JMIR Publications

ABSTRACT

Background:

The expansion of decentralized and digital health research has increased reliance on remote data collection, renewing attention to the ethical foundations of informed consent. As a core requirement of health research, informed consent protects participants’ rights and underpins ethical and regulatory compliance. Electronic remote consent, which delivers and documents consent through digital rather than in-person paper processes, is increasingly adopted, yet its ethical and legal implications warrant systematic examination.

Objective:

This scoping review examined these implications and synthesized recommendations for best practices relative to traditional paper-based consent approaches.

Methods:

The review, conducted in January 2026, synthesized literature from Ovid MEDLINE, Ovid Embase, and Web of Science. Search terms addressed three concepts: (1) remote and electronic consent, (2) health research, and (3) ethical and legal implications.

Results:

Sixteen peer-reviewed articles published between 2017 and 2025 met the eligibility criteria and were charted by two reviewers and thematically analyzed. Although remote consent is becoming more common, standardized implementation guidelines remain limited. International frameworks offer guidance on data privacy, health equity, and consent validity, though application across jurisdictions is inconsistent. Four cross-cutting themes were identified. First, inconsistent terminology limits comparison and points to the need for a standardized framework describing consent by synchronicity, delivery medium, and researcher involvement. Second, remote consent offers benefits including increased autonomy, participant satisfaction, and delivery standardization, but raises comprehension concerns, particularly under fully asynchronous models. Third, remote consent expands access for rural, remote and mobility-limited participants, but may exacerbate inequities in digital literacy, internet access, and technology availability. Fourth, successful implementation and outcomes depend on infrastructure, governance, training, and regulatory compliance rather than technology alone.

Conclusions:

Remote consent in decentralized research offers an opportunity to improve access, efficiency, and participant experience, yet ethical and legal guidance has not kept pace with its uptake. These findings position remote consent as an integrated process shaped by how it is defined, validated, distributed, and resourced. The results provide a conceptual and practical foundation for designing robust remote consent processes for digital health research.