JMIR Publications

ABSTRACT

Background:

Informed consent (IC) is one of the key elements in biomedical research. The introduction of electronic IC (eIC) can be a way to overcome many challenges related to paper-based IC. However, its novel opportunities remain largely unfulfilled due to several barriers.

Objective:

This literature review aims to provide an overview of the ethical, legal, regulatory and user interface perspectives of multiple stakeholder groups to assist responsible implementation of eIC in biomedical research.

Methods:

We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library and PsycARTICLES. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was used for reporting the current work. We included empirical studies focusing on the concept of eIC in biomedical research covering the ethical, legal, regulatory and user interface domains. We critically appraised included literature 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 to retrieve the results. Most of the studies’ population was represented by research participants. The majority of studies addressed barriers to achieve adequate understanding when using eIC. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an eIC platform and the usability for vulnerable participants.

Conclusions:

eIC has the potential to improve the current paper-based IC process in biomedical research. The ethical, legal, regulatory and user interface perspectives outlined in this review might serve to achieve an advantageous future state of eIC