Biology Reference
In-Depth Information
This guideline should be read together with the commentary to guideline 12,
which focuses on equity in the distribution of burdens and benefits. It emphasizes
that 'no group should be deprived of its fair share of the benefits of research, short-
term or long-term', and it notes that 'such benefits include the direct benefits of par-
ticipation as well as the benefits of the new knowledge that the research is designed
to yield'. In this regard, proponents of benefit sharing have argued that the
establishment of clinical trial infrastructure, including training of local investigators …
which would translate into much-needed research on diseases specific to developing coun-
tries at local level … should not be discounted (Tomossy and Ford
2006
: 29).
These considerations of what may be considered as benefits in terms of post-
study obligations are significant in the context of resource-poor countries where
most patients 'may have only limited or even no access to healthcare' and may not
have the voice to negotiate benefits (Zong
2008
: 183).
Zong argues that 'there is an increasing consensus that, in principle, partici-
pants in developing countries should continue to receive benefits originating from
the studies in which they enlisted beyond the research period'. She emphasizes that
the consensus is mainly based on the ethical principles of beneficence and justice as
reciprocity (Zong
2008
: 188). However, Zong also observes that how far the obliga-
tions of beneficence and reciprocity extend to participants in developing countries
remains contentious as there is no agreement on whether or not post-study provision
should be mandatory in practice (Zong
2008
: 189). The situation is made more com-
plex by the fact that ethics committees and institutional review boards face dilemmas
due to lack of consensus among guidelines. In addition, Phase I clinical trials, epide-
miological studies, and research focusing on basic scientific knowledge do not easily
translate into the development of new medicines and vaccines suitable for post-study
provision (Zong
2008
: 189; see also Nuffield Council on Bioethics
2005
).
The commentary on CIOMS guideline 10 specifically mentions sponsors' respon-
sibility to ensure post-study availability, but acknowledges the limitations of this in
relation to studies which aim at generating scientific knowledge as opposed to a com-
mercial product. In such cases, however, there should still be an assurance that the
scientific knowledge developed will be used for the population's benefit. This means
that the concept of 'benefits' should not be limited to access to commercial products,
but rather extended to include all knowledge that is gained from research.
Further commentary on guideline 10 provides that it is unethical to conduct
research in a particular country or community if there is good reason to believe
that the intervention will not be made available to the local population. This provi-
sion is in line with the requirement that research be responsive to the needs - in
particular, the health needs - of the participants and their communities. However,
'a rare exception' is made in relation to, for example, studies which are designed
to obtain preliminary evidence that a drug or a class of drugs has a beneficial
effect in the treatment of a disease that occurs only in regions with extremely lim-
ited resources, and which could not be carried out reasonably well in more devel-
oped communities. In such cases, the commentary indicates that 'research may be
justified ethically even if there is no plan in place to make a product available to
