Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review

Decentralized clinical trials (DCTs) leverage digital health technologies to conduct trials outside traditional settings, offering numerous benefits such as increased participant diversity and breaking down geographic and transportation barriers. However, they also present significant ethical challenges. Current regulatory and ethical frameworks are not fully equipped to address these issues, highlighting a critical gap in effective governance and oversight of DCTs. This scoping review aims to systematically identify and synthesise the ethical challenges reported in the literature and to outline recommendations that can inform future guidance and practice.

This scoping review followed Arksey and O'Malley's framework. We searched PubMed, Web of Science, and SCOPUS for peer-reviewed articles in English and applied predefined inclusion and exclusion criteria to guide study selection.

The initial search yielded 757 documents. After applying inclusion and exclusion criteria and conducting a rigorous two-stage screening process, 32 articles were selected for detailed analysis. These articles identified six main areas of ethical challenges: electronic informed consent, equity and access, privacy and confidentiality, participant safety and welfare, scientific validity, and ethical and regulatory oversight.

This review underscores the necessity for clear guidelines, enhanced digital literacy, robust data protection measures, and comprehensive regulatory frameworks to address the ethical challenges of DCTs. By synthesizing existing literature, this paper provides actionable recommendations, such as simplifying consent processes and improving technical support, and identifies areas for future research to ensure DCTs are conducted ethically and effectively.