The ethics of clinical and epidemiological research.

The global burden of tuberculosis (TB) demands that research be undertaken. The vulnerability of the populations most at risk for TB demands that such research be subject to ethical review to protect their rights and interests. In this brief article we cannot review the vast and important literature bearing on the ethics of clinical and epidemiological research and public health surveillance. Instead, we have focused on three questions that have been at the center of discussion and debate and which have special relevance for TB. First, we examine a question that has special bearing when wealthy nations or international organizations carry out research in poor countries: what does justice require in the post trial period? Second, we examine the question of how the principles of consent and confidentiality may require modification in record-based epidemiological research. Third, we look at the challenges posed by public health surveillance, which in many cases requires case reporting by clinicians to public health agencies. By way of conclusion, we take note of the centrality of enhancing the institutional capacities for ethical review of research in poor nations.