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POSTGRADUATE COURSE IN BIOETHICS
Training Program Background Information

In the past decade, there has been tremendous improvement in funding for research into highly prevalent diseases of developing countries but a lot remains to be done. Some of the initiatives that have began to tackle these problems include the Roll Back Malaria project (RBM), President’s Emergency Plan for AIDS Relief (PEPFAR), Global Fund to fight AIDS, Tuberculosis and Malaria and the William J. Clinton Presidential Foundation but they have had varying degrees of success. The focus and funding on research and services for diseases like HIV/AIDS and malaria that are highly prevalent in developing countries has therefore increased. For example, the UNAIDS reports that while there was about US$330 million available for HIV/AIDS initiative in 1996, this has grown to $4.7 billion in 2003, even though some of these programs have fallen short of their funding goals. In addition to funding shortfall, programs have also been beset with problems associated with limited personnel and health care infrastructure with which to meet stated goals. Historical weaknesses in the health care system of developing countries have contributed to bottlenecks in distribution and utilization of funds. While limitations in clinical and laboratory practices have received significant attention, the impact of limited bioethics expertise is no less significant.

The need for bioethics experts: In the past few years, several well developed programs have run aground due to ethical problems that were not foreseen or were not handled with requisite skills and sensitivity when they occurred. Programs are threatened as much by ethical problems at the program preparation and implementation level as by program delivery and access. It is increasingly realized that a sound bioethics component is necessary in research proposals much the same way as statistical analysis sections are now required. Therefore a rapid up-scaling of bioethics expertise is needed to meet both current and projected needs.

Another emerging trend in global health is the exportation of clinical trials to developing countries. Often these involve treatment trials for conditions that rank lower in the health burden of developing nations and involve exploitation of weak regulatory environments and lower costs. These practices have generated many reports and proposals from developed countries but the little that has been heard from ethicists in developing countries are often negative and critical. Yet there is little doubt that these trials will continue for much the same reason that manufacturing is outsourced to developing countries. It is therefore important to increase the pool of bioethicists that can respond to the challenge of developing appropriate ethical guidelines, monitor and advice on the implementation of these projects.

Because of the “Out of Africa” theory of human evolution, the continent holds particular interest for genetic studies and the creation of databases for the study of population history and gene-disease association. This has encouraged genetic epidemiological studies of African populations yet such studies have raised questions, particularly about ability of participants to understand consent documents about complex research, risk of exploitation and relevance of such studies to developing countries’ health burden. Given the promise of genomics and other biotechnologies such as pharmacogenomics and nanotechnology to improve public health in developing countries, these studies are likely to increase in future. The role of public education educationists and bioethicists in enlightening the population and reducing ethical conflicts in the implementation of these new technologies has been stressed.

The need for biomedical researchers to have ethics training: It is recognized that the myriad of health and social problems as well as the growing influx of research dollars notwithstanding, programs to effectively protect research participants in Africa are nonexistent, weak or non-functional. Most research publications from African biomedical researchers are self-financed and are often not submitted for IRB evaluations (personal observation). This is particularly common because protocols are often not written for peer review and research proceeds as catch as catch can. The prevalence of research ethics violations in such situations is likely to be more widespread than 33% reported in a recent study of NIH funded researchers where despite the potential for serious career and financial jeopardy, ethics violations were rather common. It was suggested that these widespread mundane “regular” abuses are more damaging to science on the long run than the big ethics scandals. The report concludes that efforts to foster integrity among scientists should go beyond teaching about falsification, fabrication and plagiarism (FFP) to consideration of methods of fostering an ethical scientific working environment.

The need to create an ethical environment for scientific work: Corruption, plagiarism and lack of accountability are rampant in educational and scientific establishments in developing countries. The causes of these include years of bad government, autocratic rule, economic depression, poor institutional governance, loss of university traditions, history and tradition of subservience to authority, lack of transparency and lack of quality assurance systems among others. The HIV pandemic and attendant social problems are providing opportunities in developing countries for some biomedical researchers to conduct ethically questionable research on an unsuspecting population. This form of exploitation of research participants may be more widespread particularly when the researcher is also the heath care provider. Ethical problems are also arising from increasing sophistication of some research being conducted in developing countries; often countries with different ethical and cultural traditions than the West.

Given this background a multi-pronged approach to research ethics training in West Africa is necessary. This should include training that will lead to production of bioethics experts, training of IRB members and development of IRBs, training of biomedical researchers in ethical conduct of research and the creation of ethical working environments for scientists and a general increase in awareness of Bioethics by the population.

 
 
 
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