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February 24, 2004

Ethical Review of Research in Developing Countries Needed

Developing countries need to more thoroughly review the research ethics of studies being conducted in their country but sponsored by more developed countries, according to a study conducted by researchers from the Johns Hopkins Bloomberg School of Public Health. In one of the first studies of its kind, the researchers looked into the controversy surrounding institutional review board examination of studies and the ethics of biomedical research sponsored by wealthy nations, but conducted in resource-poor countries. The study, “Ethical Review of Health Research: A Perspective from Developing Country Researchers” is published in the February 2004 issue of the Journal of Medical Ethics.

HyderLead author, Adnan A. Hyder, MD, MPH, PhD, an assistant professor and the Leon Robertson Faculty Development Chair in the School’s Department of International Health, said, “Concerns about the potential exploitation of resource-deprived countries have emerged with the increase in research collaboration between industrialized and developing countries. Our study highlights the great need for further thinking and dialogue on research conducted in the developing world and funded by high income countries. There is also a critical need for research ethics capacity development in the developing world.”

The study authors surveyed 203 health researchers from developing countries in Africa, Asia, and Latin America about their concerns and opinions regarding ethical review processes and the performance of developing countries and U.S. institutional review boards. A majority of the study participants were male, senior researchers who conduct research on a part-time basis. The questionnaire addressed issues regarding institutional review boards and informed consent and tested specific recommendations with respondents.

Forty-four percent of the survey respondents said that their studies were not reviewed by a developing country’s institutional review board or Ministry of Health. Of those studies that were reviewed, 92 percent said they were reviewed only at the local institutional level. Sixty-nine percent of the U.S.-funded studies were required to receive an ethics review by the study’s host country. Forty-four percent of the studies were funded by the United States and U.S. non-profit organizations were the largest single funding source.

Questions about the need for local language consent forms and letters of approval and confidentiality of participants was asked for by U.S. institutional review boards significantly more than by host countries. For those studies that were reviewed by local host country institutional review boards, the areas of most concern were cultural appropriateness of the studies, need for local language consent forms, relevance of research questions to the country where research was being conducted and the availability of interventions for the host country after the study was completed.

Dr. Hyder, also a faculty member of the Phoebe R. Berman Bioethics Institute at the Johns Hopkins University, said, “Not only do ethics reviews need to be a standard in collaborative research in both the host and donor country, but international guidelines for collaborative and multi-national research projects are needed. It is also important to make sure that there is a strong voice from the developing world in all discussions pertaining to this issue and that such discourse is not dominated by well meaning experts from high income countries.”

The study was commissioned by the former National Bioethics Advisory Commission of the United States. It is part of a larger project that surveyed developing country and U.S. researchers about their experiences and attitudes towards human subjects regulations and the ethical issues that arise in their work.

Salman A. Wali, MD, MPH, Agha N. Khan, MD, MPH, and Noreen B. Teoh, MPH, all with the School’s Department of International Health, Nancy E. Kass, ScD, with the School’s Department of Health Policy and Management, and Liza Dawson, with the Phoebe R. Berman Bioethics Institute, co-authored the study.

Public Affairs Media Contacts for the Johns Hopkins Bloomberg School of Public Health: Kenna Brigham or Tim Parsons at 410-955-6878 or Photographs of Adnan Hyder are available upon request.