By Esther Nakkazi
Uganda is one of the few countries over outsourced for
research involving human participants or clinical trials. With the hundreds of
trials held it is important for communities who participate to fully understand
informed consent.
The Ugandan National Council for Science and Technology
(UNSCT) http://www.uncst.go.ug/ on 11th
-13th July, held the 3rd annual national research ethics conference
and one of the issues they discussed was ethical issues in research with
communities.
With most of the research carried out among poor and
illiterate communities it was noted that it was important for communities to
fully understand informed consent.
One of the questions from the conference was ‘how do you
know that the participants have understood informed consent?’
Scientists then suggested that Uganda should have a standard
metric to measure or verify that communities have understood informed consent.
This would evaluate the prospective communities to verify that they have
understood the message passed to them for it.
Researchers reported that most times after explaining about
the consent process, participants hardly ask any questions, either a fact that
they have fully understood or that they have NOT understood anything.
With the low literacy levels it is most likely that they
have not understood but go ahead to sign the forms anyway because the clinical
trials come with free health care, which most families cannot afford. People
always ask what is in it for me?
One of the ways noted by the researchers was that
participants agree to participate but when they tell them to come back after
one week for follow up they do not show up. Does that mean they did not
understand?
Secondly, the percentage of participants that drops out of
the research is so small at less than 10% in comparison to an average of 30-40
percent in the developed world.
The lack of independence for the participants to drop out of
clinical trials was attributed to fear, intimidation but researchers were
advised to assure them that they would get the same quality of services as
dropouts.
Researches were reminded by Prof. Florence Mirembe to use
innovative approaches to informed consent using the simplest language, flip
charts, videos, explaining the procedure, the potential risks and discomforts
as a result of the research.
For instance, drawing of blood may result into fainting,
this does not have an equivalent word in the local languages but it should be
explained thoroughly.
The poor bear the burden of clinical trials and they should
be protected from exploitation to gain from the products of the research.
With the number of clinical trials increasing in Uganda, so
are ‘safari’ research and the increasing lack of understanding of informed
consent among communities.
I have only written about one site
http://healthdev.net/site/post.php?s=8014 where participants were given
pre-service tests that they had to pass before undergoing male circumcision. If
more protection and understanding is not done for participating communities in
clinical trials the scale will be topping more towards exploitation.
Ends-