Informed consent and research subject understanding of clinical trials.

CONTEXT Current evidence suggests many clinical trial participants have incomplete understanding of research objectives and methods. OBJECTIVE Determine consent standards compliance, satisfaction with facility and study staff, and research subject understanding of clinical trials. DESIGN Retrospective review of responses gathered when subjects were interviewed at the inception of clinical trial participation. SETTING Clinical research unit at the University of Wisconsin, Madison. PATIENTS Clinical trials participants on the research unit. MAIN OUTCOME MEASURES Understanding of the particular trial in which each subject was participating; research team compliance with informed consent standards; and satisfaction with the research facility, staff, and clinical trials teams. RESULTS 423 of 570 research participants were oncology patients; 298 were males. Age range was 10 to 90 years old (mean of 56.6 (+/- 16.6) years old). Most subjects (99%) had signed the consent form; 97% reported satisfaction with the research facility and 96% with the study staff. Four-fifths of participants had accurate knowledge of study aims, methods, and risks, but 20% of subjects understood considerably less. Oncology subjects were older (mean age 60.1 [+/- 12.5] years vs 46.4 [+/- 21.9] years, P < 0.001). Non-oncology subjects and patients under age 61 demonstrated superior study knowledge (P < 0.001). CONCLUSION Compliance with informed consent standards and satisfaction with services and staff was excellent. Future efforts should focus on better informing older subjects and those on oncology trials.