Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...) do not necessarily invalidate consent by phase 1 trial participants. (shrink)

Purpose Recent research has found unrealistic optimism among patient-subjects in early-phase oncology trials. Our aim was to investigate the cognitive and motivational factors that evoke this bias in this context. We expected perceptions of control to be a strong correlate of unrealistic optimism. Methods A study of patient-subjects enrolled in early-phase oncology trials was conducted at two sites in the USA. Respondents completed questionnaires designed to assess unrealistic optimism and several risk attribute variables that have been found to evoke the (...) bias in other contexts. Results One hundred and seventy-one patient-subjects agreed to be interviewed for our study. Significant levels of perceived controllability were found with respect to all nine research-related questions. Perceptions of control were found to predict unrealistic optimism. Two other risk attribute variables, awareness of indicators and mental image, were correlated with unrealistic optimism. However, in multivariate regression analysis, awareness and mental image dropped out of the model and perceived controllability was the only factor independently associated with unrealistic optimism. Conclusion Patient-subjects reported that they can, at least partially, control the benefits they receive from participating in an early-phase oncology trial. This sense of control may underlie unrealistic optimism about benefiting personally from trial participation. Effective interventions to counteract unrealistic optimism may need to address the psychological factors that give rise to distorted risk/benefit processing. (shrink)

Bioethicists often draw sharp distinctions between hope and states like denial, self-deception, and unrealistic optimism. But what, exactly, is the difference between hope and its more suspect cousins? One common way of drawing the distinction focuses on accuracy of belief about the desired outcome: Hope, though perhaps sometimes misplaced, does not involve inaccuracy in the way that these other states do. Because inaccurate beliefs are thought to compromise informed decision making, bioethicists have considered these states to be ones where intervention (...) is needed either to correct the person’s mental state or to persuade the person to behave differently, or even to deny the person certain options. In this article, we argue that it is difficult to determine whether a patient is really in denial, self-deceived, or unrealistically optimistic. Moreover, even when we are confident that beliefs are unrealistic, they are not always as harmful as critics contend. As a result, we need to be more permissive in our approach to patients who we believe are unrealistically optimistic, in denial, or self-deceived—that is, unless patients significantly misunderstand their situation and thus make decisions that are clearly bad for them, we should not intervene by trying to change their mental states or persuade them to behave differently, or by paternalistically denying them certain options. (shrink)

자국의 통상이익을 확보하려는 국가의 노력과 무역의 자유화와 확대를 위한 경제심 판관으로서 WTO의 역할은 인류복지의 극대화를 위하여 한 방향으로 나아가면서도 충 돌하고 있다. 개별국가의 성장과 복지없는 인류복지의 극대화는 껍데기에 불과하고, 자유와 비차별(non-discrimination)의 원칙에 바탕한 기회균등, 공정경쟁조건의 보장이 없는 한 국제무역은 홉즈식 "즉발적 利己主義(spontaneous disorder)"만이 횡행하게 된 다. 이를 구제하기 위하여 국가적·국제적 통상관리체제가 발전되어 왔으며, WTO가 세 계경제헌법체제로서 많은 역할을 하고 있는 것은 주지의 사실이다. 많은 WTO업적 중 최근의 버드법 문제는 그 이례성과 전략성으로 인하여 양식있는 자의 관심이 대상이 되어 왔으며, 최근 미 (...) 연방법원과 WTO분쟁해결기구는 동 법의 적립금배분조항에 관 하여 국제적·국내적으로 위헌성을 확인한 바 있다. 그러나 양대 司法機關의 결정취지는 동일한 것이 아니다. 미국 연방법원은 문제된 버드법 조항이 헌법상 보장된 표현의 자 유와 평등권을 침해하여 위헌이라는 결정을 하였고, WTO분쟁해결기구는 반덤핑협정 이나 보조금협정 등 관련협정에서 허용하고 있지 않는 내용의 무역규제조치를 하였다 는 이유로 동법의 협정위반을 선언하고 그 철폐를 권고하였다. 이에 본고는 버드법상 적립금배분제도에 관한 양대 사법기관의 결정요지를 살펴보고, 헌법국가의 이상이라는 관점에서 사법기관의 역할과 버드법에 관한 사법심사가 주는 시사점을 음미하기로 한 다. 이는 종래의 외교통상문제와 국내문제의 엄별이라는 기존관념으로부터 헌법국가이 상의 역사적 의의와 발전, 국제법과 국내법의 관계, 사법기관의 국제적 협조와 연대라 는 관점에서 보다 적극적 자세로의 인식전환과 관련을 갖는다. 사법기관은 역사적으로 시민사회의 형성ㆍ발전에 있어 기본적 가치의 수호를 통하여 국제적ㆍ국내적 차원에서 중요한 역할을 하여 왔으나,현대 국제사회에서는 외교통상 행정영역의 발전에 뒤떨어 지는경향이있고, 세계헌법주의라는 관점에서 새로운 조명이 필요하다고 본다. 결론에 서는 현재 국제사회의 현실에서 사법부를 포함하여 우리정부의 전략적ㆍ법제적 대응 방안을 간략히 적시해 보도록 한다. (shrink)

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participating in a clinical trial. In order to test for the prevalence of unrealistic optimism among participants of early-phase oncology trials, we (...) conducted a survey with patients over 18 years of age who were enrolled in a phase I, phase I/II, or phase II clinical cancer trial in the New York City area between August 2008 and October 2009. Participants in our study were asked to compare their own chances of experiencing a range of risks and benefits related to the trial they were enrolled in with the chances of the other trial participants. We found a significant optimistic bias in their responses. Respondents tended to overestimate the benefits of the trial they were enrolled in and underestimate its risks. In addition, we found no significant relationship between respondents’ understanding of the trial’s purpose and how susceptible they were to unrealistic optimism. Our findings suggest that improving the consent process for oncology studies requires more than addressing deficits in understanding. (shrink)