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President's commission begins review of research protections
Investigation comes in wake of discovery of past abuses in Guatemala
A presidential commission has begun carrying out President Barack Obama's charge to review human subjects protections in U.S.-sponsored research both here and abroad, in the wake of revelations about unethical research carried out in Guatemala in the 1940s.
In November, Obama asked the Presidential Commission for the Study of Bioethical Issues (PCSBI) to convene a special panel to investigate the Guatemalan research, as well as current protections for research participants both domestically and internationally.
Plans for the nine-month investigation still are in their early stages, says Hillary Wicai Viers, communications director for the commission. "We expect to announce plans in the near future for how we will convene the panel he's requested, and we hope to expand beyond the PCSBI as we convene that group."
Viers says the commission will hold a series of public meetings to elicit comments on the topic, and will accept written comments at its website, www.bioethics.gov
In the Guatemala study, U.S. Public Health researchers deliberately attempted to infect prisoners and mental patients with syphilis in order to see if penicillin could be used to prevent infection. The public health doctor who led the study, John Cutler, would later go on to play an important role in the Tuskegee syphilis study, which observed African-American men who had the disease without treating them.
One important difference between the earlier research and contemporary studies is that human subjects research now must be reviewed by people outside the research team, including IRB members, says Nancy Kass, ScD, Phoebe R. Berman professor of bioethics and public health in the Johns Hopkins Berman Institute of Bioethics, Baltimore, MD.
Despite that, Kass says it's important that the government undertake this review.
"If our government were to say, 'We already developed rules 35 years ago, nobody needs to pay attention to this,' I think it would send a really inappropriate message about how seriously the government takes this," she says. "And it would be a lost opportunity to use this teachable moment to once again underscore our foundational commitments to human beings in the pursuit of science."
Susan Reverby, PhD, the historian at Wellesley College in Wellesley, MA, who first uncovered evidence of the Guatemalan study last year, says she believes it holds lessons that apply to research done today.
"What was done was unethical, but also considered relatively normative," Reverby says. "Partially the lesson is to remember that even though we wouldn't let something like this happen now, what are we doing now that in 50 or 100 years, people will say, 'My God, you let people do that?'"
Obama's memo to the commission outlining his order for a review does not go into detail about what specific elements should be investigated. However, he emphasizes that the commission should "seek the insights and perspective of international experts, including from Guatemala; consult with its counterparts in the global community; and convene at least one meeting outside the United States."
That could lead to a fuller discussion of ethics in international research, including topics such as what is owed to developing countries and its citizens who participate in studies. It's a discussion that Reverby welcomes.
"I would really want to hear from different sides on this debate about the international aspects," she says. "I think it's time to revisit that debate."
Reverby also would like to see discussion about how to beef up oversight of research and pay for that increased vigilance at a time when federal agencies are overloaded and state governments are in financial crisis.
Kass says that one area where the commission has the potential to make real progress is in helping to shift the emphasis on oversight from simply meticulously documenting adherence to federal regulations to thinking more deeply about ethical issues.
"When there have been exposes of bad things, there has been more of a temptation to have IRBs create more refined and narrow paper trails, rather than necessarily doing deeper broad-based thinking about the risks and benefits of research," she says. "There have been growing concerns that IRBs are spending inordinate amounts of time on the wrong things.
"An examination of the Guatemala study could be an opportunity for the commission to say: The really important thing for IRBs to look at is whether people are being harmed, whether people are being exploited and whether people know what's going on."
Kass notes that the Guatemalan study is an example of a true ethical lapse. "It's not an example of an IRB not typing up their minutes, which has gotten some institutions into deep trouble. To me, the silver lining in this tragedy is that it reminds us what are the really important ethical problems in research that we have to worry about."