St. Paul Study Would Waive Patient Consent

Aug. 4–When a study involving experimental CPR devices starts as early as next month in St. Paul, it will be one of only a dozen to gain federal approval to be conducted without patient consent.

It also symbolizes changing attitudes and procedures when it comes to medical ethics and informed consent.

Twelve years ago, the U.S. Food and Drug Administration stopped St. Paul paramedics from testing CPR devices on cardiac-arrest patients, even though the experimental devices appeared to save lives. The predicament led federal officials in 1996 to create the first regulations allowing research without the informed consent of patients in emergency situations.

Now, the St. Paul study is back and public hearings about it take place today. This time, with federal approval, paramedics in St. Paul and Minneapolis will test two experimental suction devices that are already being used in Europe to improve survival of cardiac arrest by dramatically increasing blood flow.

Informed consent remains a staple of medical research — a protection born out of infamous cases such as the Tuskegee research in which scientists monitored poor black men in Alabama without telling them they had syphilis or treating their disease.

People still expect protection from this type of exploitation, said Jeffrey Kahn, director of the Center for Bioethics at the University of Minnesota. But many are equally interested in removing barriers to experimental treatments they might need.

As a result, leaders of the CPR study expect less concern about consent waivers and more concern that some patients near death will only receive standard CPR and not the experimental treatment.

That concern became more prevalent early in the AIDS crisis when the only treatments available were experimental, Kahn said. It also created an environment in which patient-consent rules could be relaxed.

The key in research is making sure that patient consent is only waived when necessary, said Kahn, who served on a presidential commission investigating plutonium injections given during the Cold War without patient consent.

“The whole enterprise of research on humans hinges on public trust,” he said. “If we don’t go about this right, we stand the risk of undermining that public trust.”

Consent waivers are only given in emergency circumstances, when researchers can demonstrate that their research has lifesaving potential and can’t be done any other way. The research isn’t supposed to present greater risk to patients.

These and other restrictions explain why the FDA has only approved 11 other consent waivers for research involving medical devices and several more for research of new drugs or biologic products.

Consent waivers have been controversial. One of the first was granted for a study of synthetic blood for critically ill patients. It was halted in 1999 when researchers discovered a higher-than-expected death rate among patients who received the blood alternative.

A consent waiver has since been granted for a similar study of a blood alternative called Polyheme, which is believed to be safer. The research, taking place at the Mayo Clinic and elsewhere nationwide, is ongoing.

As with the upcoming St. Paul study, numerous public meetings and notices in the media preceded the Mayo study. Dr. Andy Boggust said he hoped those efforts at least assured the public of the research, but he didn’t pretend that they substituted for informed consent.

“You’re doing research on people without their consent. Period,” said Boggust, of Mayo’s department of emergency medicine.

He didn’t see an alternative, though. It would be a cruel form of “coercion,” he said, to ask patients in trauma situations whether they are interested in a study that could improve their odds of survival.

The new study, which likely will start in September, will involve people in St. Paul and Minneapolis suffering cardiac arrest, which is when the heart suddenly stops beating as the result of a heart attack, stroke, drowning or other cause. It is not the first no-consent study in the Twin Cities.

The Hennepin County Medical Center, for example, participated in a national study on the effectiveness of placing defibrillators in public places. The research needed a waiver because the people trained to use the devices didn’t have time to gain consent from people in cardiac arrest.

The death rate decreased slightly because of the availability of defibrillators, said Dr. Brian Mahoney, medical director for emergency medical services at the Hennepin medical center.

Mahoney is involved with the upcoming CPR study as well, which examines two devices made by Advanced Circulatory Systems Inc. of Eden Prairie. One is placed on top of the chest and acts like a plunger. The other is placed atop a CPR mask and regulates airflow.

The devices can work separately, or together, to create a vacuum in the chest that increases blood flow much better than traditional CPR. The lack of blood flow is a major reason the survival rate from cardiac arrest in the Twin Cities is just 10 percent.

“Survival after cardiac arrest is poor,” Mahoney said. “In order to change that, you need to study good ideas about how to improve that” survival rate.

Jeremy Olson can be reached at jolson@pioneerpress.com or at 651-228-5583.

“The whole enterprise of research on humans hinges on public trust. If we don’t go about this right, we stand the risk of undermining that public trust.”

Jeffrey Kahn, director, University of Minnesota Center for Bioethics

What is the study trying to prove?

Two devices, made by Advanced Circulatory Systems of Eden Prairie, are already used in Europe to augment CPR for patients suffering cardiac arrest, which is when the heart stops beating. Researchers are studying whether the devices improve survival rates — proof that federal officials require before approving the devices for use in the U.S.

Why is patient consent being waived for this study?

Paramedics would be unable to gain consent initially from patients who are unconscious. Patients or relatives would later be asked to continue in the study, which would monitor the health and functioning of patients after their cardiac arrests.

Who is eligible for the study?

Cardiac arrest victims 18 or older in St. Paul, Minneapolis, Falcon Heights and the State Fairgrounds will be eligible for the study, which is tentatively scheduled to start in September. People possessing “do not resuscitate” orders and those involved in violent trauma will be excluded.

What are the risks?

The risks are supposed to be no greater than those with standard CPR. One risk of any CPR is broken ribs, but physicians believe that is an acceptable risk given the likelihood of death without resuscitation. An independent board will monitor the three-year study and stop it early if initial results show higher death rates or other problems.

How will rescuers decide what type of CPR to provide?

Patients will randomly receive one of three types of CPR: traditional, with the mouthpiece device alone, or with the mouthpiece and chest devices.

Do patients have any legal recourse if something goes wrong?

Even willing participants have sued when experimental treatments cause bad outcomes. Health law experts said many cases are settled, but researchers who follow required safety and research guidelines are generally protected.

IF YOU GO: Public forums must be held in order to gain approval from the FDA for paramedics to use experimental CPR devices on cardiac arrest patients without consent.

The St. Paul forums will be held at 9 a.m. and 6 p.m. today at the Kelly Inn in St. Paul.

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