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Self-directed multimedia process for delivering participant informed consent


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Chapman, N, McWhirter, R ORCID: 0000-0002-9409-8074, Armstrong, MK ORCID: 0000-0002-3948-2452, Fonseca, R ORCID: 0000-0003-4480-2542, Campbell, JA ORCID: 0000-0002-1820-6758, Nelson, M ORCID: 0000-0001-9941-7161, Schultz, MG ORCID: 0000-0003-3458-1811 and Sharman, JE ORCID: 0000-0003-2792-0811 2020 , 'Self-directed multimedia process for delivering participant informed consent' , BMJ Open, vol. 10, no. 7 , pp. 1-7 , doi: 10.1136/bmjopen-2020-036977.

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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)

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