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Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings

1 Sep 2007

Review published in the "Special Topics in Social, Economic and Behavioural (SEB) Research" Series, No. 5, published by the Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva.

Available online PDF at: www.who.int

This review considers ethical challenges to research design and informed consent in biomedical and behavioural studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations.

Professional and public debates concerning the application of guidelines for ethical conduct in studies carried out in developing countries are likely to continue as new information becomes available. Researchers in biomedicine, public health, and the social and behavioural sciences confront the challenging task of adhering to national and international regulations in social and cultural environments in which ethical guidelines may not be easily translated or applied. Increased awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings is needed. But strengthening professional knowledge about international research ethics is not enough. Investigators also require practical advice on the best methods or models for articulating ethical guidelines in the field. Empirical research on a wide range of issues relevant to the application of ethical guidelines is needed, including studies of macro social and economic developments that drive the globalization of the biomedical research enterprise. Technological and financial resources are also necessary to build capacity for local collaborators and communities to ensure that results of research are integrated into existing health systems. This requires collaborative efforts and engaged commitment on the part of investigators, funding agencies, policy-makers, governmental institutions, and industry.