Taking part in a pharmacogenetic clinical trial:assessment of trial participants understanding of information disclosed during the informed consent process

BACKGROUND: This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication. METHODS: This was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan. RESULTS: Only one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to. CONCLUSION: Participants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment