Ethics

Protection of Human Subjects

For practitioners of health services research, probably the most important ethical questions have to do with how to conduct their work without violating customary or legal standards of behavior. In evaluating health services outcomes, it would be useful to be able to randomly assign patients to treatment and control groups, but this cannot be done without due consideration given to the rights of the people involved. The study of best practices would benefit from being able to observe the natural history of diseases, but society does not allow this to be done without the informed consent of those being observed.

There are certain touchstones that need to be acknowledged if one is interested in understanding the history of protection of human subjects of research. Among these are the Tuskegee syphilis study and the Belmont Report. In the 1930s, a group of researchers from the U.S. Public Health Service (PHS) decided that they would closely observe a group of African American men diagnosed with syphilis to determine the natural history of the disease in Black men. The men were not offered treatment, even when, a few decades into the study, modern antibiotics became available.

Today, society looks aghast at this violation of the dignity of these men, treated as not much more than animals to be observed rather than patients to be served. Failing to discuss the goals of the study and secure the participants' permission was a violation of the men's autonomy, their right to determine their own future. The researchers did not treat these men, thereby failing to provide them the beneficence that is the hallmark of healthcare. Deciding to do without life-saving treatment when it became available was an obvious violation of the value of nonmaleficence. And it is impossible to avoid the injustice of these actions, perpetrated on an underprivileged minority; justice demands that those who might bear the risks of an experiment be among those who could benefit from the results. These four principles—autonomy, beneficence, nonmaleficence, and justice—form the basis of most contemporary discussions about the need to protect human subjects involved in health-related experiments.

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