• IRB: ETHICS & HUMAN RESEARCH

The Impact of Unrealistic Optimism on Informed Consent in Early-Phase Oncology Trials

Social psychological research has demonstrated that people are often unrealistically optimistic about their chances of experiencing future positive and negative outcomes. Past research has found significant levels of this bias among participants in early-phase oncology trials. Our aim was to investigate how unrealistic optimism relates to several key elements of informed consent. A multicenter study of patient-subjects enrolled in early phase oncology trials was conducted at two sites in the United States. Respondents completed questionnaires designed to assess unrealistic optimism, understanding of the purpose of the trial, appreciation of research-related information, and perceived voluntariness. One hundred and seventy-one patient-subjects were interviewed. Significant levels of unrealistic optimism were found for eight out of nine items. Unrealistic optimism was found to be negatively associated with subjects’ appreciation of their role in the study. Unrealistic optimism was also found to be negatively associated with subjects’ appreciation of the associated risks and benefits. There was no significant association between the bias and subjects’ understanding of the purpose of the trial in which they were enrolled (p = 0.54) or their perceived ability to decline trial participation (p = 0.91). Unrealistic optimism is prevalent among patient-subjects enrolled in early-phase oncology trials and is significantly associated with lack of appreciation of research-related risk-benefit information.

Keywords: unrealistic optimism, informed consent, early-phase oncology trials, risks and benefits of research