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.