NIH Clinical Center

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CC staff articles gain national notice

Several Clinical Center researchers gained national notice last month by publishing thought-provoking papers in two respected medical journals, the "New England Journal of Medicine" (NEJM) and the "Journal of the American Medical Association" (JAMA).

The July 7 JAMA article was written by Diagnostic Radiology Department staffers Dr. Gregory Katzman, Dr. Azar Dagher, and Dr. Nicholas Patronas. The paper, "Incidental Findings on Brain MRI from 1000 Asymptomatic Volunteers," detailed how the researchers studied brain MRI scans from 1000 volunteers who participated in various NIH studies as control subjects between May 1996 and July 1997. All volunteers were deemed healthy and asymptomatic after a medical history and physical examination. While 82 percent of the MRI brain scans were indeed normal, the researchers found that 18 percent (180 scans) showed abnormal results.

Of these, 29 patients were referred for further medical evaluation, and 3 were found to have brain tumors.

"The CC Diagnostic Radiology Department does the imaging for most NIH protocols, including the normal volunteers," said Dr. Dagher. "We saw a unique opportunity to pool a great number of normal-volunteer brain MRI's to study the rate of incidental findings in a normal population."

The Clinical Center's archive of these and other types of scans represents a vast resource for more look-back studies.

"It's conceivable that we could go back through 12 years and maybe get 10,000 normal-volunteer scans," said Dr. Dagher. "That's something no university can claim, unless it pooled resources with several other institutions."

Similar studies had been done elsewhere, but on scans performed on people referred for a clinical concern or symptom. This could increase the likelihood of finding a disease.

"We put less weight on the reported rates in this study, but rather emphasize that the population studied was as close to truly normal as possible, so the findings likely represent true incidental abnormalities," Dr. Dagher explained. "We hope our study will serve as a significant reference for researchers who quote incidences or prevalences of various disease syndromes in normal groups."

The July 15 NEJM editorial, "What's the Price of a Research Subject? Approaches to Payment for Research Participation," is by Neal Dickert and Dr. Christine Grady of the CC Department of Clinical Bioethics.

"Clinical investigators at the CC and elsewhere are struggling with the issue of how and under what circumstances to pay subjects," said Dr. Grady. And some wonder whether research volunteers should be paid at all.

"At the Clinical Center, and elsewhere, healthy volunteers are usually paid. Patient volunteers are increasingly being paid, but not all of them, or always," said Dr. Grady.

The NEJM editorial outlines three possible methods for paying research participants: a market model, a wage-payment model, and a reimbursement model. The authors advocate the wage-payment model as the most ethical of the three. The wage-payment model operates on the belief that participation in research requires little skill, but does require time, effort, and the tolerance of undesirable or uncomfortable procedures. Research subjects should therefore be compensated for their time and effort. The wage referred to could be the minimum wage or another dollar figure.

"It's a matter of thinking about the activity as a type of 'unskilled labor' and deciding on a per-hour compensation that makes sense for that," said Dr. Grady.

The reimbursement model provides payment simply to cover subjects' expenses, such as travel, and meals. According to the authors, this model precludes profit and actually requires financial sacrifice for most participants.

The market model assumes that money is the major incentive for research participation, and therefore subjects would be attracted by large payments and bonuses for study completion.

"Letting the market determine payment is ethically problematic," said Dr. Grady. "It encourages paying more for increased risk, and could drive out important but less well-funded studies."

Despite the controversial nature of the topic, the authors published their opinion for others to consider.

"Payment is already a part of what's going on," Dr. Grady said. "We asked, How can we approach it in a way that's more standardized and ethically acceptable than some of the current practices?"

The editorial notes that the opinions expressed are those of the authors and do not necessarily reflect those of NIH or the Clinical Center.

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