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.
| Horng, Sam; Emanuel, Ezekiel J; Wilfond, Benjamin et al. (2002) Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 347:2134-40 |
