Biology Reference
In-Depth Information
This would seem contrary to the spirit of benefit sharing as understood through
the CBD, which aims to reward 'resource providers' in particular in order to avoid
concerns about exploitation.
Here one needs to remind oneself of the purpose of benefit sharing for human
genetic resources. As noted in
Chap. 2
's section on exploitation, formal benefit-
sharing frameworks such as the CBD or the Declaration of Helsinki are only
required where participants contribute to research but derive no benefits at all. In
developed countries, medical research is covered by what we term a fair-exchange
model. Human sample donors contribute to research and in return have access
to increased medical interventions, tailored to local health needs, to achieve and
maintain their health. Where this model fails, as it does in developing countries
where the health infrastructure does not support broad access to health care, other
solutions have to be found. In this regard, one could argue that such solutions are
only required for vulnerable populations - and this is the approach taken by the
Declaration of Helsinki through paragraph 17.
Medical research involving a disadvantaged or vulnerable population or community
is only justified if … there is a reasonable likelihood that this population or community
stands to benefit from the results of the research (WMA
2008
).
This means that when ethics review bodies are presented with proposed studies
on vulnerable groups which do not fall under the category of 'patients', they still
need to ensure that the research population or the wider community stand to ben-
efit from the research. Hence, a study protocol which notes that there is no provi-
sion for post-study access or alternative benefits would be unethical, according to
paragraph 17 (rather than paragraph 14), if it involved vulnerable populations. It
is evident that the latest declaration is therefore comprehensive in its benefit-shar-
ing clauses, in providing (somewhat intricate) frameworks on which arguments in
favour of benefit sharing with donors of biological samples can be based.
3.3.3 Feedback on the Outcomes of Research
The 2008 Declaration of Helsinki includes one other new aspect which could be
subsumed under benefit sharing, namely the requirement to provide feedback to
participants.
The right to feedback on the outcomes of the research has been provided for in
paragraph 33 of the declaration.
At the conclusion of the study, patients entered into the study are entitled to be informed
about the outcome of the study … (WMA
2008
).
Failure to give feedback on the results or outcomes of the research (whether
positive or negative) has been mentioned as one point of dissatisfaction with col-
laborative research in developing countries. An interview with the Kenyan
National Ethics Review Committee revealed the level of concern. 'The individual
[research participant] will never get to know what happened to the samples or
