International Research:
Capacity, Compensation, and Community

In the last issue of MHR, Paul Ndebele discussed the problem of undue inducements in internationally sponsored research. This InkLinks continues that discussion.

InkLinks is a regular column in which readers reflect on issues related to the lead article. It is meant to tap the rich intellectual resources that this network provides. We welcome your contribution at leahtamar@comcast.net.

Rethinking Capacity Development for Ethical Review for Human Subjects Research in Developing Countries

Paul Ndebele's essay, "Undue Inducement in Internationally Sponsored Research," touches on four troubling problems in the ethics of research on human subjects outside the industrial countries: need for individuals to become or continue as subjects of health-related research; vulnerability of individuals to undue inducements to do so; what kinds of inducements would encourage but not coerce; and how to develop and improve local capacity for effective ethical review and monitoring of proposed and continuing human subjects research. Professor Ndebele, based in Zimbabwe and active in the politics of health and medical research ethics in sub-Saharan Africa, has keenly and rightly felt the need to strengthen local capacity to screen and review human subjects research for ethical problems, including undue inducement. He would channel any inducement money into local community benefits, in order to thwart coercion of individuals while appealing to communal values to attract and retain research subjects. His remarks prompt second thoughts about capacity development in this context.

He and others have assumed that capacity development is a proper quid pro quo for research on local populations and have proposed that sponsors and investigators therefore contribute out of program and project funds. One proposal would use possible community benefit to justify burdens to individual research subjects. These approaches seem unlikely to eliminate coercion where individual rights go unrecognized. Moreover, they perpetuate a misperception of probable benefit from most or all research on human beings, and they encourage dubious bargaining for access to research subjects.

Research sponsors (whether governmental or private) and researchers are not disinterested contributors to capacity development, even for ethics review, and local authorities that see health research on human beings as a financial boon or as a certain answer to health problems are on a wrong track. However, there is a long history of donor-country contribution, often successful, to educational, scientific, technological, and public health capacity in developing countries. Donor countries' international assistance agencies, not sponsor agencies or research programs, should be contributing to the infrastructure for ethical research but not as a quid pro quo. Such aid might take the form of exchange programs and consultation rather than direct subsidy and should have as a principal goal the general strengthening of host-country institutions for conscionable conduct of human subjects research.

"To those people in the huts and villages across the globe struggling to break the bonds of mass misery," President Kennedy said in his inaugural address, "we pledge our best efforts to help them help themselves, for whatever period is required—not because the Communists may be doing it, not because we seek their votes, but because it is right." That thought still holds.

Gerald S. Schatz
Assistant Professor
Center for Ethics and Humanities in the Life Sciences
College of Human Medicine
Michigan State University

Challenges in Implementing Community Compensation

As a researcher who works almost exclusively in less developed regions, I found Dr. Ndebele’s article an insightful commentary on the double-edged sword faced when trying to appropriately compensate study subjects in such environments. Too little compensation fails to recognize the value of the subjects’ scientific contribution in terms of time, effort, inconvenience, etc. Too much compensation and one risks inadvertently using fiscal coercion for recruitment—in regions where people may earn less than one dollar for hard labor (if they are lucky enough to be in paid employment!) this is amazingly easy to do.

Ndebele suggests that compensation to research subjects in developing regions should be commensurate with payment to their developed region peers. He also recommends that benefits be distributed across the research subjects’ communities as a way to obviate the risk of coercion. In other words, transferring the benefits from individual compensation to community compensation would encourage people to participate in research trials without unfairly inducing them.

While I whole-heartedly agree with Ndebele’s ideas, operationalizing such plans would not be trivial and, without a substantial investment at the start, developing appropriate mechanisms would be difficult to put into place. Also, the promise of community goods should not serve as a distracter. If the results or application of research fails to offer any benefit to the population under study then no level of community compensation would make the con-

duct of such research ethical in that population. Finally, the use of such funds to assist in “leveling the playing field”—to allow local researchers an equal capability for recruitment even when they lack significant funds for compensation—would not be addressed by such wealth redistribution (that is, shifting benefits from individuals to communities) and might simply shift the bias from patient-level decisionmaking to institutional or community level refusal. Mechanisms would need to be in place to encourage and support local researchers as well as important research on neglected conditions, such as African Sleeping sickness, which only impact populations in developing regions and therefore invite little commercial interest from the pharmaceutical industry.

Ndebele’s article offers excellent ideas on this complex issue. Further dialogue incorporating input from some of our international colleagues involved in human subjects protections would be extremely valuable.

Gretchen L. Birbeck, MD MPH
Director & Associate Professor
International Neurologic &
Psychiatric Epidemiology Program
Michigan State University