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Private Research

These international codes have been superseded by U.S. Department of Health and Human Services (HHS) regulations for most traditional institution-based research. They are still important for private research that is not done under HHS auspices. For example, pharmaceutical firms have always engaged in and contracted for private research. These firms have been criticized for testing drugs in Third World countries to avoid legal liability. In general, however, this research has been well designed and controlled to ensure that the resulting data will be acceptable to the U.S. Food and Drug Administration (FDA).

More problematic are independently run trials that implicitly promise therapeutic benefit from experimental drugs. Some of these trials are run on a money-making basis, allowing wealthy patients to buy access to experimental drugs. Others, such as certain clinics treating AIDS patients, are humanitarian efforts to increase access to experimental drugs. Both efforts have serious methodological flaws because they are dependent on self-selected populations with a high probability of manipulating their care outside the research protocol. This sample selection and compliance problem undermines the potential value of the research. At some point, the potential societal benefit of the research is so small that it is no longer ethical to conduct the research.

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