Descriptions of benefits and risks in consent forms for phase 1 oncology trials.

Background: Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks.

Methods: To evaluate the written description of direct benefit as well as risk, all consent forms for 1999 phase 1 cancer trials were compiled from 80 percent of the National Cancer Institute-designated cancer centers and from six of eight large pharmaceutical developers of anticancer drugs. In each case, we evaluated the characteristics of the trial, the descriptions of the purpose and procedures of the research, the promise of benefit, the description of risks, and the description of alternatives.