Biology Reference
In-Depth Information
drug (perhaps because it was found to be ineffective) are excluded from receiving
any benefits. (We shall return to this in Chap. 8 .)
In 2004, the WMA's General Assembly in Tokyo added a note of clarification
on paragraph 30, which opened the way for other benefits instead of post-study
access to successfully tested interventions.
The WMA hereby reaffirms its position that it is necessary during the study planning pro-
cess to identify post-trial access by study participants to prophylactic, diagnostic and ther-
apeutic procedures identified as beneficial in the study or access to other appropriate care
(WMA 2004a ).
To reduce the rigidity of post-study access to successfully tested drugs, the
phrase 'access to other appropriate care' was added. At the same time, the term
'patients' was changed to 'study participants', to allow for the inclusion of healthy
volunteers. However, the term 'trial' was retained, thus limiting benefit sharing to
those taking part in clinical trials. This changed in the 2008 declaration, adopted in
Seoul, articles 14, 17 and 33 of which relate to benefit sharing.
Paragraph 14 of the 2008 version of the Declaration of Helsinki deals directly
with the issue of broadening the scope of beneficiaries from clinical trial partici-
pants to study subjects and is therefore much clearer.
The protocol should describe arrangements for post-study access by study subjects to
interventions identified as beneficial in the study or access to other appropriate care or
It follows, then, that all medical research involving human subjects which
needs approval from an ethics review body should describe, in its study proto-
col, post-study access to successfully tested interventions or other benefits. This
implies that donors of biological samples could be included among the possible
beneficiaries, as the scope is not limited to 'trials'.
However, such a formulation gives rise to a practical concern, namely that com-
pliance with it could mean that any arrangement for post-study access would suf-
fice, as long as it was detailed in the study protocol. Even the sentence 'There are
no arrangements for post-study access,' could arguably be regarded as compliance
in that, as long as study participants and ethics review bodies know that there is no
provision for post-study access, sufficient compliance with paragraph 14 would have
been achieved. Hence this obligation could be called informational rather than sub-
stantial, in which case it does not satisfy the wider demand for benefit sharing.
At first sight, this concern seems to be mitigated through paragraph 33 of the
At the conclusion of the study, patients entered into the study are entitled to … share any
benefits that result from it, for example, access to interventions identified as beneficial in
the study or to other appropriate care or benefits (WMA 2008 ).
This paragraph implies that post-study obligations are a substantial rather than
an informational demand for all medical research involving existing patients .
However, that still seems to leave healthy volunteers and donors of human biologi-
cal samples potentially excluded from any post-study benefits, as benefit sharing
is only envisaged with patients, rather than all participants in medical research.
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