Chapman Kimberley N, Pevzner Eric, Mangan Joan M, Breese Peter, Lamunu Dorcas, Shrestha-Kuwahara Robin, Nakibali Joseph G, Goldberg Stefan V
Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and CDC Foundation.
Division of Tuberculosis Elimination, Centers for Disease Control and Prevention.
AJOB Empir Bioeth. 2015;6(4):31-43. doi: 10.1080/23294515.2015.1015184. Epub 2015 Feb 19.
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.
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.
ICATs ( = 54) were submitted from one site in Spain ( = 10), one in Uganda ( = 30), and five in the United States ( = 14). Participants were primarily male (76%), born in Africa ( = 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.
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.
伦理原则要求研究人员在临床试验的知情同意过程中，最大限度地提高研究参与者的理解程度。在一项治疗肺结核的国际临床试验期间，对同意过程进行了初步评估，以评估在更大规模人群中进行评估的可行性，并为未来的工作提供指导。
研究人员向便利抽样的试验参与者发放了一份知情同意评估工具（ICAT），测量对源自《联邦法规汇编》通用规则和美国食品药品监督管理局（FDA）第21编第50部分的同意书内容的理解程度，以及对该过程的满意度。参与研究的各站点工作人员完成了一份关于其各自站点同意程序的问卷，并提出了改进建议。在ICAT分数和相应程序均已完成的情况下，对二者进行了比较。
ICAT问卷（n = 54）分别来自西班牙的一个站点（n = 10）、乌干达的一个站点（n = 30）和美国的五个站点（n = 14）。参与者主要为男性（76%），出生于非洲（n = 31，57%），年龄中位数为27岁（四分位间距[IQR]：24 - 42）。ICAT理解程度分数中位数为80%（IQR：67 - 93），满意度分数中位数为89%（IQR：78 - 100）。乌干达参与者在理解程度（87%对64%）和满意度（100%对78%）方面的得分高于其他站点的参与者。14个站点的工作人员完成了同意程序问卷。在使用视觉辅助工具的站点，ICAT理解程度和满意度分数中位数更高。实践建议包括采用更简短的表格、更简单的文件和补充材料。
参与者对当前的同意程序理解程度和满意度较高（≥80%）。一个站点较高的ICAT分数表明，进一步评估可能会确定在未来试验中提高理解程度和满意度的方法。通过本次初步评估，在一项大型国际多中心试验中获取同意书的过程中发现了复杂性和挑战，并为未来试验中更全面地评估同意程序提供了见解。
