December 2011
University of Michigan

Ethical issues in international human subjects research have traditionally focused on respect and value for cultural differences and communication norms. However, increasingly greater attention is being paid to broad challenges faced by international communities, by inequity in funding areas important to low and middle resource developing countries and to larger issues of oversight for international studies. Many developing countries have recently enacted, or are in the process of enacting, human subjects research laws and guidance. These laws are new and untested. Some developing countries are beginning to fund research subject to their new laws. Complicating the situation is the fact that human subjects protections laws and guidance may not be known or followed at regional, local and country levels. UM PIs are directly affected by these issues and are asked to interpret, and to follow, a maze-like patchwork of ethical principles, research regulations and guidance in multiple countries. Some developing countries have experienced research harms and exploitation in controversial industry funded drug development studies. Whether or not negative reactions in these countries will extend to academic research is not yet clear. Countries without human subjects guidance or regulations have challenges when researchers from several developed countries, each following their own country’s regulations, are conducting research in the country. Ethical and practical issues arise for UM researchers working with researchers from other countries and if they observe noncompliance in another country.