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The goal of this section is not to review the medical legal history of medical experimentation or to discuss the workings of institutional review boards. These topics have been thoroughly discussed elsewhere (see references at the end of the chapter) and could not be adequately examined in the present context. Our goal here is rather to discuss the risk management consequences of medical experimentation and to show why the lack of litigation in the past should not lead health care providers to overlook the legal hazards implicit in such experimentation. Jay Katz has pointed up the legal and moral implications of medical experimentation in the following words:

What consequences ensue for society and subject if no external restraints are imposed on an investigator's utilization of human subjects for research purposes? Perhaps the most extreme example of experimentation without restrictions occurred in Nazi Germany. In the concentration camps "political," "racial," and "military" prisoners, considered unworthy of the protections ordinarily afforded to citizens of any society, were made available to physicians for research. This environment provided the investigators with an opportunity to carry out studies with unlimited freedom. In scrutinizing these materials from the vantage point of experimentation without restriction, we disregard their cultural origins and focus on those aspects which may offer insights relevant to our society.

The legal proceedings against the Nazi doctors at Nuremberg exposed in their starkest form the inherent conflicts between scientific interests and societal interests (seen as the interest of the world community). We do not suggest that other cases comparable to the concentration camp experiments in magnitude or cruelty can be found elsewhere in the literature. Yet examples from the pre- and post-World War II periods demonstrate that the actions of the Nazi physicians were not isolated instances of "crimes against humanity." Whenever subjects are too helpless or ignorant to resist participation, the investigator is in a position to pursue his scientific interests constrained only by his personal and professional conscience and values. Thus similar transgressions occurred prior to the Nuremberg trials and continue to occur, though because they are less dramatic their existence is more likely to be denied.

No area of medical law has spawned more writing, debate, and emotional commitment than human experimentation. The Nazi concentration camp experiments were terrifying because they illustrated the antithetical nature of medicine. These experiments were carried out not by madmen but by respected physicians and scientists. If the experiments had been a unique aberration of the Nazi mentality, they would not have left such a profound stamp on ethical thinking.

Unfortunately, the concentration camp experiments were a logical consequence of scientific inquiry being carried out in the absence of societal controls. Without such controls, medical research quickly put the search for knowledge ahead of the well-being of the experimental subjects. This fact is central to the successful supervision of medical experimentation. There must be constant monitoring and enforcement of ethical codes to prevent the research efforts from drifting into practices that would subject the health care provider to legal liability.

This is a very difficult position for the quality control manager to argue because there has been so little litigation over medical experimentation. The great legal dilemma is why such an emotionally charged issue had produced so little litigation. Medical scientists argue that it is due to the success of scientists policing themselves. If this were true, medical experimentation should not pose a significant problem for the quality control manager. However, medical experimentation must still be a concern for the quality control manager if the lack of litigation is due to factors that discourage litigation irrespective of whether patients have been injured by the experiments. Here, it is important to note that the scientific community is divided over the issue of whether significant numbers of persons are actually injured in medical experiments. There is no unbiased information available on this point, but our own experience is that injuries caused by medical research are a significant problem.


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