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Self-directed multimedia process for delivering participant informed consent

Citation

Chapman, N and McWhirter, R and Armstrong, MK and Fonseca, R and Campbell, JA and Nelson, M and Schultz, MG and Sharman, JE, Self-directed multimedia process for delivering participant informed consent, BMJ Open, 10, (7) Article e036977. ISSN 2044-6055 (2020) [Refereed Article]


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© 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/

DOI: doi:10.1136/bmjopen-2020-036977

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<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).

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 Details

Item Type:Refereed Article
Keywords:blood pressure, hypertension, public health
Research Division:Biomedical and Clinical Sciences
Research Group:Cardiovascular medicine and haematology
Research Field:Cardiology (incl. cardiovascular diseases)
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Chapman, N (Miss Niamh Chapman)
UTAS Author:McWhirter, R (Dr Rebekah McWhirter)
UTAS Author:Armstrong, MK (Mr Matthew Armstrong)
UTAS Author:Fonseca, R (Mr Ricardo Fonseca Diaz)
UTAS Author:Campbell, JA (Dr Julie Campbell)
UTAS Author:Nelson, M (Professor Mark Nelson)
UTAS Author:Schultz, MG (Dr Martin Schultz)
UTAS Author:Sharman, JE (Professor James Sharman)
ID Code:140110
Year Published:2020
Deposited By:Menzies Institute for Medical Research
Deposited On:2020-07-27
Last Modified:2020-08-07
Downloads:5 View Download Statistics

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