Somewhere to Run, Somewhere to Hide? International Regulation of Human Subject Experimentation

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INTRODUCTION

The pharmaceutical industry is one of the most important players in the field of clinical research on human beings. Increasingly in recent years, "Big Pharma" in the United States and elsewhere has turned to foreign populations to test its new products. The purpose of this note is to examine how existing sources of quasi-legal and ethical regulation address the troublesome issues raised by this increase in international human experimentation. First, the note gives a brief history of human experimentation and its regulation, giving special focus to the events of the twentieth century that have most affected the development of the bioethics movement. Next, it describes and compares several instruments of international regulation of human subject experimentation. Finally, it examines some of the difficult ethical issues associated with international research on human subjects. In this discussion, the greatest amount of attention will be given to clinical trials performed by the pharmaceutical industry. Other types of international research on human subjects exist, but research by the pharmaceutical companies poses its own special regulatory and ethical problems.

I. HISTORY AND BACKGROUND

A. Pre-Nuremberg

Though the Holocaust and the concurrent Nazi experimentation on prisoners and Jews (1) brought unprecedented attention to experiments on human subjects, such experimentation and ethical reflection thereon began much earlier. One of the earliest codes of medical ethics was the Hippocratic Oath. (2) The Hippocratic Oath's focus is on care that directly benefits the patient; however, as in many early documents regarding ethics and human experimentation, that benefit is determined by the doctor and not the patient. (3) While the oath does not directly address human research, (4) the issue of delegating decision-making to physicians arises in later international codes and agreements on human experimentation.

Perhaps as a result of the lack of attention to human subject research, experimentation continued unabated and largely unregulated until the 19th century. (5) In 1803, Thomas Percival, an English physician, promulgated a code of medical ethics that dealt directly with human experimentation. (6) Like the Hippocratic Oath, Percival's code is decidedly skewed towards the interests of physicians and experts. There is no mention of consent or other protections of human subjects] The first American code of ethics dealing with human experimentation was created by William Beaumont in 1833. (8) The most important aspect of Beaumont's code, in comparison with that of Percival, is that it recognizes the necessity of the subject's voluntary consent and requires that experimentation cease if, at any time, the subject is "distress[ed]" or "dissatisfied." (9) In 1865, the French physiologist Claude Bernard published his own guidelines governing human experimentation, which precluded any human experimentation that would not be of direct benefit to the patient, no matter its value to science. (10) However, the valuation of that benefit remained in the discretion of the physician.

Ironically, one of the first official regulations of human experimentation came out of the Prussian government in 1900, (11) which was then part of the German Empire. (12) The Prussian directive expressly prohibited non-therapeutic research either on incompetent individuals (including children) or where the subject had not given "unequivocal[]" consent to the procedure after having it explained to him. (13) Historical records and contemporary press reports show that these guidelines were largely ignored by German medical researchers throughout the decades between their promulgation and 1931--when new guidelines were introduced. (14) These new guidelines were generated by the Reich Health Council and published by the Reich Minister of the Interior in response to reports of lax ethical standards among German medical researchers. …