Regulating the Research Enterprise: International Norms and the Right to Bodily Integrity in Human Experiment Litigation

23 Issues L. & Med. 141 (2007)

80 Pages Posted: 12 Apr 2013

See all articles by John Lunstroth

John Lunstroth

UNESCO Chair in Bioethics and Human Rights; University of Houston

Abstract

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 14th Amendment due process right to bodily integrity, but for the most part the federal judiciary sends the cases into state courts to be litigated under state-based physician malpractice laws.

Although there are not many human experimentation cases, this paper 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.

In the first part of the paper I address 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. 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. I also discuss the use of international law to interpret constitutional rights, especially the 14th Amendment right to bodily integrity.

In the final part, I return briefly to two questions that frame the paper. 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 state norms protecting individual citizens from the practice of science, should the federal judiciary recognize an international human rights norm? If it does not, is the 14th 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.

Keywords: international law, human experimentation, ICCPR, torture, IRB, human rights, right to bodily integrity, dignity

Suggested Citation

Lunstroth, John and Lunstroth, John, Regulating the Research Enterprise: International Norms and the Right to Bodily Integrity in Human Experiment Litigation. 23 Issues L. & Med. 141 (2007), Available at SSRN: https://ssrn.com/abstract=2249140

John Lunstroth (Contact Author)

University of Houston

4800 Calhoun Road
Houston, TX 77204
United States

UNESCO Chair in Bioethics and Human Rights ( email )

2255 JEAN ST
HOUSTON, TX 77023-5008
United States
7134120077 (Phone)

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