Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes.

Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes.
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DOI:
10.1177/15562646211038819
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发表时间:
2022-03
期刊:
Journal of empirical research on human research ethics : JERHRE
影响因子:
--
通讯作者:
Klein DW
Klein DW
中科院分区:
其他
文献类型:
--
作者:
Simon CM;Wang K;Shinkunas LA;Stein DT;Meissner P;Smith M;Pentz R;Klein DW

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有些人对知情同意(IC)信息的理解可能会通过电子交付得到改善,但其他人可能会从面对面(F2F)中受益。这项随机的多地点研究探讨了来自不同背景的个人如何理解电子IC文档与F2F,他们对理解的信心以及参与研究的情况。来自美国两个生物库的501名不同人群的患者参与了研究。电子和F2F理解之间没有总体差异,但F2F预测理解和入学的信心更高。民族和较高的教育水平预测较高的理解和信心。研究结果表明,电子同意书可能会导致更好地了解非西班牙裔患者的社会经济地位较高。F2F过程可能会导致更好的理解和更高的西班牙裔和较低社会经济水平的患者入组。研究人员应仔细考虑如何实施电子IC流程,以及是否维持F2F流程,以更好地满足某些人群的需求和局限性。
Some individuals’ understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.
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