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Ethicist Sees Decline in Human Research Protections

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While all that is a far cry from Nazi war crimes or the Tuskegee experiment, in which black men believed they were getting syphilis treatment but weren't, Woodward says research on individuals without complete consent erodes their freedom and concentrates power in the hands of those who control medical information. Managed care research into quality measures and medical outcomes also tends to centralize information that may be used in destructive ways, says Woodward.

"Right now, there's a tendency to want to waive consent or override the consent requirement," says Woodward. While there's no quick fix, she says that much more attention needs to be focused on IRBs, which are often overwhelmed by their complex task, allowing them to spend as little as one or two minutes evaluating a study.

In general, Woodward says that national oversight is lacking. "We need to get a comprehensive view of what's going on. We need a comprehensive view of all the adverse events. We don't have that at all," she says. She points out in her article that the federal Office for Protection from Research Risks (OPRR) suspended research activities at eight institutions in the last year, at least in part for failing to provide proper patient consent.

Meanwhile, NBAC itself is in the midst of reviewing safeguards for those involved in medical research. In an earlier report quoted by Woodward, the agency said "the U.S. government cannot know how many Americans currently are subjects in experiments ? cannot ensure that research subjects know and understand the risks they are undertaking, and cannot ascertain whether they have been harmed."

In an accompanying JAMA editorial, Gary Ellis, PhD, of OPRR, says Woodward's conclusion that patient protections are eroding is "too strong." However, he says that scientific research can only be done in keeping with the highest ethical standards, and that institutions that don't educate themselves about research ethics are "courting trouble."

Not only is the IRB mechanism flawed, says Lawrence Gosten, JD, co-director of the Georgetown/Johns Hopkins Program on Law and Public Policy, but many kinds of research in the private sector don't go through any formal review mechanism. "The system of legal safeguards is way behind the current push for more research, and we need to upgrade the safeguards," Gosten tells WebMD.

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