NIH/Stanford meeting discusses ethical standards for neuroimaging research
Judy Illes
BY AMY ADAMS
Learning about how the brain works often involves studying brains of healthy volunteers. But what are researchers’ obligations to volunteers when those normal brains aren’t so normal?
That was the focus of a Jan. 6-7 meeting in Bethesda, Md., sponsored by the National Institutes of Health in collaboration with the Stanford 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 chaired 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.
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.
The event co-chair, Emmeline Edwards, PhD, acting deputy director for extramural research at the National Institute of Neurological Disorders and Stroke, said the meeting helped bring together people with different ideas about how to handle incidental findings. “We had some very lively discussions, “ she said.
Illes called it a “phenonmenal success.”
And Illes added, “I think these conversations will translate into a basic framework that all institutions could adopt.”
The meeting included a wide range of researchers, lawyers, ethicists, clinicians and policy makers who debated 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 were represented at the meeting.
Illes hopes the ideas that came out of the 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.
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