Abstract

Cancer chemoprevention trials test the efficacy of pharmaceutical agents in preventing cancer in at-risk research subjects who are neither patients diagnosed with the disease nor typical healthy volunteers. Such trials present unique challenges to investigators and IRB reviewers when evaluating risks and benefits, assessing informed consent, and compensating subjects. Investigators and IRBs should pay particular attention to the criteria used to define at-risk subjects and carefully assess the strength of the evidence supporting them, as this is critical to evaluating the risk-benefit ratio