Increased attention has been focused on the ethics of research conducted in developing countries since the widely publicized debates concerning HIV perinatal transmission trials. Consequently, the National Bioethics Advisory Commission, an independent, Presidentially appointed commission, chose international research ethics as one of its initial four focus areas. This study was commissioned to provide data to the NBAC international report. This study examined the attitudes and experiences of US-based investigators who work in developing countries concerning the types of ethics issues they face in their work and whether they think US human subjects regulations make sense for work conducted in developing countries. Seven focus groups were conducted with researchers from academia, military, government, and industry. Surveys were sent to approximately 400 similar researchers. Preliminary findings indicate that respondents have worked in developing countries for a median of seven years and 88% consider their studies to be of minimal risk. 56% of participants in studies have six or less years of formal education. Researchers work in developing countries because conditions are more prevalent there and because they are personally interested in addressing global inequities in health. 73% use written consent forms, although 44% report that 20-60% of participants are illiterate, and 52% agree that the legal language of consent forms is meaningless to participants. 37% sought permission from a village leader. Researchers provided recommendations on how rules for US oversight should remain unchanged for work conducted in developing countries and where changes are needed.
Learning Objectives: 1. Will understand what types of ethics issues arise for US based researchers who work in developing countries 2. Will understand what the views of US based investigators are concerning the appropriateness of US human subjects guidelines for work conducted in other countries and cultures 3. Will be able to better debate the appropriateness of US human subjects guidelines for work conducted in other countries and cultures
Keywords: Ethics, International
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.