by Congressman Christopher Smith

Since the Nuremberg trials, the image of humans used as laboratory animals has been etched into America's, if not the world's, cultural psyche. The Nazi atrocities prompted creation of the Nuremberg code of universal medical ethics. America's laws, modeled on this code, strictly forbid experiments on humans without obtaining their informed consent. But that recently changed.

Americans typically are trustful that they will not be used as human guinea pigs. This explains why Americans were so outraged a few years ago when they learned of syphilis experiments on black men in Tuskegee beginning in the 1940s who did not give their consent. It seemed inconceivable that such a thing could occur in our own country. Despite these deeply disturbing disclosures, however, the government recently relaxed the ethical code for research. The Food and Drug Administration issued a new rule last October that allows human experiments on patients without their consent.

The stated goal of the new regulations is to permit medical advances in treating life-threatening conditions when current treatments are either unproven or prove useless. A commendable goal, however, is little comfort to those individuals who find they have been experimented on without their consent. The primary motivation for the rule is not to help the patients experimented on, but to collect data. While FDA points out that the experiments may help patients, they also may hurt them. The Nuremberg code clearly places the patient's welfare as the overriding consideration in medical procedures.

Experiments on humans can help doctors develop better ways to treat illnesses. And that is why FDA relaxed the rule. But Dr. Arthur Dyck, professor of Population Ethics at Harvard University, points out that this new regulation risks "some very troubling dangers ... The Nuremberg code said there must be consent, and for darn good reason."

Under the new rule, researchers may conduct experiments on anyone, including fetuses, prisoners, and pregnant women. FDA argues that its system is very protective of patients. For instance, the government is setting up an institutional review board (IRB) that will "ensure that risks to subjects are minimized." But any risks beyond standard care appropriately should only be made by the patients themselves.

To complement the IRB, the agency establishes procedures to consult with representatives from patients' communities. But these precautions do not address the potential concerns of the individuals themselves. Typically, IRB and community representatives will not know the incapacitated individual. Indeed, these people likely will be preselected from the pool of those who believe these kinds of experiments are acceptable. Else the rule would be meaningless.

At the heart of this rule is the basic question who decides whether a person with "diminished autonomy" may be included in human experimental research? Dr. Dianne Irving, a former biochemist at National Institute for Health and a Ph.D. medical ethicist at DeSales School of Theology says there is an inherent conflict between advancing the interests of the patient and those of science, especially "if the doctor who is doing the research is also giving the permission" to use experimental technology on the patient. And that is what may happen here.

In the past, researchers needed the consent of a legal guardian. But under the new rules, researchers may waive this requirement is it is not feasible to contact them, or the window for decision-making is short. Any researcher who does so is supposed to obtain the consent of a family member. But again, the researcher can waive this if not feasible. And if a family member refuses, the researcher is not prohibited from proceeding if he finds another family member who consents. Although the final rule requires researchers to detail their efforts to contact guardians or family members if they proceed without contacting them, this is an after-the-fact justification by the researcher that is difficult to verify.

FDA specifically refused to establish any independent "ombudsman" to verify - before the patient's rights are waived - whether efforts to contact guardians or family members were adequate, or whether the patient is adequately protected. This leaves the decision to the researcher, and that may also be a conflict.

The vast majority of researchers are decent, honorable people dedicated to serving society. But the Nuremberg code of universal medical ethics exists to prevent those few self-serving researchers from taking advantage of patients unable to protect themselves. It also protects them from honorable researchers who may become blinded to the concerns of the patient in their eagerness to explore potentially life-saving therapies. The simple fact remains that we as Americans have a right to receive standard care in emergency situations. And we have the right to determine for ourselves what life saving procedures are preferable. Regrettably, the FDA regulations may compromise these rights.

Christopher Smith is a member of the U.S. House of Representatives, where he chairs the International Relations Subcommittee on International Operations and Human Rights.