title: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX, USA.
authors.forename: Laeeq
authors.initials: L
authors.lastname: Malik
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center, San Antonio, TX, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Mejia
keywords: Informed consent; Oncology; Patient; Phase I; Trial
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