Realizing Benefit Sharing: Is There a Role for Ethics Review? - Benefit Sharing - page 185

8.3.3 US Withdrawal from Post-study Obligations
The previous chapter suggested that an expansion of the provisions of the CBD to
include human biological resources would close an important gap in the international
legal framework. It would establish an inclusive approach to biodiversity, both human
and non-human, bring legal clarity to a contentious area and, most importantly, pro-
vide a way forward when a spectrum of genetic resources are used by various indus-
tries (e.g. when a product is developed using plant and human genetic resources).
As noted in the beginning of this chapter, the US is virtually the only country
that is not a party to the CBD. At the same time, the US is the leading innovation
economy in the world. For instance, the 2011 World Intellectual Property Indicators
showed that 24% of all patents world-wide were granted by the US Patent and
Trademark Office (WIPO 2011 ). In 2008, however, the US government effectively
opted out of the Declaration of Helsinki when the US Food and Drug Administration
discontinued its reliance on the declaration and issued independent Guidelines for
Good Clinical Practice. The new guidelines omit the two standard benefit-sharing
principles of the Declaration of Helsinki, namely post-study access to successfully
tested interventions and the requirement that research, particularly in developing
countries, must benefit local communities and be responsive to local health needs
(Kimmelman et al. 2009 ). This means that US government requirements for the treat-
ment of research participants are now in direct conflict with the prescriptions of the
Declaration of Helsinki (aside from the fact that the US is not a party to the CBD).
This development could mean that US research ethics committees (or institutional
review boards) will in general put less pressure on researchers to describe compliance
with post-study obligations in study protocols than their international counterparts
that fully subscribe to the Declaration of Helsinki. While this is a serious concern,
resource provider states are not entirely powerless in relation to compliance where
they rely on ethics review. US researchers, like any others, require local ethics review
in order to access human genetic resources. Such local ethics review (for instance
in Kenya, Thailand or Bolivia) can, if well informed and decisive enough, provide
approval only on condition that benefits to research participants and local communi-
ties are explicitly articulated. This strategy presents a distinct advantage over CBD
expansion. In fact, strong ethics committees or national legislation in developing
countries (see for instance Brazil's benefit-sharing legislation as outlined in Chap. 3 )
can enforce benefit-sharing compliance now , without additional legal frameworks.
8.3.4 Timeliness of Research
A related advantage of utilizing ethics review to achieve benefit-sharing compli-
ance is that the procedure needs to be undertaken by researchers in any case. For
instance, informed consent documentation and risk-benefit ratios will always be
checked by an ethics review committee whether or not benefit sharing is also regu-
lated through independent mechanisms. Adding benefit-sharing information to that