Introduction

There are many ethical and social issues raised by developed countries undertaking or sponsoring clinical research in developing countries. These include:

• the extent to which individuals in developing countries should be invited to take part in research which may expose them, and the populations from which they are drawn, to a possible risk of harm, yet offer them little or no direct benefit;

• the responsibilities of investigators to research participants and the wider population after research has shown that an intervention is successful;

• the applicability and relevance of existing guidelines;

• the appropriate standard of care for control and intervention groups in research;

• the appropriate provision of information, and the capacity for voluntary consent;

• effective review, and ongoing monitoring, by research ethics committees;

• the ability of developing countries to set their own research agendas.

Many people in developing countries suffer from poor health and reduced life expectancy. Poverty, coupled with limited scientific, administrative and political development often makes it very difficult for developing countries to improve healthcare. Those who seek to improve the health status of developing countries do so against this background, in which poor health is a reflection of the larger

inequality in resources between developed and developing countries. Developing countries urgently need research related to healthcare that addresses their burden of disease. It follows, therefore, that externally sponsored research that seeks to bring health benefits, should, with appropriate safeguards, be encouraged in developing countries.