Ethics of neuroimaging research to be focus of NIH/Stanford meeting
STANFORD, Calif. - Learning about how the brain works often involves studying the brains of healthy volunteers. But what are researchers' obligations to the volunteers when those normal brains aren't so normal?
That's the focus of a Jan. 6-7 meeting in Bethesda, Md., sponsored by the National Institutes of Health in collaboration with the Stanford University School of Medicine, designed to help research institutions set standards for their brain imaging studies.
Judy Illes, PhD, senior research scholar at the Stanford Center for Biomedical Ethics, who is chairing the meeting, said she realized the scale of this issue in 2002. At that time, she, radiology professor Scott Atlas, MD, and others at Stanford published a study showing that 18 percent of normal volunteers had unusual features in their brains. About 6 percent of the people required follow-up by a doctor. These features could be harmless, such as a benign cyst, but could also be life-threatening malignant tumors or abnormalities in the blood vessels.
Such results pose thorny problems that researchers must now consider. If, for instance, the benign tumor is added to the volunteer's medical record, it could alter health insurance rates - a fact research subjects may not realize.
In other types of studies - including some on the horizon - the subjects may find out things they didn't want to learn about how their brain responds to certain images. Who, if anyone, should tell a person that his or her brain showed an unusual response to sexual or aggressive images?
Illes also pointed out that undergraduate students sometimes operate the machines that acquire the images for this sort of research. "When a subject goes into the study, does he or she know it might not be a medical professional who looks at the brain images?" she said. While one possibility is to make sure that all brain studies have medical professionals on the research team, the cost of having a doctor read every scan would be staggering.
"I would love to see a basic framework that all institutions could adopt," Illes said. The meeting will include researchers, lawyers, ethicists, clinicians and policy-makers who will discuss the best way for research groups and institutions to handle abnormalities found in healthy volunteers. The issue is so timely that eight of the NIH institutes and two institute directors will be represented at the meeting.
Illes said right now research groups handle these abnormalities, which they call incidental findings, in different ways. Some try to address all cases while others hold the view that when people volunteer for a research study they shouldn't expect additional medical care.
Illes said she tried to include the full range of opinions in putting together the meeting. "The idea is to come up with solutions to protect our research volunteers, patients as well as our institutions," she said. She hopes the ideas coming out of this meeting will establish uniform ethical approaches of dealing with incidental findings. "I think this meeting has the potential to change how brain imaging studies are done," she said.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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