PMID- 28317002 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20191120 IS - 2329-4515 (Print) IS - 2329-4523 (Electronic) IS - 2329-4515 (Linking) VI - 6 IP - 4 DP - 2015 TI - Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial. PG - 31-43 LID - 10.1080/23294515.2015.1015184 [doi] AB - 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. FAU - Chapman, Kimberley N AU - Chapman KN AD - Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and CDC Foundation. FAU - Pevzner, Eric AU - Pevzner E AD - Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. FAU - Mangan, Joan M AU - Mangan JM AD - Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. FAU - Breese, Peter AU - Breese P AD - Denver Public Health and University of Colorado Health Sciences Center. FAU - Lamunu, Dorcas AU - Lamunu D AD - Uganda-Case Western Reserve University Research Collaboration. FAU - Shrestha-Kuwahara, Robin AU - Shrestha-Kuwahara R AD - Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. FAU - Nakibali, Joseph G AU - Nakibali JG AD - Uganda-Case Western Reserve University Research Collaboration and Community Research Advisory Group, Tuberculosis Trials Consortium. FAU - Goldberg, Stefan V AU - Goldberg SV AD - Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and Tuberculosis Trials Consortium (TBTC). LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Journal Article DEP - 20150219 PL - United States TA - AJOB Empir Bioeth JT - AJOB empirical bioethics JID - 101631047 PMC - PMC5351885 MID - NIHMS823404 OTO - NOTNLM OT - Comprehension OT - informed consent OT - satisfaction OT - tuberculosis COIS- CONFLICTS OF INTEREST Kimberley N. Chapman is employed by the CDC Foundation. EDAT- 2015/01/01 00:00 MHDA- 2015/01/01 00:01 PMCR- 2017/03/15 CRDT- 2017/03/21 06:00 PHST- 2017/03/21 06:00 [entrez] PHST- 2015/01/01 00:00 [pubmed] PHST- 2015/01/01 00:01 [medline] PHST- 2017/03/15 00:00 [pmc-release] AID - 10.1080/23294515.2015.1015184 [doi] PST - ppublish SO - AJOB Empir Bioeth. 2015;6(4):31-43. doi: 10.1080/23294515.2015.1015184. Epub 2015 Feb 19.