The international picture

Different countries have different standards for paying clinical trial participants. In some places, says National institutes of Health's Christine Grady, a bag of rice or a bag of soap are considered more appropriate than cash. Institutional Review Boards (IRB s) say they try to translate US standards for payment into amounts appropriate for the region. The Human Subjects Committee at Harvard's School of Public Health, for example, sees mostly international studies on HIV, tuberculosis and malaria. "In so many of these countries there just isn't a regulatory structure yet," says Michelle Mello, a professor of health policy and law who co-chairs the committee. "But typically we would ask investigators to tell us what is an average wage in this part of the world, and if they were uncertain we would hire an independent analyst to look it up." One exception is South Africa. David Borasky, director of the Office of International Research Ethics at Family Health International, pays subjects in trials there approximately $22 USD per visit. South African collaborators have told him it's the unofficial payment policy for all trials.

Sometimes the complexities go beyond rules or customs. Kevin Irwin says his research group, led by Robert Heimer of Yale University, partners with nongovernmental organizations (NGO s) in India and Russia to study HIV prevention. While the investigators on principle have long paid US subjects in cash, they can't insist on that when an NGO has been recruiting subjects without cash and doesn't have the resources to compensate. "As a sociologist, I understand that all people live in communities, and introducing research into research-naïve communities comes with a lot of responsibility," says Irwin

The issues are growing in importance as many of the 50,000 industry-sponsored trials in the United States increasingly move abroad, says Ken Getz of the Tufts Center for the Study of Drug Development. Today, the center estimates, nearly half of all US industry-run clinical trials are conducted by investigators in countries such as eastern and central Europe, Latin America, China and India. A recent review by the Association of Clinical Research Professionals reported that in Russia, the number of patients enrolled in international clinical trials jumped from about 16,000 in 2002 to about 37,000 in 2005. From discussions between sponsors and US IRB s to negotiations with the investigators abroad, "you can imagine the logistical challenge" of figuring out how much to pay subjects," says Getz.