Call a Doctor
B. J. Casey, a psychologist at Weill Medical College of Cornell University who took part in the NIH meeting, recounted the first time that her team stared at an odd white mass on the MRI scan of a normal volunteer. "We all realized it was something that shouldn't be there," Casey says. "But we aren't doctors, we aren't neuroradiologists, we're researchers."
Casey did call in a neuroradiologist, who concluded that the mass was a brain tumor. "We saved this person's life," she states. Nevertheless, the situation and others like it are uncomfortable. "We don't want to enter into a patient-doctor interaction in a research study," Casey says. "We have to separate research from clinical practice." Then, she adds, the problem becomes, "How do you even know something is important enough to tell a person? Anything abnormal should be confirmed" first. Casey now runs pediatric scanning studies and shudders at the thought of "telling parents something is wrong with their child when it isn't."
Who tells a parent or an adult subject about an incidental finding is an issue, too. Scientists could simply say nothing; there is no requirement in a study scenario. Others might call in a doctor, and if the physician agrees something is suspicious he or she could refer the volunteer to a specialist. Alternatively, a researcher could advise a subject to contact his or her own doctor for follow-up. Or the scientist could call the doctor directly and have him or her address the patient.
Most studies do not include a physician, and participants at the meeting disagreed over whether they should factor a doctor into the cost of a study. "Researchers may be able to detect obvious abnormalities, but they don't have the basic knowledge to make diagnoses," says Ruth Macklin, a professor of bioethics at the Albert Einstein College of Medicine. Therefore, she maintains, the cost of a doctor or radiologist should be included.
Another vexing issue is that scans used for research are typically not as sophisticated as those in a clinical setting. As a result, the images might be harder to read and interpret by untrained eyes. Buying more expensive machines would further drive up study costs.
By meeting's end the group at least agreed that the consent forms volunteers sign should lay out the possibility that a normal brain might not always look "normal." The form could ask patients whether they want to know about what seem to be minor findings. And the document should specify that markers of potentially major abnormalities, such as a blood clot, aneurysm or tumor, would trigger immediate attention, whatever that might be. The group agreed to begin drafting guidelines for IFs, including the recommendation to inform subjects and when to refer them to a physician.
Given my own experience, I'm heartened that scientists are paying more attention to this problem. After all, I represent the normal volunteer who was abnormal. I'm glad to know that my dopamine levels are so high that I will probably never get Parkinson's disease. And I've got a picture of my brain, the cyst hogging a good chunk of my cerebellum--the area that controls movement. If I do have any complications from that, it's nothing more than a sore toe on my dancing partner's foot.
This article was originally published with the title The Ethics of Scan and Tell.