Informed Consent for Phase I Oncology Trials: Form, Substance and Signature

Abstract

BACKGROUND: Federal regulations state consent information should be understandable to participants; concerns have been voiced about the quality of informed consent forms (ICFs) in oncology trials.METHODS: The content of ICFs for phase I studies that were conducted at a tertiary care cancer center over 3 years' period was reviewed. Information pertaining to the length of the ICF, description of study purpose, research regimen/methods, treatment agent, potential risks, benefits and alternatives to the research was extracted.RESULTS: In total, 54 ICFs for phase I trials approved by the local Institutional Review Board were reviewed. Median length of ICF was 20 pages. Nearly one half of the forms (57.4%) were of first-in-human phase I studies. The main goal of research was explicitly stated as safety testing in 59.2% forms, while 37.1% studies described primary objective as dose finding. All of the forms identified serious risks, unexpected risks, possibility of death and risks to pregnant and or lactating women. A detailed estimation of the frequency or intensity of risks (range 3-8 pages) was provided qualitatively or quantitatively if known. Information regarding mechanism of action of investigational agent, study schema, dose escalation, loss of time/energy and possibility of receiving sub-therapeutic dose was missing in significant number of forms.CONCLUSION: We found that these ICFs were compliant with approved guidelines and provided a thorough description of risks or potential benefits. However, there still remains room for improvement, so patients can make better informed decisions.