I Was in a Scientific Study? No One Told Me
By Eric Sabo, Medical Writer, CBS Healthwatch
In fact, withholding relevant information from study volunteers is a major source of trouble. Documents from the National Institutes of Health show that informed-consent problems accounted for 34% of government crackdowns on clinical trials over the past 10 years, making this the second leading reason why researchers were cited for violations. A similar pattern of bad advice is also alleged in several recent lawsuits.
"Patients think they're talking to a doctor, but they're really talking to an entrepreneur," says Alan Milstein, an attorney who represented Jesse Gelsinger's family and is now suing the University of Oklahoma for misleading subjects on the true nature of a cancer vaccine trial. "What we find in these cases is that even though the risks may be in the consent form, the doctor will say, 'Don't worry about it. This is just something our lawyers make us put in.'"
Such serious breeches of trust, many experts contend, are far more the exception than the rule. But some worry that these high-profile abuses may scare off patients and undermine legitimate efforts to find new treatments. US research has emerged from the Cold War days of secretly feeding radioactive oatmeal to a group of mentally handicapped children--one of several horror stories that came out of a 1995 investigation by the Department of Energy. Still, the current atmosphere of little white lies and questionable financial arrangements points to a deepening crisis.
Some key concerns:
- Drug companies are demanding faster recruitment, larger trials, and more and more subjects with very specific types of problems. Out of all the research protections in place, informed consent may take the biggest hit from these pressures, concludes a recent US inspector general's report.
- Clinical trials are rapidly shifting from public medical centers to private research facilities, where there are no legal requirements that determine what patients should be told about a study. Nearly half of all research is done in private settings, up from 20% just 5 years ago.
- Doctors have increasingly lucrative deals to recruit subjects and conduct studies. Yet a recent survey of review boards that oversee this research found that only 25% looked at whether these dealings might pose a conflict of interest.
- A record number of children are entering clinical trials, and parents may not understand all the complicated problems that may be involved in volunteering their kids for research. A new report in the Lancet, for instance, found that 22% of mothers did not fully realize the discomfort their infant might go through in a study.