In its 2002 report ("The Ethics of Research Related to Healthcare in Developing Countries"), the Nuffield Council concluded that externally funded research in developing countries is crucial but must be subject to rigorous ethical safeguards to prevent the exploitation of those who take part. Rather than setting out guidelines, the report provided an ethical framework for those designing or conducting externally sponsored research in the developing world.
In 2005, a follow-up paper ("The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper") went further. Four very sensitive topics were identified:
- Standards of care
- What happens after the research is over
- Ethical review
- Adequate review of ethical and scientific aspects of research proposals
- Collaboration between different institutional review boards (IRBs), particularly committees in host and sponsor countries
- Capacity building
Such capacity building has the potential to meet the needs of research processes, trial participants and local communities. Researchers and sponsors should aim to strengthen local capacity and to implement research in a manner that leaves behind sustainable improvements in service provision. Development of local expertise in research is actually so important that it must be an integral component of research proposals.
The difficult mission of IRBs in developing countries
Established In 1974 by the U.S. Congress as a committee designated by an institution to review and approve the initiation of biomedical research involving human subjects, the (IRB) model has been exported to developing countries.
But IRBs abroad are facing many challenges:
- The institutional review process is in a very concrete way beset by a number of problems, ranging from recruitment of qualified members, logistical delays to more substantive differences of opinion that cannot easily be resolved.
- Guidelines are numerous, originating from local, national and international authorities. Ethical uniformity is practically impossible.
- The boards' responsibility cannot be limited to implementing guidelines imported from the outside. Such an approach fails to recognize the specifics of deciding in a complex setting of many competing disciplines, people and regulations. Identical ethical principles can lead to different conclusions in concrete cases. In the work of IRBs, you really have to deal with complexity management.