International Biomedical Research and Research Ethics Training in Developing Countries



In recent years, international research collaborations have been growing rapidly. Multinational pharmaceutical companies and academic institutions have expanded their research to developing countries. This in part is driven by the increased awareness of health as a global issue, the challenges imposed by new and resurgent global epidemics, the increased demand for new treatments, and practical and financial considerations of the pharmaceutical industry. For example, a sharp increase in research in developing countries is largely due to the global HIV/AIDS epidemic and increased efforts to control malaria epidemic . In addition, institutions within developing countries are increasingly engaged in biomedical research in order to map local health problems and allocate limited resources to remedy those problems. However, this research is often poorly regulated and does not meet widely accepted ethical standards.

Ethical Relativism, Ethical Universalism and Ethical Pluralism:

Anthropological studies suggest that there are deep and widespread moral disagreements across different societies. Practices and actions that are regarded as morally unacceptable by one society may be regarded as acceptable by another. Prominent examples include polygamy and arranged marriages. These observations have led some anthropologists and philosophers to conclude that all moral judgments are relative to a particular culture or society. When applied to international biomedical research, this point of view implies that the ethics of a given study cannot be judged only by the standards developed in western cultures. This is because it is not possible to objectively determine the legitimacy of one culture’s value system over that of another. One consequence of this position is that ethical systems of host communities should have equal force to Western guidelines in governing the conduct of international research. For example, if a non-western society requires that women participate in research only if they have spousal.

Towards A Trans-cultural Ethical Framework for Biomedical Research:

From this impassioned debate about the ethics of international research, two ideas have emerged that are notable for their relevance and applicability: the need for trans-cultural research ethics, and negotiated or procedural pluralism. The first notion implies that an ethical framework for biomedical research should take into account the differences in ethical values and social norms across different cultures. The second notion builds on the first and recognizes that agreement on universal ethical principles need not constrain the means pursued in following them. That is, different approaches and strategies may equally facilitate the achievement of a single ethical standard or goa. Consequently, useful approaches to research can be reached through negotiations and dialogue between sponsoring agencies and visiting researchers, on one side, and scientists and representative from host communities on the other.

The Need for Adequate and Sustainable Training Programs in Research Ethics for Scientists in Developing Countries:

As international research has evolved, researchers from developed countries have become increasingly dependent on colleagues in the host countries to overcome linguistic and cultural barriers and to help implement research protocols. This assistance does not involve simply a correct translation of study protocols or informed consent documents, but implementing these documents in a culturally and socially appropriate manner. Untrained local researchers, therefore, may jeopardize not only the scientific merit of the study (e.g., by incorrectly translating a questionnaire item), but also its ethical standards. Two possible scenarios might be anticipated in this regard; both are problematic.

With Best Regards,
Alice Maria
Editorial Coordinator,
Journal of Clinical Research and Bioethics

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