Many people seek to "opt out" of no-consent medical studies

Local researchers testing experimental treatment on unconscious or gravely injured patients without their consent say they are overwhelmed by requests for "No Research Study" bracelets by people who do not wish to participate.

A story in Sunday's Seattle Times outlined ethical concerns about two local studies that are part of a national test of experimental pre-hospital treatments on about 21,000 patients.

University of Washington researchers said they have not given out any bracelets so far. Although a study of the use of concentrated saline solution to stabilize blood pressure in trauma patients began last summer, administrators said they don't actually have any bracelets yet. They are on order.

Organizers of another planned study, which will begin looking next month at variations in timing of CPR and a use of a breathing-tube device for cardiac-arrest victims, also have ordered bracelets.

Dr. Peter Kudenchuk, principal investigator for the local studies, said, "We're presently overwhelmed by the requests for bracelets."

The response isn't unique.

For more information or to opt out of the studies:

Cardiac-arrest study: www.uwheartroc.org or 800-607-2926;

local 206-447-5671.

Trauma/saline study: www.roctrauma.org or 800-607-1879.

In Portland, researchers have given out more than 700 similar bracelets since research began there on a similar study of concentrated saline solution in trauma patients.

Denise Griffiths, research coordinator for the study at Oregon Health & Science University, said researchers there spoke to church groups, clubs, neighborhood associations and unions, and put fliers in grocery stores, bus stations and elevators.

FDA guidelines say researchers involved in studies where consent rules are waived must inform the community, disclose risks and set up a procedure for people to opt out.

Local study administrators said they had complied with those requirements by contacting local media, advertising on online lists such as Craigslist, sending out information in club newsletters and taking out ads in buses.

They've also commissioned surveys of several hundred King County residents to ask if they would want experimental treatment. About three-quarters said yes, but many added they would like to know more about the treatments.

Some readers said the research caught them by surprise.

Sharon Chastain, of Maple Valley, in an e-mail, complained that "over-eager researchers" had not adequately informed an "unsuspecting populace."

"It's ridiculous that I have to jump through hoops to stay out of an ill-conceived lab experiment," she said. " 'Several hundred' people were called? Craigslist? That doesn't touch even a tiny fraction of the county population."

Jade Grace, of Vashon, wrote that such studies should be "opt in ... like drivers' licenses designating organ donors."

Several medical providers who read the story commented that emergency care was unlikely to improve without such studies and said there is good reason to think the experimental treatments will be at least equal to, if not better than, existing treatments.

Jim Arrowsmith, a Seattle man who suffered a cardiac arrest while jogging in 2004, said he was saved by experimental hypothermia treatment, given without his consent, that was being tested in a small study.

"Needless to say, I'm quite glad they were able to go ahead with the experimental injection," Arrowsmith said.

Carol M. Ostrom: 206-464-2249 or costrom@seattletimes.com