A randomized controlled trial of an electronic informed consent process

Journal of Empirical Research on Human Research Ethics : JERHRE
Erin RothwellJeffrey R Botkin

Abstract

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.

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Citations

Mar 2, 2017·The New England Journal of Medicine·Christine GradyGagandeep Kang
Mar 12, 2016·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Tamar Krishnamurti, Nichole Argo
May 24, 2018·Journal of Empirical Research on Human Research Ethics : JERHRE·Christian M SimonDavid W Klein
Sep 3, 2016·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Harriet A Washington
Nov 7, 2017·Informatics for Health & Social Care·Christiana McMahon, Spiros Denaxas
Jul 18, 2019·Paediatric Drugs·Susan M Abdel-Rahman
Oct 28, 2017·Journal of Empirical Research on Human Research Ethics : JERHRE·Erin RothwellJeffrey R Botkin
Oct 9, 2020·Journal of Medical Internet Research·Evelien De SutterIsabelle Huys
Nov 28, 2020·Journal of Clinical and Translational Science·Colleen E LawrencePaul A Harris
May 15, 2018·Journal of Obstetric, Gynecologic, and Neonatal Nursing : JOGNN·Julia C PhillippiChristianne L Roumie
Aug 23, 2021·BMC Medical Research Methodology·Sina KianersiMolly Rosenberg
Feb 26, 2019·Neonatology·Annie JanvierUNKNOWN on behalf of the Partenariat Famille (PAF) team
Dec 16, 2021·Revista da Associação Médica Brasileira·Juliana Carvalho Rocha Alves da Silva, Helaine Carneiro Capucho

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