Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

Over the past few decades, there has been increasing attention focused on the ethics of health research, particularly in low- and middle-income countries. Despite the increasing focus on the literature addressing human protection, community engagement, appropriate consent procedures and ways to mitigate concerns around exploitation, there has been little discussion about how the duration of the research engagement may affect the ethical design and implementation of studies. In other words, what are the unique ethical challenges when researchers engage with host (...) communities for longer periods (10 years or more), and what special considerations does this time commitment generate when applying ethical principles to these kinds of studies? This article begins to outline key areas of ethical concern that arise during long-term, sustained research activities with communities in low-resource settings. Through a review of the literature and consultations with experts in health systems, we identified the following key themes: fair benefits and long-term beneficence; community autonomy, consultation and consent; impacts on local health systems; economic impacts of research participation; ethical review processes; and institutional processes and oversight within research organizations. We hope that this preliminary exploration will stimulate further dialogue and help inform ethical guidance around long-term research engagements in the developing world. (shrink)