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; Kai Wang; Laura A Shinkunas; Daniel T Stein; Paul Meissner; Maureen Smith; Rebecca Pentz; David W Klein

doi:10.1177/15562646211038819

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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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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, Kai Wang, Laura A Shinkunas, Daniel T Stein, Paul Meissner, Maureen Smith, Rebecca Pentz and David W Klein

Journal of empirical research on human research ethics, Vol.17(1-2), pp.144-166

02/2022

DOI: 10.1177/15562646211038819

PMCID: PMC8712348

PMID: 34410195

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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.

Details

Title: Subtitle: Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes
Creators: Christian M Simon - Duke University, Durham, NC, USA
Kai Wang - University of Iowa, Iowa City, IA, USA
Laura A Shinkunas - University of Iowa, Iowa City, IA, USA
Daniel T Stein - Albert Einstein College of Medicine, Bronx, NY, USA
Paul Meissner - Albert Einstein College of Medicine, Bronx, NY, USA
Maureen Smith - Northwestern University, Chicago, IL, USA
Rebecca Pentz - School of Medicine, Emory University, Atlanta, GA, USA
David W Klein - University of Iowa, Iowa City, IA, USA
Resource Type: Journal article
Publication Details: Journal of empirical research on human research ethics, Vol.17(1-2), pp.144-166
DOI: 10.1177/15562646211038819
PMID: 34410195
PMCID: PMC8712348
NLM abbreviation: J Empir Res Hum Res Ethics
ISSN: 1556-2646
eISSN: 1556-2654
Grant note: DOI: 10.13039/100000051, name: National Human Genome Research Institute, award: R01HG008348
Language: English
Date published: 02/2022
Academic Unit: Medical Ethics; Law, Health Policy and Disability Center; Biostatistics; Internal Medicine
Record Identifier: 9984213374102771

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