Promises Of Benefit Phase I Oncology Informed Consent Fo

本协议将分析I期肿瘤学试验的同意书，以评估其性质、风险和潜在益处的沟通方式。I期同意书是从所有nci指定的综合癌症中心和进行I期肿瘤试验的主要制药公司收集的。一期肿瘤临床试验在伦理上存在争议，因为它们通常涉及绝症患者，几乎没有提供直接益处的前景。采访一期癌症受试者的研究表明，他们中的许多人希望从这些试验中受益。为了评估研究目的的描述和对直接获益的承诺是如何传达给受试者的，我们审查了来自80%的NCI指定癌症中心和前10名癌症制药商中的6家的1999年所有I期肿瘤学同意书。使用评分工具，我们评估了同意书中的5个领域：1)试验特征，2)研究目的和程序，3)益处，4)风险和5)替代方案。我们发现总体而言，I期肿瘤学同意书没有过度承诺获益或低估风险。事实上，272份表格中只有1份表示参与者可以预期获益，而且大多数都将获益的前景描述为不确定。绝大多数人描述了第一阶段试验的目的，并全面排除了风险，包括提到死亡的可能性。

This protocol will analyze consent forms for Phase I oncology trials to assess the manner in which the nature, risks, and potential benefits are communicated. Phase I consent forms were collected from all of the NCI-designated comprehensive cancer centers and from major pharmaceutical companies that conduct Phase I oncology trials. Phase I oncology clinical trials are ethically controversial because they typically involve terminally ill patient-subjects and offer almost no prospect of direct benefit. Studies interviewing Phase I cancer subjects show that many of them expect to benefit from these trials. To evaluate how the description of research purpose and the promise of direct benefit is communicated to subjects, we reviewed all 1999 Phase I oncology consent froms from 80% of the NCI designated cancer centers and from 6 of the top 10 cancer pharmaceutical manufacturers. With a scoring instrument, we evaluated 5 domains in the consent forms: 1) characteristics of the trial, 2) the research purpose and procedures, 3) benefits, 4) risks and 5) alternatives. We found that overall the Phase I Oncology consent forms did not overpromise benefit or downplay risk. In fact, only 1 of 272 forms said the participant could expect benefit, and most described the prospect of benefit as uncertain. The vast majority described the purpose of the Phase I Trial and dismissed risk comprehensively, including mentioning the possibility of death.