Biology Reference
In-Depth Information
and regional bodies have formulated guidelines based on the ethical principles that
are contained in the declaration.
11
However, today the WMA represents physicians
from 97 countries.
12
Hence, of those organizations currently involved in the for-
mulation of guidelines, the WMA has by far the most reasonable claim to be taken
seriously.
13
Since its adoption, the Declaration of Helsinki has undergone a number of
revision processes, the latest in October 2008. The current declaration directly
addresses issues related to benefit sharing and post-study access to any products
developed. The relevant paragraphs are discussed below.
3.3.2 Benefit Sharing in the Declaration of Helsinki
It is evident from the earlier discussion of the definition of benefit sharing (see
frameworks are currently in place. The prevailing approach to benefit sharing for
providers of human biological resources such as DNA or blood samples is the
prescription of post-study obligations. Essentially, these obligations (previously
known as post-trial obligations) describe a duty to provide human research par-
ticipants with access to a proven beneficial health care intervention after a study
has been concluded. This means that in return for contributing to medical research,
the research participants are meant to obtain access to any resulting products or
interventions as a form of benefit sharing. Post-study obligations were first intro-
duced in the Declaration of Helsinki in 2000, when the WMA General Assembly
in Edinburgh adopted paragraph 30.
At the conclusion of the study, every patient entered into the study should be assured of
access to the best proven prophylactic, diagnostic and therapeutic methods identified by
the study (WMA
2004b
).
This early formulation of post-study obligations was restricted to patients and,
by implication, to clinical trials involving volunteers in need of treatment. As a
result, healthy volunteers who enrolled in clinical trials, as well as donors of bio-
logical materials, were excluded from benefit sharing. Both the limited scope and
the rigidity of this approach were criticized (Schroeder
2008
). For instance, if
post-study access to a drug is the only way to avoid the exploitation of research
participants, those who take part in studies that do not lead to the marketing of a
11
See Andanda (
2006
: 60-61) for a detailed discussion of this regime.
13
We agree with Udo Schuklenk on this claim. When comparing the Declaration of Helsinki
with other influential guidelines, Schuklenk argues that 'an international consensus among small-
ish operators with impressive names is not a sufficient reason to do away with the authority of the
WMA, which represents more members of the medical profession in one single country, let alone
across the world, than the rest of the organisations and institutions mentioned … combined'. See
Schuklenk (
2004
: 196).
