Realizing Benefit Sharing: Is There a Role for Ethics Review? - Benefit Sharing - page 182

critical attention, which returns us to the question: could research ethics commit-
tees ensure compliance with post-study obligations (a form of benefit sharing), in
order to avoid burdening medical research with further governance structures?
As African bioethicist Godfrey Tangwa notes:
In medical research the principle of justice demands fairness in the treatment of individu-
als and communities and the equitable distribution of the burdens and benefits of research.
This has important implications for such issues as … post-study benefits, and long term
access or distribution of the benefits of the study. These are the issues, which preoccupy
every research ethics committee sitting to review a health research protocol in Africa
today (Tangwa 2009 : S5).
When assessing the question of how justice might be secured within current
regulatory frameworks, it is essential to distinguish between two types of bene-
fit-sharing arrangements which have different compliance challenges associated
with them. First, we shall consider obstacles to enforcing post-study obligations
which aim to provide a successfully tested health care intervention to research
participants after the study has been concluded. We term this duty 'post-study
access'. Second, we shall analyse obstacles to enforcing the provision of benefits
not directly linked to the study, such as access to health care, support for the local
health infrastructure or health information campaigns. These will be referred to as
'other benefits'. We shall discuss first the challenges that apply to both benefit-
sharing types, and then those that apply exclusively to either type.
8.3 Post-study Access and Other Benefits
The following challenges to implementing a benefit-sharing framework of post-
study obligations apply both to giving research participants access to successfully
tested interventions and to the provision of 'other benefits'.
8.3.1 Whose Duty?
The Declaration of Helsinki does not specify whose obligation it is to discharge
post-study obligations. Is it the duty of individual researchers? After all, they are
the interface between sample donors on the one hand and research studies on the
other. They are also the ones with the most to gain, aside from research partici-
pants. Unlike physicians, whose prime duty is the promotion and safeguarding of
patient health, researchers have potentially competing obligations to their spon-
sors, as well as aspirations to achieve scientific progress.
While the Declaration of Helsinki clearly stipulates that '[i]n medical research
involving human subjects, the well-being of the individual research subject must take
precedence over all other interests' (WMA 2008 : paragraph 6), such 'other interests'
cannot be ignored altogether. What is, however, identical in the two relationships - that