Health research: The challenges related to ethical review and informed consent in developing countries

The globalization of clinical trials, as well as the creation of funding mechanisms for research addressing the health problems of developing countries, have led to a significant increase in the number of research projects in the South. This paper reports on a workshop held by the Switching the Pole Network in Antwerp in December 2008 to assess the challenges of ethical review and of the informed consent process in vulnerable populations. A systematic approach to ethical review is needed, promoting trust among research partners and improving the efficiency of international ethical review practices, while building communication strategies across traditional geographical boundaries and power structures. At the moment, the double ethical review of research sponsored or funded by Northern organizations in resource-poor settings can minimize the risk of double standard practices and enhance the protection of study participants and populations. We also need guidance to prevent the exploitation of vulnerable populations in health research; in particular those whose participation is not based on a free choice but on the necessity to access otherwise inaccessible medical care or other benefits. We hope that the issues raised can feed a debate leading to better guiding principles on health research in resource constrained settings.