A randomized controlled trial of an electronic informed consent process.
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.
University of Utah, Salt Lake City, USA erin.rothwell@nurs.utah.edu.
Erin
E
Rothwell
University of Utah, Salt Lake City, USA.
Bob
B
Wong
University of Utah, Salt Lake City, USA Intermountain Healthcare, Salt Lake City, UT, USA.
Nancy C
NC
Rose
University of Utah, Salt Lake City, USA.
Rebecca
R
Anderson
Intermountain Healthcare, Salt Lake City, UT, USA.
Beth
B
Fedor
University of Utah, Salt Lake City, USA.
Louisa A
LA
Stark
University of Utah, Salt Lake City, USA.
Jeffrey R
JR
Botkin
D001296:Audiovisual Aids; D032882:Comprehension; D032962:Consent Forms; D004581:Electronics; D006801:Humans; D007258:Informed Consent; D010209:Paper; D012106:Research; D035842:Research Subjects; D011795:Surveys and Questionnaires
electronic; informed consent; randomized controlled trials