Electronic Informed Consent in Biomedical Research - a Systematic Review of Stakeholders' Perspectives
Author(s)
De Sutter E1, Zace D2, Boccia S2, Di Pietro ML2, Geerts D3, Borry P3, Huys I3
1KU Leuven, Leuven, VBR, Belgium, 2Università Cattolica del Sacro Cuore, Rome, Italy, 3KU Leuven, Leuven, Belgium
OBJECTIVES Electronic informed consent (eIC) has the potential to increase retention by facilitating better understanding of research participants. However, adoption of eIC is slow due to several barriers. Therefore, this study aimed to systematically review perspectives of stakeholders in the ethical, legal, regulatory and user interface domains to achieve trustworthy implementation of eIC in biomedical research. METHODS We systematically searched the literature using Web of Science, PubMed, EMBASE, ACM Digital Library and PsycARTICLES. Empirical studies were included covering perspectives of stakeholders with regard to eIC in biomedical research. We focused on studies written in English and published after 2010. Depending on the study design, quality was appraised using the Newcastle-Ottawa scale, the Critical Appraisal Skills Programme, the Mixed Methods Appraisal Tool and the Jadad tool. RESULTS This systematic literature review included 40 papers. The majority of included studies reported perspectives of research participants, followed by researchers, ethics committees (ECs) and health authorities. Research participants highlighted the benefit of a personalized eIC platform which enables research participants to customize the platform based on their needs and preferences. eIC may also impact the inclusivity of biomedical research since subtitles or voice-overs can be used to present information in several languages. Researchers and members of ECs expressed concerns regarding compliance with local regulations. Moreover, security of personal data was considered a core aspect to enable trust for clinical study participation. CONCLUSIONS This literature review provides a multi-stakeholder perspective on eIC in biomedical research. Our results indicate the potential benefit of eIC by facilitating research participant engagement in biomedical research. However, future participant-centered research is necessary to further explore the effect of eIC considering the age, education level and health status of the participants. Moreover, collaboration with all stakeholders is needed to address their concerns and ensure meaningful eIC implementation for all stakeholders.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PNS196
Topic
Epidemiology & Public Health, Health Service Delivery & Process of Care, Medical Technologies, Patient-Centered Research
Topic Subcategory
Digital Health, Hospital and Clinical Practices, Patient Engagement, Public Health
Disease
No Specific Disease
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