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
"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>.▪