Sharing benefits in international health research

Over the past decade, clinical investigators and sponsors have shown increased interest in conducting clinical trials and other health‐related research in resource‐poor settings, notably Asia, Africa and South America. This move to poorer countries can bring many benefits: personnel costs are lower, and it is easier to recruit participants and to implement placebo‐controlled trials that produce less ambiguous data, which might reduce the time it takes to approve a new drug. For the people in these areas, participating in clinical trials or basic research is often beneficial because it can give them an otherwise rare opportunity to access medical care (Ballantyne, 2005). However, such research does not always address local health needs. Research participants are sometimes provided with medical care that is below the standards of developed countries, and drugs or therapies are not always made available to participants and their communities once they have been authorized for sale in North America or Europe. Although such research usually involves some benefits for participants and their communities, these benefits can still be unfair when compared with the benefits that sponsors and future patients in wealthier countries gain, or when the benefits do not outweigh the risks assumed by the participants and involved communities. In such cases, the research is exploitative. It has been claimed that, in order to reduce exploitation in international health research, sponsors should provide ‘fair’ benefits to participants and their communities (Participants, 2002, 2004). Although there has been much debate about what constitutes ‘fair’ research benefits, the related practical questions have received less attention. What is the range of possible benefits? Can they be distinguished in ethical terms? What concrete measures can be used to implement them in an ethically defensible way? In this article, we discuss advantages and challenges in the implementation of what we …