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Ethicist Sees Decline in Human Research Protections

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Nov. 24, 1999 (Washington) -- While the protection of individuals involved in medical experiments should be paramount, the reality is that crucial safeguards are being undermined, often in the name of science. That's the view of a "Special Communication" published in the Nov. 25 issue of JAMA.

"Current trends in research and research regulation continue to erode the requirement of consent," writes Beverly Woodward, PhD, a medical ethicist at Brandeis University, in the article. As an example, Woodward notes with alarm a recent recommendation from the National Bioethics Advisory Commission (NBAC) to allow permission for individuals with "impaired decision-making capacity" to take part in research of greater than "minimal risk" that might not help the individual, as long as the trial benefits the population under study.

Woodward says a huge increase in available money combined with computers and a variety of new research tools to process information all contribute to the weakening of patient protections. "The tendency now to use patient records, patient specimens, imaging ? all these materials appear to be grist for the research mill," Woodward tells WebMD. She argues that researchers now routinely say the interests of science put the burden of proof on those who stand in the way of progress.

Woodward insists it's becoming easier to sell the argument to standard-setting institutional review boards (IRBs) that it's too difficult to get informed consent for a large-scale trial. That can lead to revelations about a patient's most guarded medical secrets. "If somebody wants to deal with DNA analysis on your blood sample, and an IRB agrees that it's minimal risk, they can go ahead and do it, but you might not think it's minimal risk," she says.

According to Woodward, the recent series that appeared in the New York Times documenting how physicians were secretly paid "bounties" to recruit patients into drug trials is an example of how the system can be turned on its head. "If everybody ? can be ? put under a microscope ? by this research process, it means everybody, in a way, becomes a research object," says Woodward. She also says patient deaths in gene therapy experiments bring into question whether those involved understood the risks.

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.

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