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Outsourcing Medical Studies--and Ethical Quandaries--to Africa

African countries that are home to much of the world's human medical research have created institutions to deal with ethical issues, but these committees face significant hurdles--like never meeting in person
african boy wincing at needle



© ROBERT PATRICK/CORBIS SYGMA
If a researcher at a major U.S. university wants to do a clinical study of a new vaccine, he or she first must obtain the approval of an institutional review board. More often than not, the panel comprises the researcher's colleagues and peers who are either personally acquainted with the researcher or, at least, know of the researcher's work as well as the recognition—and funding—that it could attract. In other words, the people in charge of green-lighting or nixing the study have a stake in the outcome. Getting a handle on such ethical matters is difficult enough here, let alone in a developing African country, where a grant can mean far more to a given institution.

But some African nations are trying to change that: According to a recent survey of members receiving international training, at least nine African countries—Democratic Republic of the Congo, Ghana, Kenya, Nigeria, South Africa, Sudan, Tanzania, Zambia and Zimbabwe—have set up research ethics committees. "We find the emergence and some level of functioning of [research ethics committees] in the African continent. People seem to assume there's nothing there but that's not true," says international health researcher Adnan Hyder of Johns Hopkins University, a co-author of the study. "On the flip side, they are crying out for capacity development."

The panels surveyed varied widely. For example, South Africa has had such committees for 30 years; on the other hand, Congo and Kenya only established theirs in the past few years. Some boards review as few as eight protocols a year whereas others tackle as many as 600, and members ranged from a cadre of physicians and scientists to a more broadly inclusive group. Funding remains the primary obstacle—about half of the committees surveyed were subsidized by the government or foreign agencies and the other half relied on fees—ranging from $5 for a student-led study to $585 for one from industry.

But the trickier terrain of medical ethics—informed consent, appropriate review and other issues—remains more of a challenge, particularly when money is involved. "[One member] believed community members were loathe to reject protocols because studies bring employment," the authors write in a paper, published online January 22 in PLoS Medicine. "Another said protocols bring income to the institution and sometimes questions were not raised so projects could clear quickly."

This type of problem is not foreign to any review committee, but it is exacerbated by a lack of institutional support in Africa. One committee never physically met; another lacked "stationery, space, computers or communication facilities," the researchers note. "To have such a committee that doesn't meet in person leaves a lot to be desired," Hyder says. "It's quite clear that they are not close to what they could be in terms of their potential."

Committees that prove too inquisitive may also face the risk of projects being taken to other, perhaps more lenient countries. "That is a real possibility and we hope, therefore, that there is a continental shift in the right direction so there will be fewer windows left open for bulldozing research," Hyder says. "Africa as a continent has to address that." Already strong institutions exist in some places—for example, Makerere University in Kampala, Uganda—that can perhaps share their institutional knowledge and shore up their African colleagues. "You can't have a society where no other system works and expect the ethics committee to work perfectly," Hyder adds. "South Africa, Uganda and, increasingly, Nigeria have models that can help other countries." Until such strong ethics committees become ubiquitous, it remains ethically challenging to conduct medical research in many parts of Africa.

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