Leslie London’s article on ethical oversight of health research is a
welcome addition to the current discourse on collaborative research
(research being sponsored by wealthy nations and conducted in resource
poor settings of developing countries).1 The author has raised some
important considerations that should affect ethical review process:
research protocols that may not be in conjunction with local ethical
codes, cultural appropriateness of research, and the potential of study
populations being exploited by these studies.
Although, these add to the ongoing debate about the ethical concerns
of review processes involved in such research,2,3 little empirical work
has been done to explore the experiences and attitudes of researchers from
developing countries involved in collaborative research. Such work is a
step towards recognizing the agency of another potentially vulnerable
group—developing country researchers—in the global dialogue. One
contribution was our study, which was part of a larger survey of US and
developing country researchers sponsored by National Bioethics Advisory
Commission (NBAC) 4. The study involved a self-administered survey with
169 questions and nine domains of inquiry sent to over 500 researchers in
Africa, Asia, and Latin America. 203 completed surveys were analyzed.
Details of the methods, sample, and survey are available elsewhere 4.
One objective of the study was to explore the experiences and
attitudes of researchers from developing countries regarding institutional
review boards (IRBs). A majority of researchers agreed that US ethical
regulations (as of 1998-99) governing human subjects ensure high ethical
standards, and that developing country collaborators rely on US ethical
rules for guidance. At the same time a majority of respondents they voiced
their concerns regarding US IRBs being insensitive to local cultural norms
and traditions. Slightly more than half of the researchers thought that
US, as well as developing country IRBs, are sometimes to always more
concerned with politics than with protecting the interests of research
subjects. Nearly two-thirds of the researchers agreed that international
guidelines should be used for ethical reviews in developing countries
instead of US regulations.
Such empirical work provides an important insight about the opinions
of researchers in resource-poor and low-income countries, and avoids
assumptions about their attitudes. Similar explorations are critically
needed for others vulnerable groups, such as research participants and
communities in developing countries. This defines an important research
agenda in the field of research ethics.
References:
1.London L. Ethical oversight of public health research: can rules and
IRBs make a difference in developing countries? Am J Public Health. 2002;
92: 1079-1084.
2.Barry M. Ethical Considerations of Human Investigation in Developing
Countries: the AIDS Dilemma. N Engl J of Med. 1988; 319: 1083.
3.Angell M. Ethical imperialism-ethics in international collaborative
clinical research. N Engl J of Med. 1988; 319: 1081-1083.
4.Lurie P, Wolfe S M. Unethical Trials of Interventions to Reduce
Perinatal Transmission of the Human Immunodeficiency Virus in Developing
Countries. N Engl J of Med. 1997; 337: 853-855.
5.Kass N, Hyder A. Attitudes and Experiences of U.S. and Developing
Country Investigators Regarding U.S. Human Subject Regulations. Bethesda,
MD. National Bioethics Advisory Commission. 2001.