The Lingering Questions About Human Medical Experiments

The lessons of Tuskegee and Guatemala have a presidential commission reviewing how the government protects vulnerable test subjects. A committee member explains the ugly past and the safeguards in place now.

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ALA: Our commission has been asked, with specific respect to the Guatemala incident, to look at the circumstances under which that research took place. In that study we will be looking at the underlying causes and context of past atrocities.

We are also looking prospectively at how contemporary regulations and laws in the United States might prevent such things from happening again. The commission will be looking toward ensuring that, from a policy point of view, we have in place the rules and standards we need to make it unlikely that federally funded research would ever be used for a horrific purpose in the future.

TR: What are the current policies that are designed for this purpose?

ALA: There are federal ethical standards today that have been in place since Guatemala happened. Those standards apply to all federally funded research, no matter where it takes place. Those standards also apply to all human-subject research in the United States, whether it's federally funded or not.

One important standard is informed consent. That means that the researcher is obligated to disclose the risks and benefits of the research, and then to get the person's permission to, in light of those risks and benefits, go forward.

A second important condition is that the privacy and confidentiality be protected. Third, there's a requirement for an institutional review board. This requires that there be a group of people convened whose purpose it is to examine the research protocol and to ensure that the safety and rights of the research subjects are protected in the course of the research.

TR: In terms of clinical trials in the United States, studies continue to be done on volunteers in the federal prison population. What kind of research is this exactly?

ALA: There are several reasons a researcher might wish to turn to a prison-based population today. One reason is they may want to study the specific effects of incarceration. There may be research that relates to the condition of incarceration, in which case people who are or have been incarcerated would be the most apt human subjects to study.

While this is not something that anyone on the commission would condone, another reason is that if you have a prison population, the attrition rate in your study will be somewhat less. Whenever you're doing research, there's a certain amount of attrition in the study -- people may decide to withdraw from the study, or you might lose track of them. Well, it's easier to keep track of people who are incarcerated.

But I think the primary reason today is to benefit people in prison. In the past -- we're talking about 30, 40 years ago -- it was about having a ready population of people who were captive, people you might not have to pay and you might not have to [get] the same level of informed consent [from].