Biology Reference
In-Depth Information
Table 10.1 Challenges for Post-Study Obligations
Post-Study Access
Alternative Beneits
The delay between a study and the availability
of a successful intervention makes post-
study obligations unwieldy
Alternative benefits might violate prohibitions
against undue inducement and the commodi-
fication of the human body
Those taking the highest risks (clinical trial
stage 1) have the lowest likelihood of receiv-
ing interventions because of the low success
rate in pharmaceutical product development
Alternative benefits require a process of negotia-
tion for the most appropriate benefits. This
poses challenges of determining whom to
negotiate with and of studies possibly being
The Declaration of Helsinki does not specify whose duty it is to discharge post-study obligations
The Declaration of Helsinki treats every study alike - whether it is, for example, a publicly
funded investigation of tuberculosis or a commercially funded effort to research Alzheimer's
The US Food and Drug Administration's decision in 2008 to opt out of the benefit-sharing
requirements of the Declaration of Helsinki and prioritize its own more limited guidelines has
had a widespread impact on research governance
Important research on diseases of the poor might not be undertaken if bureaucratic and financial
burdens increase further
Post-study obligations can be regarded as a reactive attempt to address the most blatant exploita-
tion, when the human right to access to health care should be tackled in a much more system-
atic manner
In the context of donated human biological resources, alternative benefits
are the more promising benefit-sharing tool. Post-study access to a success-
fully developed product might make ethical sense, for instance, for HIV-positive
patients testing a new antiretroviral drug. However, the donation of biological
resources occurs so early in the research process, and may be related to so many
different interventions and uncertain future outcomes downstream, that returning
benefits in the form of access to successful products may be unachievable, even
with the best of intentions. With this tool as the means, too many donors would
still receive no benefit at all.
One might argue that the Indonesian case discussed in this topic (see Chap. 5 )
demonstrates that post-study access is precisely what is owed to Southern provid-
ers of resources. However, a closer look shows that the problem is more complex.
10.3 Benefit Sharing Versus the Human Right to Health
The Indonesian case (see Chap. 5 ) shows that while human biological resources
can be used in the development of new products (e.g. a vaccine), these products
may not be accessible to the local populations that contributed to the research.
This was the argument used by the Indonesian government when withhold-
ing avian flu samples from World Health Organization (WHO) laboratories.
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