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8.6 Conclusion
Can compliance with benefit-sharing obligations as outlined in the Declaration of
Helsinki be achieved through ethical review? As we have seen, the obstacles are
manifold. In particular, post-study access does not seem to be a promising sce-
nario, given the unrealistic timeframes and the potential for injustice. 'Other bene-
fits' are a more realistic option, in particular the provision of comprehensive health
care during long-term studies. In order to strengthen the capacity of ethics review
to ensure benefit sharing, we submit the following recommendations:
• Research ethics committees and other parties need to know whose duty it is
to discharge post-study obligations. This could be specified in the Declaration
of Helsinki. Specification in national law (as in Brazil) is another possibility.
Solutions should be integrated with local health systems in developing countries
so that research sponsors and local authorities understand their specific roles in
providing health care to populations.
• Effective research ethics committees require adequate resources, training and
time to fulfil their important roles. As studies have shown, this cannot be taken
for granted in developing countries. There is already a pressing need to facilitate
innovative ways of offering training and education in research ethics. As well as supporting
and enhancing current training programmes it will be essential to build up a cadre of trainers
located in developing scountries, as well as establishing a process of mentoring for local eth-
ics committees (Bhutta 2004 ).
• In addition, further ways of providing inancial support to ethics committees in
developing countries need to be found.
• Applying post-study obligations to all types of research without further reine-
ment would be unlikely to achieve broad acceptance of the duties entailed and
may even lead to new injustices, in particular if valuable publicly funded
research tailored to Type III diseases 10 were abandoned in developing countries.
Such research could attract exemptions or waivers from post-study obligations,
as they already comply with fairness requirements.
• The tension between beneit sharing and undue inducement needs to be resolved
for developing countries. The ideal solution would be the global success of the
fair exchange model between the health care industry, human research partici-
pants and national governments: human research participants show solidarity
with others (Knoppers 2000 ; Berg and Chadwick 2001 ) by taking part in medi-
cal research and are rewarded, like their fellow citizens, with the fruits of medi-
cal progress, generated through industry and partly funded through national
governments. In such circumstances, concerns about undue inducements would
be restricted to substantial monetary rewards and other excessive remunerations.
• However, as long as this ideal solution remains no more than an aspira-
tion, ways must be found to avoid the exploitation of research participants in
10 Type III diseases are those that occur exclusively or overwhelmingly in poor countries.
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