Two Methods of Obtaining Informed Consent in a Genetic Epidemiological Study: Effects on Understanding

THIS STUDY EVALUATED THE EFFECT ON participant understanding and participation rates of two different approaches to obtaining informed consent, using 2,192 actual research subjects in a genetic cohort study. One group received the routine approach consisting of written materials and an oral explanation. The other group received a more intense approach consisting of educational lectures and group meetings in addition to the routine approach. Subjects in the intense approach group were relatively more likely to read some or all of the explanatory material. Those in the intense group who did not read the material were more likely than those in the routine group to express uncertainty about their understanding of the research. Those in the intense group who read the material perceived that they had a higher level of understanding of the research and this was associated with a higher frequency of volunteering to participate. In contrast, subjects in the routine group were less likely to read the written material, but ironically more likely to assume that they understood what the research was about. These rather paradoxical findings raised questions about what motivates potential research subjects to become sufficiently engaged to seek actual understanding of the research before volunteering.