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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 144-166 |
| Number of pages | 23 |
| Journal | Journal of Empirical Research on Human Research Ethics |
| Volume | 17 |
| Issue number | 1-2 |
| DOIs | |
| State | Published - Feb 2022 |
Funding
The authors want in particular to express deep appreciation for Dr. Helen A. Schartz, who passed away prior to this publication. Dr. Schartz, Director of Research at the Law, Health Policy & Disability Center, College of Law, The University of Iowa, has been a collaborator with us for over a decade of research on the topic of multimedia IC for research. Together we have conducted pilot studies and follow-up research projects that directly led to the study described here. Her contributions to this research included input on the theoretical model, constructs used in understanding and analyzing data, and the design of the studies. She assisted in organizing and managing our projects and was involved in the statistical analyses of prior studies, as well as provided input in the analysis of the current study. She was also coauthor of additional articles in recent years also relating to multimedia IC (Simon et al., 2014, 2015, 2018). For the current study, Dr. Schartz as a coprincipal investigator was involved in the writing of the proposal, including input into the literature review, design of the study, decisions about which sites to collaborate with, decisions about which variables we used to collect data, and the concomitant design of the instruments. During the study, she oversaw the budget, was involved in communicating with our external collaborators, and had input in the day-to-day operations of data collection. Dr. Schartz had the background and intelligence to do great research. Her wise and practical advice kept this project focused and on budget. She was the force that made the research successful. We are indebted to her skills, insight, and leadership during our time with her. She is greatly missed. The authors would also like to thank Margie Dixon, Syreese Fuller, Mary Catherine Thomson, and Melissa Haban at Emory University; Angelica Espinoza, Tress Keogh, Tina Ward, and Sharon Aufox at Northwestern University; Sally Duran, Abel Infante, Lizbeth Gomez, and Harly Rodriguez at Albert Einstein College of Medicine; and Joyce Craig at The University of Iowa Program in Bioethics and Humanities. The authors are deeply appreciative of their assistance with and support of this study. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a grant from the National Human Genome Institute at the National Institutes of Health (grant no. R01HG008348). The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a grant from the National Human Genome Institute at the National Institutes of Health (grant no. R01HG008348).
Keywords
- biobanking
- electronic
- informed consent
- interactive
- multimedia
ASJC Scopus subject areas
- Social Psychology
- Education
- Communication
- Law