority of the United Stares, shall be the supreme Law of the land; and the Judges in every Stare shall be bound thereby, any Thing in the Constitution or Laws of any Stare to the Contrary notwithstanding U.S. Constitution, Art. VI, Clause 2. Article I, Sec. 8 of the Constitution grants the following powers to Congress: "Section 8. The Congress shall have power ... [10] To define and punish ... offenses against the law of nations;...." Article II, Sec. 2 grants the following power to the President: "Section 2. The President shall ... [2] ... have power, by and with the advice and consent of the Senate, to make treaties...." Article III, Sec. 2 grants the judiciary judicial power over: "[1] ... all Cases, in Law and Equity, arising under this Constitution, the Laws of the United Stares, and Treaties made...."

The foregoing constitutional rule of law seems to unambiguously establish treaty law as the law of the United Stares, to give Congress the power to define offenses against international norms, to the President the power to make treaties, and to the judiciary judicial power over treaty law and U.S. law. It is obvious that the positive law expressed in the Constitution is not adequate as a regulatory scheme, but establishes a partial structure that has been over time filled in by judicial interpretation, Congressional acts and executive custom. It is into the lacunae in this constitutional scheme that we go in seeking to find or establish a positive or explicit norm giving individuals a federal cause of action for damages arising from human experiments.

There are two sources of international law that are of interest to human experiment litigants, treaty law and customary international...