Abstract:
Background: A signed informed consent (IC) form proves voluntary participation in a study.
Yet the development of accessible and understandable IC forms comes with its own set of
challenges, particularly when conducting international research. Purpose: This study explores
understanding by participants in an Eldoret-based clinical trial of IC and its implications as
well as whether they will volunteer for future trials. Materials and Methods: In mid-2010,
in-depth interviews with trial participants were recorded in audio format. Content analysis
provides a description of trial participants’ experiences and thoughts. Results: All participants
were informed about the trial and its voluntariness and they consented. However, some were
too ill to scrutinize trial details. Thus, they relied on their health care provider’s advice, or on
their guardians. In general, participants understood their role and were happy to volunteer or
invite others to participate in future trials. They also emphasised the importance of an open
on-going dialogue in order for participants to be able to ask questions. Conclusion: Clinical
trial participants in Eldoret seem to understand their role, but rely on providers and guardians
when consenting. They are very willing to participate in future trials. Evaluation of research
participants’ opinions may improve trial protocols, increase comprehension and guard against
manipulation of study participants. In addition, this research focus should guide development
of consent forms and process that facilitates a truly IC.
