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Saturday, June 16th 2007

Ethical Trauma Research?

This is ambitious, as WaPo describes it.

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 the 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.

About 40,000 such patients show up at hospitals each year, and the standard practice is to give them saline infusions to stabilize their blood pressure. For the study, emergency medical workers are randomly infusing some patients with “hypertonic” solutions containing much higher levels of sodium, with or without a drug called dextran. Animal research and small studies involving people have indicated that hypertonic solutions could save more lives and minimize brain damage.

You don’t give give your consent for standard of care procedures in these kind’ve trauma situations anyway. How far do trauma care practices have to be vetted for research like this to be run?

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 stories in local media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.

Trauma research like this has sparked interest before. We all remember some of these blood substitutes over the past several decades. Personally I think, just from this short story, these studies seem pretty within bounds.