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The Code Today

lthough it took decades to gain wide acceptance, the Nuremberg Code exerts a profound influence on the conduct of medical research today. An excellent example is the recent ruling by the Food and Drug Administration (FDA) governing research in the emergency room.

Because standard treatments for some conditions, such as head injuries, are ineffective, doctors want to try experimental drugs and devices that they consider promising, based on laboratory work and animal testing. But many emergency room patients suffering from these conditions are unconscious and relatives may not be present. The inability to obtain consent has slowed the pace of vitally needed research.

The FDA ruling permits researchers to enroll patients with life-threatening conditions in certain studies even if they are unable to grant voluntary informed consent, but only if they have informed the community that such studies are going on and that anyone who is admitted to the emergency department with a serious condition could be assigned as a subject. While media accounts have portrayed the FDA decision as a step back from the principle of informed consent, the fact that the agency had to make an explicit exception shows the tenacity with which we now embrace it. The ruling represents one step in the continuing effort to walk the fine line between medical progress and human rights.

The Nuremberg Code also contributed to a sea change in public attitudes toward research, which in turn has spurred debate over access to experimental treatments. It took decades to develop a consensus within the medical community that even ordinary science conducted by well-meaning researchers can lead to unintended harm. Today a system of carefully designed regulations protects desperate people from medical experiments that might only make them worse. In fact, the protections built into the system are so successful that people have become confident of low risks and high benefits if they are granted access to experimental drugs.

In the 1980s, AIDS activists mounted a series of successful campaigns to broaden access to experimental drugs such as AZT. Similarly, women of reproductive age, who were systematically excluded from many drug trials following the thalidomide tragedy of the early 1960s, have sought to participate equally in research in order to capture the potential benefits of experimental treatments and ensure that drugs or devices are developed to meet their needs. For instance, women excrete medications at different rates than men, and since women are more likely than men to use prescription drugs, advocates have argued that they should be better represented in research studies.

Today, concern about informed consent in medical research is greater than ever. In response to the uproar over the Cold War radiation experiments, President Clinton recently announced that henceforth all secret human research conducted in the name of national security would be subject to the rules of informed consent, and that scientists would reveal the names of the sponsoring agencies to participants. What’s more, Clinton’s advisory commission on bioethics, appointed last year, will undertake a review of current practices and requirements regarding the use of human subjects. In particular, the commission should address ways to ensure that voluntary consent is meaningful.

For instance, there is evidence that seriously ill patients often overestimate the likelihood that they will benefit from experimental treatments. Early trials of a new drug may be designed to determine its effects on the body, such as the rate at which it is excreted-not whether or not it is likely to cure the patient. In fact, most experimental treatments don’t work. In order for consent to be truly voluntary, the commission should require that sick patients receive counseling to ensure they understand the implications of research for themselves.

Another issue confronting the commission is whether states should enable people to declare in advance of a serious illness and loss of capacity their willingness to be a research subject in a study that might help them. At least some people who may be candidates for emergency-room research might be willing to make such an advance declaration. This measure would enable researchers to continue to investigate experimental emergency-room treatments without relying so heavily on unconsented research.

The principle of informed consent continues to pose new dilemmas for medical science. It is not always easy to find the balance between human rights and scientific progress. Yet the simplicity and intuitive force of the ideas articulated in the Nuremberg Code ensure their lasting moral relevance.

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