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 are being sought from all of the NCI-designated comprehensive cancer centers and from major pharmaceutical companies that conduct Phase I oncology trials. Institutions have been contacted by phone and are sending consent forms. Data gathering is just beginning. 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 compiled 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) descriptive properties of the trial, 2) the research purpose and procedures, 3) the promise of benefit, 4) risks and 5) alternatives. We have completed the scoring of the consent forms and are performing a statistical analysis on the data. Preliminary results indicate that no consent forms promised direct benefits to subjects. Many forms (87%) qualified the prospect of benefit as uncertain, and almost all forms discuss risk comprehensively, including a mention of death (70%). Finally, nearly all forms (90%) state that the purpose of the trial is to test safety.
| 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 |
