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.
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.
Authors: Nimali Jayasinghe; B Isabel Moallem; Margo Kakoullis; Mary-Jane Ojie; Lili Sar-Graycar; Katarzyna Wyka; M Cary Reid; John P Leonard Journal: Gerontologist Date: 2019-01-09
Authors: Francis Anyaka Amayoa; Frederick Nelson Nakwagala; John Barugahare; Ian Guyton Munabi; Erisa Sabakaki Mwaka Journal: J Empir Res Hum Res Ethics Date: 2022-05-12 Impact factor: 1.978