WAIVED-CONSENT TRIALS AND TRIBULATIONS
June 19, 2006
With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection.
Patients in these types of studies are treated under a broad federal rule that allows researchers to test emergency treatments on patients with specific, life-threatening medical conditions without their explicit consent as long as they remain under close watch of independent reviewers.
Federal officials and doctors agree that research is key since emergency treatments like AutoPulse -- a portable, battery-operated device used to revive cardiac arrest patients -- and PolyHeme -- a blood-substitute -- are largely untested, but critics say the trials are conducted on a slippery ethical slope, because, in most cases, patients never have the opportunity to give their consent, says Robert Davis of USA Today.
According the Journal of the American Medical Association (JAMA):
- Researchers tested AutoPulse head-to-head against manual chest compressions during CPR and found that 6 percent of patients treated with AutoPulse survived, compared to 10 percent of patients who received manual CPR.
- Of the 65 people who were treated in Seattle, seven were discharged from the hospital alive, while 17 of the 66 who received manual CPR were.
- In March 2006, the data-monitoring board stopped the trial, finding the device to be harmful to patients.
According to the American Journal of Bioethics:
- PolyHeme has raised concern among some ethicists and in Congress since the people who live in the 19 states where it is being tested have had inadequate notice about the trial.
- They also claim that the trial withholds available treatments, like blood transfusions.
- Amid the controversy, some cities stopped enrolling patients while preliminary data was reviewed, but all sites resumed the trial after the board concluded that patients were safe and that it was safe for the trial to finish.
Source: Robert Davis, "Traumas create unwitting test subjects," USA Today, June 14, 2006; based upon: Al Hallstrom et al., "Manual Chest Compression vs. Use of an Automated Chest Compression Device During Resuscitation Following Out-of-Hospital Cardiac Arrest," Journal of the American Medical Association, vol. 295, no. 22, June 14, 2006; Kenneth Kipnis et al., "An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme Trial," American Journal of Bioethics, vol. 6, no. 3, May-June 2006.
For JAMA abstract:
For Bioethics abstract:
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