Self-directed multimedia process for delivering participant informed 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.
Funding
Royal Hobart Hospital Research Foundation
History
Publication title
BMJ OpenVolume
10Issue
7Article number
036977Number
036977Pagination
1-7ISSN
2044-6055Department/School
Menzies Institute for Medical ResearchPublisher
BMJ GroupPlace of publication
United KingdomRights statement
© 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/Repository Status
- Open