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

Issues in Law & Medicine, Fall, 2007 by John Lunstroth

Distinguishing Legal from Ethical Norms

Subject plaintiffs routinely try to raise federal claims in addition to their state claims. Federal claims generally fall into two categories. In the first category are claims under 42 USC [section] 1983 alleging violations of Fourteenth Amendment substantive and procedural due process rights; claims that subjects are third party beneficiaries of the assurance agreement between the Department of Health & Human Services and the research institution; claims either directly under the Common Rule, or under 42 USC [section] 1983 alleging violations of rights created under the Common Rule. The second category of claims arise under or derived from international documents. They include claims made under the Nuremberg Code, the Declaration of Helsinki, the International Covenant on Civil and Political Rights, and the putative human right to dignity. It is these claims that are the subject of this article.

Of the norms said to be international law, only the ICCPR, art. 7. has status as law. The Nuremberg Code, the Declaration of Helsinki, the CIOMS Code, the Belmont Report and other similar documents on their face only provide ethical standards and none of them are implemented as legal norms in any legal document.

The ICCPR is one of the fundamental international human rights treaties. Its use in U.S. courts is complicated by the terms under which the U.S. ratified the treaty, and because the federal courts give great weight to the statements of the executive concerning the intended uses of international law in U.S. courts. To summarize what I will discuss in greater detail below, the signing statement of the U.S. has "reservations, understandings and declarations" that explicitly make clear the U.S. government, in executing the treaty, had no intention of conferring on U.S. citizens any causes of action under the substantive human rights provisions of the Covenant. Furthermore, the executive, especially in the Bush administration, has adopted a very aggressive policy against the use of international legal norms in U.S. courts. The ICCPR is of great interest in this context because it enunciates a very clear norm regarding human experimentation: "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation." ICCPR, Art. 7.

There are several significant aspects to this norm. It is, above all, the nonderogable, jus cogens norm against torture. The norm forbidding torture is one of the most fundamental norms governing human societies. The assumption of the norm that scientific or medical experimentation without "free consent" is torture spreads a normative field over a significant portion of the health sector that now operates under neo-liberal norms that construe the idea of informed consent very weakly because it is an impediment to economic progress.

It is obvious that the ICCPR norm is not only legally important, as it fills a gaping hole in U.S. positive law, it is morally and rhetorically very powerful. It represents a vision of human dignity that is in important ways foreign to U.S. sensibilities, (15) and foreign to the moral framework of the U.S. regulation of human experimentation. (16) That being said, one must ask, do existing U.S. federal norms do the essential work being asked of them? Several U.S. district courts have applied the Fourteenth Amendment substantial due process right to bodily integrity in human experimentation cases. (17) Although its application in the experimentation context can be poorly understood and uneven, (18) does the fact of its use in this context confirm the idea that U.S. citizens do not need to use international norms in U.S. litigation because our civil rights, although not as fully articulated as international human rights, provide a robust enough conception of rights and a means of enforcing them?