Realizing Benefit Sharing: Is There a Role for Ethics Review? - Benefit Sharing - page 183

between doctor and patient and that between researcher and research participant - is
that trust plays a major role and the relationship is often highly personal.
The breaking off of a relationship between researcher and research participant
can be very difficult, even traumatic. If, as is frequently the case in the developing
world, participation in a research study is the only way to access health care, then
the end of a study implies the end of health care. In particular, researchers work-
ing with AIDS patients often find it difficult to withdraw in the knowledge that
those patients are likely to die from a treatable disease (Shapiro and Benatar 2005 :
45). Needless to say, the sense of abandonment for the research participant is even
stronger, especially when the study provided the only access to health care. In the
worst cases, the end of the research results in death.
It is in this context that post-study obligations to research participants are advo-
cated. Focus group research conducted among patients, clinical researchers and
research administrators in Kenya showed that all stakeholders believed strongly
that researchers had a long-term obligation to participants. 'The rationale behind
this belief - whether fear of death, inability to continue therapy, or an ethical
obligation - warrants attention' (Shaffer et al. 2006 : 55). Focusing on the ethical
obligations, one would argue that research participants, having contributed to the
advancement of knowledge, deserve some benefit in return. This aligns with the
argument for non-exploitation as advocated throughout this topic.
Importantly, though, a number of participants in the focus groups noted spe-
cifically that the loss of access to health care would result in a general loss of trust
between research participants and researchers, potentially making the community
unwilling to participate in research at all (NBAC 2001 : 59). Both sides consider
it unacceptable to abandon, at the end of a study, research participants who are in
dire need of medical attention.
In terms of who has how much invested in the relationship, it might there-
fore make sense to allocate post-study obligations to researchers. However, these
could also be among the duties of research funders and sponsors, who, one would
assume, are best placed to find the resources to discharge such obligations.
One of the few countries with binding national law on post-study obligations
is Brazil (see Chap. 3 ) . In 1997, a resolution by that country's National Health
Council set the following stipulation:
Access to the medicine being tested must be assured by the sponsor or by the institution,
researcher, or promoter, if there is no sponsor, in the event its superiority to the conven-
tional treatment is proven (National Health Council 1997 : article IV.1(m)).
The Declaration of Helsinki lacks a similarly clear assignment of duties to a
specified group. One might argue that this allows the flexibility needed in guide-
lines that must apply all over the world. In practice, however, this flexibility is
partly responsible for the ineffectiveness of the guideline and the concomitant lack
of good practice examples for post-study obligations. If the commitment to benefit
sharing re-emphasized in the 2008 Declaration of Helsinki is to be effective, then
research ethics committees need to know whose duty it is to provide access to suc-
cessfully tested interventions or 'other benefits' in order to ensure compliance.