Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Abstract

Background Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

Personalized and long-term electronic informed consent in clinical research: stakeholder views

“…Several interviewees highlighted that paper-based IC documents are difficult to understand due to the scientific and legal nature of the information and emphasized the importance to present information in an understandable and engaging manner to research participants. eIC can assist in this by making use of video, audio or graphics to convey information to participants, which is considered more effective than written text [ 19 ]. Nevertheless, a small number of interviewees were convinced that eIC would not influence the understanding of research participants compared to that of a paper-based IC.…”

“…Semi-structured interviews were conducted to seek the views and experiences of various stakeholder groups across Europe and the United Kingdom (UK) regarding (electronic) IC in clinical research. An interview guide was developed based upon a systematic literature review and the research aims [ 19 ]. This systematic literature review identified that more research regarding the personalization of an eIC platform and the long-term interaction with research participants was required.…”

“…Specifically, there is a need for structured insights regarding how an eIC platform (through which research participants are able to manage their eIC) may be effectively personalized and also on how the long-term interactions may be established. A complete overview of the aspects of an eIC platform that are acceptable to personalize is currently lacking [ 19 ]. With regard to the long-term interactions, it is necessary to determine which results may be shared with the research participants via eIC.…”

Real-Time Dynamic Tiered e-Consent: A Novel Tool for Patients' Engagement and Common Ontology System for the Management of Medical Data

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Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach

“…Advances in technology have led to new opportunities to support the informed consent and assent process ( 19 ). Participatory methods have previously been proposed to involve patients in informed consent and assent design ( 20 ).…”