A Consent Form Template for Phase I Oncology Trials‪.‬

The two primary components of the consent process A for research are a consent form and a discussion between the investigator and the potential research participant. Although empirical assessments of consent forms suggest that the majority contain an adequate description of the risks and benefits associated with participating in a given study, important deficiencies remain. Consent forms are characterized by excessive length, a lack of organization, and complex language that is tailored to an above-average reading level and is often confusing--or, worse, misleading-to many readers. (1) For instance, one study of phase I consent forms found that their average length was 6.4 pages (with a range of 3 to 13 pages) and that 96% of them referred to the investigational agent as "treatment" or "therapy" without including modifying words such as "experimental" or "research." (2) Some commentators have alleged that overall, consent forms may do more harm than good by obfuscating the information relayed in the physician consultation. (3) Several attempts have been made to simplify consent forms, (4) and the National Cancer Institute (NCI) has developed guidelines for improving these documents, as well as a template to help investigators and institutional review boards (IRBs) draft and review them. (5) However, the NCI template aims to be comprehensive and is not specific to phase I trials. Because cancer patients often fail to understand that there is only a small chance of therapeutic benefit from phase I trials, concerns have been raised about whether they can provide fully informed consent to participate. (6) We believe that a simple, clear consent form is an important component of improving the informed consent process for phase I oncology trials and have therefore developed a shorter, simplified consent form template specific to phase I oncology trials.