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Some studies bypass consent

Trauma victims may be part of a clinical trial without knowing it
by: L.E. BASKOW, Jerris Hedges, an OHSU emergency room doctor, hangs a bag of normal saline solution next to a new hypertonic test solution (left). The test solution has a greater salt content.

Starting next week, virtually every severe trauma victim in Multnomah, Clackamas, Washington and Clark counties will take part in an Oregon Health and Science University clinical trial.

If you're suffering severe shock or a brain injury, the paramedics will give you either a conventional intravenous saline solution or one of two experimental hypertonic solutions on the way to the hospital. You won't know which. The paramedics won't know which. And more important, you will not have consented to participate in the clinical trial.

From Jerris Hedges' point of view, this less-than-perfect scenario could not have been avoided. Hedges, an OHSU professor of emergency medicine, is principal investigator for the trial. He thinks the hypertonic solution just might save some lives.

But in medicine, thinking is different from knowing. Knowing requires a scientific trial. And a scientific trial, normally, requires informed consent - subjects fully informed and agreeing to participate.

But communitywide clinical trials lacking informed consent have begun, and more are on the way.

Hedges and researchers in 10 other participating cities around the U.S. and Canada who are testing the hypertonic solution face a dilemma: Unconscious people can't consent. And their relatives, even if nearby, can't be fully informed as proxies when every minute is critical.

According to Hedges, approximately three out of 10 people suffering severe trauma never recover - they die at the scene of the accident, in the ambulance or later in the hospital. There's no time to talk about side effects and previous research.

Mars Greenwood, a Portland hairdresser, objects. Greenwood, who had a previous run-in with OHSU when she visited the campus to ask for information about laboratory testing done on animals, is among those who don't like the idea of being part of a clinical trial without giving consent.

'It seems to me something like this, they're making a decision for the public,' Greenwood said. 'But I don't know anyone from the public that knows about it. I think they're overstepping their authority.'

Local approval was required

The OHSU study is being conducted under the auspices of federal Food and Drug Administration guidelines for exceptions to informed consent. It's the second communitywide exception study in the Portland area. The first, in 2003, compared automated defibrillators with standard cardiopulmonary resuscitation at different sites in the metro area.

Greenwood's social circles may not be representative - some Portland residents have learned of the saline study through various media outlets. But Greenwood's point, that most members of the public probably don't know about the trial, is valid.

And that, said Gary Oxman, health officer for Multnomah County, is something that might be handled better the next time an exception-to-informed-consent study is proposed.

Oxman is the primary reviewer of the hypertonic saline study for the federally mandated Multnomah County Public Health Institutional Review Board (IRB), which had to give consent for the study to proceed.

The researchers held four public meetings in the Portland area over the past few months to fulfill federal community consultation requirements. But Oxman admits they weren't well-attended. 'There were very small numbers,' he said. How many people attended? 'A few to a handful,' Oxman said.

Which means, he said, that researchers received very little feedback as to whether the majority of residents were willing to participate in the study. Random telephone calls were made, Oxman said, and between two-thirds and three-fourths of respondents said they'd be willing to participate in the study.

But far from a fourth of local residents have called OHSU to obtain special 'No Study' bracelets. The bracelets are the only way people can avoid being part of the study, and they need to be worn by accident victims when the ambulance calls. According to OHSU, researchers have received about 100 calls from people who wanted the bracelets.

A letter could have been mailed about the trial to all area residents. But Oxman said it's unlikely such a letter would have served its purpose. 'It would be very expensive, and I think there's a question of how much do people respond in the abstract to this kind of thing,' Oxman said.

Unconscious consent is tricky

Mary Ann Baily, a bioethicist with the New York-based Hastings Center, a national bioethics center, said that Greenwood and Hedges both have good points. There are fundamentally two ways of looking at a study without informed consent, Baily said.

'A hard-core research ethicist would say it's human dignity,' Baily said. 'It's not about whether most people would consent. It's about that they didn't consent.'

On the other hand, Baily said, changes are made all the time in the ways patients are treated, and most of the time the public isn't made aware. It's just when researchers want data to know for certain if a new therapy is an improvement that informed consent becomes an issue.

'They don't ask you which suture material you want them to use when they do an operation on you,' Baily said. 'When they start actually collecting data on whether it's better or not, suddenly the IRB gets involved.' Requiring consent in hard-to-consent cases, Baily said, could discourage researchers from doing the studies that prove which therapy or drug works better.

'Had there been significant danger in the study I think you would have seen our IRB be much more cautious,' Oxman said.

No all studies make grade

The review board also might have been more cautious, Oxman said, if the trial were being paid for by a drug company, not the National Institutes of Health.

In fact, just such a study was proposed a little over a year ago. A pharmaceutical company, Northfield Laboratories, wanted to test whether its artificial blood substitute, called PolyHeme, would work better than the standard saline solution in keeping alive trauma victims who were bleeding uncontrollably.

That national trial is nearing completion, but it never got off the ground in the Portland area.

According to Oxman, the Multnomah County review board was asked to approve the PolyHeme study, but the process of community consultation took so long researchers at OHSU and Legacy Emanuel became discouraged and withdrew their request.

PolyHeme has been studied at 32 participating hospitals around the country, but not without a fair share of controversy. Some patients, Oxman said, may have suffered side effects, possibly heart attacks, as a result of the PolyHeme therapy.

As far as Greenwood is concerned, what the researchers don't know going into clinical trials argues for informed consent.

'I think the public is blinded by our medical research,' she said. 'I'm taking their word for it that this is going to help people, but I'm not convinced.'

OHSU researchers already have approached the county review board for its next two communitywide studies that would forgo informed consent. The OHSU researchers want to study a plastic device that could help the body circulate more blood while paramedics deliver CPR on people whose hearts have stopped beating.

The consortium also is asking permission for a study comparing the ideal duration for paramedics to deliver CPR.

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How to get a "no study" bracelet

The bracelets are free from OHSU and must be worn when an ambulance comes if you don't want to participate in the study.

To obtain a bracelet, call 503-494-7015.