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. 2022 Feb-Apr;17(1-2):144-166.
doi: 10.1177/15562646211038819. Epub 2021 Aug 19.

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

Christian M Simon  1 , Kai Wang  2 , Laura A Shinkunas  2 , Daniel T Stein  3 , Paul Meissner  3 , Maureen Smith  4 , Rebecca Pentz  5 , David W Klein  2
Affiliations

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

Christian M Simon et al. J Empir Res Hum Res Ethics. 2022 Feb-Apr.

Abstract

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.

Keywords: biobanking; electronic; informed consent; interactive; multimedia.

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Figures

Figure 1.
Figure 1.
Study procedure within site biobank consent process.
Figure 2.
Figure 2.
Sample electronic informed consent (eIC) screen using exact wording from the biobank consent document with added graphics.
Figure 3.
Figure 3.
Box plot comparison of mean understanding scores for the group by condition (electronic informed consent [eIC] vs. face-to-face [F2F]).
Figure 4.
Figure 4.
Box plot comparison of mean confidence in understanding scores for the group by condition (electronic informed consent [eIC] vs. face-to-face [F2F]).
See this image and copyright information in PMC

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