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The specter of the Tuskegee Syphilis Study inevitably looms over talk of human subjects in medical research. The well-known case involved the U.S. Public Health Service, which, from 1932 to 1972, studied hundreds of black men in Alabama with syphilis, failing to inform them of their diagnosis or treat their condition. From this striking example of a disregard for ethical standards and the lives of these men, many African Americans harbor deep suspicions about government-sponsored medical studies.

The Tuskegee experiments, however, are one of many disturbing cases over the field's history, in which tests were often performed on nonconsenting mental patients, prisoners, poor blacks and people overseas. Last year, when a Wellesley College professor unearthed hidden files detailing U.S. government experiments in Guatemala in the 1940s, where scientists infected hundreds of people with syphilis, President Barack Obama apologized to the Guatemalan government and people, vowing never to repeat the atrocities of the past.

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With that, Obama directed the Presidential Commission for the Study of Bioethical Issues to conduct a thorough review of the Guatemala experiments and current regulations for federal research. He asked the 13-member advisory council to assure him that federal laws effectively protect research participants, both domestically and abroad, from harm and unethical treatment. Its report is due to the president by September.

The bioethics commission held a meeting in Washington, D.C., this week to review the initial results of its investigation. The Root talked to commission member Anita L. Allen, a professor of law and philosophy at the University of Pennsylvania Law School, about U.S. medical studies performed in Africa and South America, the ethical concerns of conducting research in prisons and whether anybody is likely to get a government apology again.

The Root: U.S. clinical studies are increasingly conducted abroad, with a particular focus in sub-Saharan Africa and Latin America. Why are pharmaceutical companies targeting these parts of the world?

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Anita L. Allen: One motivation for doing human-subjects research abroad is that sometimes the needs for the clinical investigations are abroad — that is to say, some medical conditions are more common in developing countries than in the developed world. So the researchers are going where the need is. What we heard at the meeting this week is that developing countries are seen to benefit from having investigators internationally come in and conduct clinical trials.

TR: What are some examples of conditions that could not just as easily be researched on people in the United States instead of, say, Nigeria?

Another rationale we heard was cost. It can be less expensive to do research in a developing country than in the United States. However, we also heard the argument made that, sometimes, not counting some of the ancillary costs of research makes it appear that research abroad is cheaper. If researchers addressed all the social and medical needs of a population — their underlying, more holistic health concerns — then we might realize that research in these countries is more expensive than it seems. But people are looking for cost-effective places in which to do this very expensive research.

Unfortunately, to some extent it is also a lack of regard for the human rights of people in developing countries that may have prompted some researchers to seek out these domains for this research. We heard a combination of reasons.

TR: Now that you have this information, what is the commission doing next?

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.

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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.

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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?

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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].

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I'm not aware of any human-subjects study research going on in prisons today that's not primarily aimed at benefiting the prisoners, or studying the prison population in order to better understand the psychological and physical effects of incarceration. It's about improving the lives of people who are facing incarceration.

TR: Performing research on prisoners at all, though, can still feel ethically murky. It raises the question, how "voluntary" is it really if they're locked up?

ALA: Obviously, anyone who's behind bars is in a situation in which it's hard for them to make their own choices. But suppose someone in prison needed their tonsils out. Can a person in prison give informed consent to have their tonsils out? You might say, "No, because they're in prison!" Or you might say, "Of course they can because, although they're in prison, they can make their own choice about whether they want to have a tonsillectomy." It's too much to say that people in prison can't consent to anything, but there may well be some things that we don't want to ask people in prison to face giving consent to.

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Sometimes when people hear the words "human-subject research," they think it means something scary and invasive — some kind of surgery, something that involves the taking of body tissues, and things of that nature. But some of what goes under the name "human-subject research" is simply filling out a questionnaire. It can mean taking some blood for a blood test, filling out a form and going to an interview to be asked questions by a researcher. It's a whole range of things.

Actually, a sign of how far we've come is that, in universities all around the country where there's just survey-type research, there's an institutional review-board process that requires looking into issues of informed consent, privacy and so forth, even if it just involves someone filling out a form.

TR: Given the documentation of unethical experiments performed on prison inmates, mental patients and poor blacks in the past, do you anticipate there will be other forthcoming apologies on the government's behalf, as we saw in the Guatemala situation?

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ALA: The commission's work is not aimed specifically at recommendations concerning the relevance of an apology. However, everybody, from President Obama to the commission chair and vice chair, agrees that what we discovered happened in Guatemala was unethical. This is something we've been very open about, and there's a common understanding that what happened was wrong, and every effort would be made to ensure that such things do not happen again.

Cynthia Gordy is the Washington reporter for The Root.