Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research.
Electronic consent
Multimedia
Parental consent
Public health research
User experience
Journal
BMC medical ethics
ISSN: 1472-6939
Titre abrégé: BMC Med Ethics
Pays: England
ID NLM: 101088680
Informations de publication
Date de publication:
08 11 2023
08 11 2023
Historique:
received:
15
12
2022
accepted:
18
10
2023
medline:
10
11
2023
pubmed:
9
11
2023
entrez:
8
11
2023
Statut:
epublish
Résumé
Informed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research. In a sample of parents with young children, we used a mixed method approach to study the user experience of an informed consent app and evaluate whether it can be used to adequately inform people and register their consent. Through semi-structured interviews we investigated participants' experiences with and opinions about the app, with a special focus on comprehensibility of the content and the usability of the app. Information retention questions were asked to evaluate to what extent participants could recall key aspects of the provided study information. The 30 participants in this study used the app between 4 and 15 min to give their consent. Overall, they found the app well-designed, informative and easy to use. To learn more about the study for which informed consent is asked, most of the participants chose to watch the animated film, which was generally found to convey information in a clear manner. The identification process was met with mixed reactions, with some feeling it as a secure way to give consent, while for others it contradicted their view of using data anonymously. Information retention questions showed that while all participants remembered various aspects of the study, fewer than half answered all four questions satisfactorily. Our study shows that a well-designed informed consent app can be an effective tool to inform eligible participants and to record consents. Still, some issues remain, including trust barriers towards the identification procedure and lack of information retention in some participants. When implementing consent procedures that incorporate digital formats, it may be beneficial to also invest in a complementary face-to-face recruitment approach.
Sections du résumé
BACKGROUND
Informed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research.
METHODS
In a sample of parents with young children, we used a mixed method approach to study the user experience of an informed consent app and evaluate whether it can be used to adequately inform people and register their consent. Through semi-structured interviews we investigated participants' experiences with and opinions about the app, with a special focus on comprehensibility of the content and the usability of the app. Information retention questions were asked to evaluate to what extent participants could recall key aspects of the provided study information.
RESULTS
The 30 participants in this study used the app between 4 and 15 min to give their consent. Overall, they found the app well-designed, informative and easy to use. To learn more about the study for which informed consent is asked, most of the participants chose to watch the animated film, which was generally found to convey information in a clear manner. The identification process was met with mixed reactions, with some feeling it as a secure way to give consent, while for others it contradicted their view of using data anonymously. Information retention questions showed that while all participants remembered various aspects of the study, fewer than half answered all four questions satisfactorily.
CONCLUSION
Our study shows that a well-designed informed consent app can be an effective tool to inform eligible participants and to record consents. Still, some issues remain, including trust barriers towards the identification procedure and lack of information retention in some participants. When implementing consent procedures that incorporate digital formats, it may be beneficial to also invest in a complementary face-to-face recruitment approach.
Identifiants
pubmed: 37941000
doi: 10.1186/s12910-023-00974-1
pii: 10.1186/s12910-023-00974-1
pmc: PMC10634039
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
97Informations de copyright
© 2023. The Author(s).
Références
Behav Res Methods. 2019 Jun;51(3):1426-1440
pubmed: 29943224
BMC Med Ethics. 2013 Jul 23;14:28
pubmed: 23879694
Fam Pract. 2008 Apr;25(2):127-31
pubmed: 18304975
JMIR Pediatr Parent. 2021 Mar 5;4(1):e23842
pubmed: 33666558
JBI Database System Rev Implement Rep. 2015 Oct;13(10):82-94
pubmed: 26571285
AJOB Empir Bioeth. 2017 Jul-Sep;8(3):178-188
pubmed: 28949896
BMC Med Ethics. 2022 Nov 21;23(1):117
pubmed: 36414962
J Empir Res Hum Res Ethics. 2015 Dec;10(5):444-8
pubmed: 26564942
J Nurs Scholarsh. 2014 Nov;46(6):423-31
pubmed: 25130209
BMC Public Health. 2017 Mar 23;17(1):276
pubmed: 28330465
BMJ Open. 2022 Jul 13;12(7):e057508
pubmed: 35831055
PLoS One. 2013;8(3):e58603
pubmed: 23484041
J Empir Res Hum Res Ethics. 2016 Feb;11(1):31-46
pubmed: 27106889
Am J Surg. 2009 Sep;198(3):420-35
pubmed: 19716887
JAMA. 2004 Oct 6;292(13):1593-601
pubmed: 15467062
J Empir Res Hum Res Ethics. 2018 Oct;13(4):338-348
pubmed: 29790410
J Empir Res Hum Res Ethics. 2014 Dec;9(5):1-7
pubmed: 25747685
Am J Med Genet A. 2014 Jan;164A(1):129-40
pubmed: 24273095
Contemp Clin Trials Commun. 2016 Feb 17;3:32-38
pubmed: 29736454
BMC Med Ethics. 2021 Feb 27;22(1):18
pubmed: 33639926