Populations who are terrified by
the progress of the epidemic, and
who lack trust in health-care and
aid workers, and in public authorities
in the aftermath of civil
wars, cannot be expected to offer
informed consent to such randomised
trials.12(p1423)
Misunderstandings can further
contribute to fear and mistrust;
yet, since informed consent is
essential, examination of these
and other specific obstacles is
crucial to know how to address
such barriers. Hence, research on
how best to convey the complexities
of these trials in participants’
local languages—what terms and
concepts to use—is critical to avoid
these miscomprehensions. Participants
will have to understand, in
their own languages (several of
which are spoken in the three
countries most affected by this
outbreak) the particular experimental
nature of these interventions—
the fact that these products
may not work. Participants in the
developing world and elsewhere
often miscomprehend key aspects
of studies, and forward and back
translation do not always ensure
effective communication and
comprehension.13 For instance,
even after providing informed
consent through a detailed process,
more than 80% of participants
in a malaria vaccine trial did
not understand basic concepts
such as placebo, randomization,
and the ability to withdraw from
research participation without
negative consequences to themselves.14
In some sub-Saharan African
languages, for example,
a word may exist only for “cure,”
but not for “experimental drug
trial,” “placebo,” “randomization,”
or “vaccine.”
11 Hence, determining
how best to convey these concepts
in local languages will take considerable
effort, and will not necessarily
be easy.
If favipiravir (with its only partial,
but not complete effectiveness),
or other early tested drugs
that may also prove to have only
limited effectiveness, are used
more broadly, research will be
especially vital to ensure that local
populations do not assume that
these products are more protective
than they in fact are. Such
overestimations of these products’
benefits could lead not only to
additional exposures of oneself or
others, but to demand for these
drugs that could undermine beneficial
ongoing and future trials of
other possible treatments (e.g., serum
transfusions). Potential participants
might decline to enroll in
studies examining other experimental
treatments that may prove
to be even more effective. These
issues are important since the
disease incidence may be decreasing
somewhat (though
remaining at worrisome levels),
making recruitment of participants
into studies more difficult.