Kimberley N Chapman1, Eric Pevzner2, Joan M Mangan2, Peter Breese3, Dorcas Lamunu4, Robin Shrestha-Kuwahara2, Joseph G Nakibali5, Stefan V Goldberg6. 1. Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and CDC Foundation. 2. Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. 3. Denver Public Health and University of Colorado Health Sciences Center. 4. Uganda-Case Western Reserve University Research Collaboration. 5. Uganda-Case Western Reserve University Research Collaboration and Community Research Advisory Group, Tuberculosis Trials Consortium. 6. Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and Tuberculosis Trials Consortium (TBTC).
Abstract
BACKGROUND: Ethical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. METHODS: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. RESULTS: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24-42). Median ICAT scores were 80% (IQR: 67-93) for comprehension and 89% (IQR: 78-100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. CONCLUSIONS: Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.
BACKGROUND: Ethical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. METHODS: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. RESULTS: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24-42). Median ICAT scores were 80% (IQR: 67-93) for comprehension and 89% (IQR: 78-100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. CONCLUSIONS:Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.
Authors: Allison E Crepeau; Bart I McKinney; Maya Fox-Ryvicker; Jennifer Castelli; James Penna; Edward D Wang Journal: J Bone Joint Surg Am Date: 2011-10-05 Impact factor: 5.284
Authors: Laurie Sandman; Ann Mosher; Awal Khan; Jan Tapy; Rany Condos; Scott Ferrell; Andrew Vernon Journal: Contemp Clin Trials Date: 2006-07-28 Impact factor: 2.226
Authors: Ronald Kiguba; Paul Kutyabami; Stephen Kiwuwa; Elly Katabira; Nelson K Sewankambo Journal: BMC Med Ethics Date: 2012-08-21 Impact factor: 2.652
Authors: Adam Nishimura; Jantey Carey; Patricia J Erwin; Jon C Tilburt; M Hassan Murad; Jennifer B McCormick Journal: BMC Med Ethics Date: 2013-07-23 Impact factor: 2.652