I am involved in vaccine trials in Gambia, West Africa where informed consent process poses several logistic and ethical challenges. In the Gambia, the informed consent process poses a more peculiar challenge as all major languages do not have standard orthographic writing system making translation of informed consent into local languages very difficult and sometimes impractical and this creates the need for a more objective assessment of the understanding of the information provided during the informed consent process within the research environment.
I think such understanding may inform the development of a tool that will aid study participants’ understanding of the information provided and help protect their human rights. I do not know what your experiences have been in your various sites about this and what strategies/tools you are using.
I was involved in two major clinical trials that used informed consents (CF), both studies were performed in low income populations and also vulnerable populations as are men that have sex with other men. I one study, international settings were established in Asia, Africa and South-America and the isue of CF standards was quite difficult at the beggining, specially with the type of populations we were working with. Main issues were: (i) understanding of the self-consent process by the entire populations and sub-populations, specially those non-well literated, (ii) design of the adequate formate to make it less extensive, understandable, easy to follow and informative, (iii)allow local cultural issues since it was applied in different countries and contexts.
Solutions came up withy meetings regarding the phrases to be used, contain of the document, local legal issues to deal with, literacy of the population and in cases were no literacy how to manage it through interviewers, training of the interviewers and CI applicants.
When we agree a final CF version, we tested it and prepare a Exit Interview where we asked for the easyness of the application of the instrument itself, how much information people keeps from the CI, understanding of the rights and duties written in the consent.
One important thing when working with people in LRS us that they always collaborate and are able to learn, so using computers and hanhelds or else sometimes can held to make easier the understanding and application of CF.