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.
