This paper describes the process of development of a standardized
tool for informed consent for use by participants in clinical trials in
The Gambia – a context characterized by multiple languages and a
low rate of literacy .There is a relatively small body of literature on
the process of informed consent and adaptation to African
languages and it is pleasing that work is emerging in The Gambia .
The focus of the paper is largely around the validation process and I
feel that this aspect has been covered thoroughly . I feel however
that at times other important aspects are marginalized .
There is a sense that IC in any context cannot be a one size fits all
affair and clearly depends on the participants , the trial and the
complexity of the information to be conveyed. While certainly there
are core components in the the process which have been carefully
identified and isolated in this study, there is nevertheless a feeling
that issues such as gender, language and indeed the role of the
mediator (or in this case “trained field staff”)are very important . It is
not surprising that to date no standard or systematic tool has
emerged as each trial and indeed each context will have unique
characteristics. It is not so much the tool that it is important as the
management of the specific and interactional features which emerge
in an IC context . The challenge then for this paper is to show the
reader why and how we can use a standard tool effectively.
Unfortunately such factors are not really fully explored either in
relation to this study or to the literature . Thus a statement such as
“expectedly” (page 20 and page 21) there was an effect for
education , is ironically somewhat unexpected in the paper because
this argument has not been fully explored and in fact the paper does
not consider some of the relevant literature (eg Catherine Orrell‟s
work on the relationship between education and adherence) which
suggest just the opposite effect in Africa. The finding that there was
discriminative validity (as reflected in Table 4) suggests of course
that even despite the new tool, certain participants remain
vulnerable.
I feel a little frustrated because of my own interest and expertise in
this area that there is not further discussion on how some of the
demographic biases of this sample may influence the process.
Though the demographic bias is not surprising ,it would be
appropriate to suggest why and the impact of issues such as literacy
and autonomy of decision making in African countries (see also the
work of Godfrey Tangwa ) and there is also not discussion on the
differences (if any ) which might have emerged in the three
languages trialed in this study. I think it would be useful for the
reader to understand the disease profile of The Gambia and the
typical clinical trials that take place there.
It would also be interesting to have the role of the mediator better
explained. Though the tool is more standardized there was
nevertheless someone who was responsible for administering that
tool and that person‟s voice and activities appear to be “silent” in this
paper., How well did the participants understand the symbols? Why
were some items more difficult than others to understand and what
did the different trials demonstrate in this regard? While it certainly
adds to the validity that there were two trials on which this tool was
piloted it would be interesting to know if and how the items of the
scale were differentiated for the two trials .. With a sample of this
size I suspect that there were trends which emerged which might be
interesting to pursue .
It seems important to differentiate between interpreting (which refers
to oral aspects ) and translation which refers to written aspects and
the terminology should probably be changed in this study to better
reflect standard terminology.