Biology Reference
In-Depth Information
have at all stages given individual consent to their participation in the ongoing studies,
which use their blood, cervical, vaginal and saliva samples.
23
However, they have
retained no right of ownership over any donated samples or knowledge accrued from
them, and therefore no negotiating rights regarding any subsequent developments.
5.3.3 The Legal Situation
Research involving human subjects is bound by various international guidelines,
most prominently the Declaration of Helsinki (WMA
2008
) and the Council for
International Organizations of Medical Sciences (CIOMS) guidelines (CIOMS
2002
). These are not enforceable legal instruments, but constitute the most author-
itative statements on medical ethics, influencing the formulation of international,
regional and national legislation and professional practice. The legal situation with
regard to benefit sharing for human biological resources is discussed in
Chap. 3
.
In relation to the Majengo case, the national law of Kenya and UN guidelines that
apply to HIV/AIDS research are also relevant.
Although Kenya has put regulations in place to govern access to non-human
genetic resources and subsequent benefit sharing, currently no such policy or regu-
lations exist for the use of human genetic resources (Minister for Environment and
Natural Resources
2006
).
24
However, in 2005 Kenya developed national
Guidelines for Research and Development of HIV/AIDS Vaccines (Ministry of
Health
2005
) in response to the Majengo case. Although the sex workers have not
themselves been involved in vaccine trials, the guidelines are relevant because the
women's research participation led to the development of experimental vaccines.
The guidelines provide an enabling framework for addressing issues of financial
compensation for participants through material transfer agreements and research
and development agreements. It has been argued that benefit-sharing agreements
could effectively be incorporated into the cooperative research and development
agreements (Ministry of Health
2005
: 44 section 8.3; see also Andanda
2008
:
173). The agreements would then be binding and enforceable in domestic law.
Paragraph 4.2 of the Kenyan guidelines, which stipulates the terms of refer-
ence for science and ethics committees in the country, requires such committees
to verify the ethical integrity of HIV/AIDS vaccine trial protocols in accordance
23
Issues have been raised concerning the difficulties of communicating adequate information
for obtaining meaningful consent from potential participants, given the difficulties of translating
complex concepts into languages that may not (yet) have the linguistic resources to communicate
those. '[T]he moment you begin to talk about even translating into a language that the subject,
the participant understands, you find that most words do not exist here … so there is a problem
of the concepts' (interview with Kenya Medical Research Institute (KEMRI) Ethics Committee
member, GenBenefit, Nairobi, April 2007).
24
Interview with an official at the Ministry of Health (MoH), Kenya, GenBenefit, April 2007.
