Biology Reference
In-Depth Information
If the emphasis in the Declaration of Helsinki is on
post
-sharing of benefits,
some of the challenges of securing post-study access (for example, the unrealistic
timeframe) would now also apply to 'other benefits'. In other words, if only those
benefits delivered
after
a study is completed count towards benefit sharing, seek-
ing compliance through an ethics review committee could become difficult, as the
committee usually ceases its monitoring work once the research is complete.
Second, offering access to health care as a benefit to participants could violate
undue inducement prohibitions, a topic we have considered before (see
Chaps. 2
and
5
). When undertaking research on economically disadvantaged or otherwise
vulnerable populations possibly suffering from hunger or malnutrition, and lack-
ing access even to elementary health care, any prospect of health care (for exam-
ple, a general check-up as part of being enlisted in a study) can be regarded as
an undue inducement. It is no surprise that UNESCO's Universal Declaration on
Bioethics and Human Rights includes two requirements of benefit sharing: first,
that '[b]enefits resulting from any scientific research and its applications should be
shared with society as a whole and within the international community, in particular
with developing countries', but, secondly, that those '[b]enefits should not consti-
tute improper inducements to participate in research' (UNESCO
2005
: article 15).
Some international guidelines, such as the International Ethical Guidelines
for Biomedical Research Involving Human Subjects issued by the Council for
International Organizations of Medical Science (CIOMS), accept that research
participants may receive free medical services. However, CIOMS also notes that
these services should not be 'so extensive as to induce prospective subjects to con-
sent to participate in the research against their better judgment' (CIOMS
2002
:
guideline 7). And research has shown - unsurprisingly - that the need to access
medical services can amount to pressure to join research studies in developing
countries. One cannot reliably determine how many participants actually take part
'against their better judgement', but it is clear that many feel they effectively have
no choice. As one of the Majengo research participants said, 'I don't know what I
will do if they close down.'
When 347 Ugandan parents with children enrolled in a malaria study were
asked whether they had felt coerced to join, more than half said they had 'felt
pressure to enrol their children because of the child's sickness' (Pace and Emanuel
2005
). As Annas and Grodin (
1998
) have formulated it,
in the absence of health care, virtually any offer of medical assistance (even in the guise
of research) will be accepted as 'better than nothing' and research will almost inevitably
be confused with treatment.
Ironically, strict prohibitions against undue inducement lead to a rather para-
doxical result. The poorer a community is, the smaller the benefits that can be
offered without potentially exercising undue influence on the decision to par-
ticipate. The conflict here occurs because participants are meant to be protected
against undue inducement on the one hand and exploitation on the other. Yet limit-
ing benefit-sharing possibilities gives research sponsors who outsource research to
developing countries a convenient 'ethical' argument for limiting the benefits to
