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Abstract

Objective: Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent. Design: It is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent. Setting: Pathology blood collection services in Tasmania, Australia. Participants: 298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152). Outcome measures: Efficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire. Results: All participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p Conclusion: A self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.

Item Type:	Article
Authors/Creators:	Chapman, N and McWhirter, R and Armstrong, MK and Fonseca, R and Campbell, JA and Nelson, M and Schultz, MG and Sharman, JE
Keywords:	blood pressure, hypertension, public health
Journal or Publication Title:	BMJ Open
Publisher:	BMJ Group
ISSN:	2044-6055
DOI / ID Number:	10.1136/bmjopen-2020-036977
Copyright Information:	© Author(s) (or their employer(s)) 2020. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
Related URLs:	Google Scholar: McWhirter, R UTAS Profile: McWhirter, R Google Scholar: Fonseca, R Google Scholar: Nelson, M UTAS Profile: Nelson, M Google Scholar: Schultz, MG UTAS Profile: Schultz, MG Google Scholar: Sharman, JE UTAS Profile: Sharman, JE
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