University Of Tasmania
140110 - Self-directed multimedia process for delivering participant informed consent.pdf (622.07 kB)

Self-directed multimedia process for delivering participant informed consent

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journal contribution
posted on 2023-05-20, 16:28 authored by Niamh ChapmanNiamh Chapman, Rebekah McWhirterRebekah McWhirter, Matthew Armstrong, Ricardo Fonseca Diaz, Julie CampbellJulie Campbell, Mark NelsonMark Nelson, Martin SchultzMartin Schultz, James SharmanJames Sharman
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.


Royal Hobart Hospital Research Foundation


Publication title

BMJ Open





Article number









Menzies Institute for Medical Research


BMJ Group

Place of publication

United Kingdom

Rights statement

© Author(s) (or their employer(s)) 2020. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)

Repository Status

  • Open

Socio-economic Objectives

Clinical health not elsewhere classified

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