Perceptions of informed consent by participants in a prostate cancer prevention study.

This study examined perceptions of the informed consent process in healthy men participating in a cancer prevention clinical trial. Specifically, we examined influence of the consent form on participation and understanding, adequacy of the consent process in preparing participants for trial experiences, and perceived needs for additional follow-up strategies. Participants (n = 69) enrolled in the Prostate Cancer Prevention Trial at our institution completed mailed questionnaires approximately 2 years after joining the study. Results indicated that many participants had no remembrance of the consent process, and only a minority reported that the consent process had helped in decision-making about study participation. Eleven men (16%) reported experiencing unexpected study side effects, most related to sexual functioning. Most men (78%) did not feel that they currently needed more information about the study, although virtually all of the respondents wanted to learn the study results. Almost one-third wished to interact with other Prostate Cancer Prevention Trial participants. Results indicate that a signed consent form and initial counseling for a prevention study does not ensure that participants feel they are adequately informed about the study or the side effects. Providing and reinforcing information on a regular and continuous basis is especially important in studies where compliance is required over a period of years.