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International News
Local Collaboration Key to Success of Health Research in Poor Countries
Psychiatric News
Volume 42 Number 21 page 1-22

A summary of major ethical, social, and cultural issues in conducting scientific research and promoting technologies in developing countries provides a framework to help guide large-scale global research and health initiatives, especially those conducted in developing countries.

The Ethical, Social, and Cultural (ESC) program, a component of Grand Challenges in Global Health (GCGH), a large, nonprofit, international project aimed at "solving critical health problems in the developing world," highlights 13 major issues that can arise in conducting health research and public health initiatives in developing countries. The program, based at the University of Toronto in Canada, has gathered a group of international bioethics experts and researchers to advise and assist in GCGH's efforts throughout the world. Four articles on the ESC program, including a summary of issues, are published in the September PLoS Medicine, a peer-reviewed, open-access journal published by the nonprofit organization Public Library of Science.

As scientific research becomes increasingly global and more clinical trials are outsourced to underdeveloped countries, ethical concerns for the protection of human rights have grown. Even well-meaning philanthropic aid programs conducted by wealthy nations can result in suspicion, resentment, and negative outcomes if the administrators are ignorant of local cultures and geopolitical issues, the ESC program advisors pointed out.

The lack of research oversight by local governments, varying standards of ethical conduct, and economic disadvantages may place people at risk for exploitation and harm, the report noted. The ethical problems and controversies in AIDS research in Africa, for example, have drawn criticism that researchers and sponsors treated subjects in poor African countries using ethical and medical standards lower than those that would be expected in the United States or other affluent countries.

The issues that are cited by ESC advisors range from the need to engage the local community to women's social status in specific places, and obligations/benefit sharing once a clinical trial is completed (see Research Issues That Are Critical in Developing Countries). The ESC experts maintain that researchers should maximally communicate and collaborate with the local community, as well as with public, government, and nongovernmental organizations. Ignorance about local cultures and preferences could lead to failure, such as the rejection of white antimalaria bed nets in places where white is a culturally sensitive color.

The concerns were compiled on the basis of interviews and group discussions with research investigators and program officers within GCGH and surveys of experts from academia, governments, nongovernmental organizations, and the private sector in developing countries. This is the first analysis of ethical, social, and cultural issues related to large-scale research and public health initiatives that specifically addresses the developing world, according to the authors.

"It is important to distinguish between issues unique to international research and issues that are relevant to research in all settings, including studies done in developed countries," Paul Appelbaum, M.D., chair of APA's Council on Psychiatry and Law, told Psychiatric News. Appelbaum is the Elizabeth K. Dollard Professor of Psychiatry and director of Medicine and Law in the Division of Psychiatry, Law, and Ethics in the Department of Psychiatry at Columbia University; he has written extensively on bioethics.

Collaboration with a local community, for example, is essential to any research setting. One issue raised by the ESC program "particularly salient to the underdeveloped world is whether research participants and the hosting community will benefit from the research outcomes and results. The products of many research studies are so expensive that there is little hope the [host] countries will have wide access to them. It is a major issue in international research and not easy to resolve," Appelbaum said.

An important concern not covered by the list, he noted, is the complex issue of informed consent in rural and poor regions. "One difficulty is how different cultures understand the concept of consent. The idea of choice may be incomprehensible in some cultures where authority carries great weight with the population. Researchers and physicians may represent an authority figure, and people may find it difficult or feel powerless to refuse participation in a study."

He explained that some potential research subjects may not be in a position to make entirely voluntary choices, especially women in places where they need the approval of male figures such as fathers and husbands to participate in a study. There may also be situations in which a male figure can compel a woman to participate in a study against her will. Language barriers and a profound lack of understanding about science in underdeveloped regions can also hinder people's ability to make truly informed decisions.

The GCGH is supported by the Bill and Melinda Gates Foundation, Canadian Institutes of Health Research, Foundation for the National Institutes of Health, and Wellcome Trust. The goal of the initiative is to "achieve scientific breakthroughs against diseases that kill millions of people each year in the world's poorest countries." The projects focus on developing new and better vaccines, preventing insect-transmitted diseases, discovering solutions to drug resistance, and more accurately diagnosing and tracking diseases in poor countries.

"Grand Challenges in Global Health: Ethical, Social, and Cultural Issues Based on Key Informant Perspectives" is posted at<medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0040268>.

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