The voluntary consent of the human subject is absolutely essential.

Contrary to the first principle of the Nuremberg Code, the voluntary consent of the human subject is neither necessary nor sufficient for ethically and legally responsible research in the United States. That it is not sufficient has been well argued by Robert Burt and others. We would not say that the central problem of the Nazi experiments was their failure to obtain informed consent. Nor would the presentation of signed and witnessed consent forms change anyone's view on the moral justification for the experiments. For related reasons, institutional review boards (IRBs) sometimes reject or defer protocols for paternalistic or various other reasons, arguing that clinicians should not allow patients to consent to be subjects in a study.

Physicians have struggled to defeat alternative medicine, and to obtain a monopoly over the health care of their patients, since physicians began systematically organizing in the United States. They claim to oppose alternative medicine because it lacks efficacy, may waste precious health care dollars and may harm patients. Part II of this Article examines the ongoing debate about alternative medicine and the arguments that may wedge the door of Western medicine open to alternative treatment methods. Alternative medicine's successful entry into Western practice depends on convincing conventional medicine of the efficacy of alternative treatments, a task that remains largely undone. Part III explains why the debate about unproven alternative therapies differs from previous discussions about human research, and therefore merits independent consideration. Part IV argues that it is not ethically appropriate for physicians to offer or agree to provide alternative therapies whose efficacy remain unproven or are of dubious potential.

In the United States we have very mixed feelings about research with human subjects. The Nuremberg Code (the Code), which provides a foundation for the protection of human subjects, was written by American judges in the context of trying Nazi doctors who committed atrocious acts of human experimentation on concentration camp inmates. The Code provides ten common-sense guidelines controlling research. For example, a researcher may not conduct research on human subjects without that subject's informed consent, or if there is an a priori reason to believe that the research will cause death or disabling injury to the subject. What is remarkable about the creation of the Code is that it was thought to be necessary to document and impose the most fundamental moral principles on researchers. The Code demonstrates a remarkable suspicion of research with human subjects and those who perform such research.

This could be the world's largest friendly fire incident.

In his classic treatise On War, Karl von Clausewitz emphasizes that courage is the “first quality of a warrior.” He defines two types of courage: “courage in the presence of danger to the person; next, moral courage, or courage in the presence of responsibility, whether before the judgment seat of an external authority or before that of the internal authority of conscience.“ Both were involved in the U.S. military's decision to seek a waiver of informed consent requirements for the use of investigational drugs and vaccines on U.S. troops in the Persian Gulf War. The danger of chemical and biological attack was seen as demanding this waiver; while the Nuremberg Code, medical ethics, and respect for the human rights and dignity of American soldiers cautioned against it. The legal maneuvering to revise consent regulations for wartime conditions provides a case study illustrating how the boundary line between therapy and experimentation can become hopelessly blurred, the differences between law and ethics, and the ethical obligations of military physicians.

The body of the nineteenth century philosopher Jeremy Bentham is on display in a glass cage at University College, London. Bentham applied his utilitarian perspectives to the body by suggesting that corpses, including his own, would be of greater use to society stuffed and displayed as an “auto-icon” rather than simply buried away. Preserved, exhibited and studied, the corpse, he said, could serve “moral, political, honorific, dehonorific, money-saving, money getting, commemorative, genealogical, architectural, theatrical, and phrenological” ends.

There are a remarkable number of similarities between science and the law. Each discipline sets as a gold standard a search for precision. For example, scientists utilize the scientific method—a specific set of principles and procedures designed to aid them in a systematic pursuit of knowledge. Following the scientific method involves the recognition and formulation of a problem, the collection of data through observation and possibly experimentation, the formulation of a hypothesis and the testing and confirmation of the hypothesis formulated. The law, in turn, seeks its form of precision through the careful use of words, as in finely crafted statutes or regulations and contractual language that seek to eliminate the possibility of vagueness or confusion. Each discipline utilizes an approach or methodology that strives to minimize or eliminate the possibility of error and to arrive at a form of “truth” that it recognizes as being maximal within the confines of the rules it has established, be they rules of scientific method or legal rules of evidence.

After a decade of courtroom battles and heated academic debate, the United States has entered an age where the scientific validity of deoxyribonucleic acid (DNA) evidence is not subject to serious dispute. The problem with DNA evidence is no longer one of validity, but one of proficiency. Two confounding variables in the DNA testing process weaken and often destroy DNA's powerfulness and usefulness in the courtroom: crime labs and juries.

This Note proposes new and stringent standards for the admissibility of DNA evidence. The admissibility of forensic DNA evidence must be conditioned on its examination by a crime lab governed by uniform national standards. Such governing national standards must encompass every aspect of the forensic process, from chain of custody to DNA testing procedures, in order to ensure the reliability of DNA evidence. Implementing such a comprehensive national standard, however, only represents a first step toward solving the problem of DNA evidence in the courtroom. This step, however, fails to address the second problem facing the effective use of DNA in courtrooms: juries.

The Internet offers pharmaceutical companies and medical device manufacturers a dynamic new medium for promoting their products—a medium that might actually be better suited for health care product promotion than print or television. On the Internet's World Wide Web (Web) pages, drug and device makers can produce interactive marketing and advertising material that more easily complies with current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) disclosure requirements. Navigation buttons and hypertext links can facilitate compliance with such information disclosure requirements by allowing drug and device makers to “hide” the brief summaries or labels until interested viewers “click” on them.

Despite the appropriateness of the medium, however, a Web search today will turn up less drug and medical device promotion than one might expect. In fact, the Web, which represented $7 billion in commerce in 1997 and is expected to account for $20 billion in 1998, is strangely quiet on this front.