An assessment of individuals' understanding of informed consents in clinical trials

This study examined individual's understanding of informed consents in clinical trials. This research assessed whether an individual understood the risks of entering a clinical trial, their understanding of whether the study medication has been approved by the Food and Drug Administration (FDA), and if they felt they were guaranteed to benefit from receiving the study medication.; In order to obtain this information, twenty-five male individuals were randomly asked to complete an Informed Consent Questionnaire after reading an informed consent related to a prostate cancer study, and the results were then compiled and analyzed.; The results support the research hypothesis of the study about uninformed participants. Results demonstrate that individuals do not have a complete understanding of the informed consent forms they read. These findings suggest that subjects do not always achieve fully informed consent prior to participating in a clinical trial which supports the use of multiple approaches to assure subjects understand all the information contained in an informed consent form. (Abstract shortened by UMI.)...