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"Critical Care Without Consent"

This article in today's Washington Post (5-27-2007), both surprised & shocked me. I'd dearly love to hear what med-mal paralegals think about these research studies:

"The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting patients' permission.

"The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.

"The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries. Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say.

"The project has been endorsed by many trauma experts and some bioethicists. Others question it. The harshest critics say the research violates fundamental ethical principles.

[snip]

"'We will never know the best way to treat people unless we do this research. And the only way we can do this research, since the person is unconscious, is without consent,' said Myron L. Weisfeldt of the Johns Hopkins University School of Medicine, who is overseeing the project. 'Even if there are family members present, they know their loved one is dying. The ambulance is there. The sirens are going off. You can't possibly imagine gaining a meaningful informed consent from someone under those circumstances.'

"Before starting the research at each site, researchers complete a 'community consultation' process. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements, and through reports in local news media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate."

The reader comments about this news are worth a look. Personally I'm in favor of getting one of those "refuse to participate" bracelets!

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