Assessment & Approval

Overarching ethical considerations

All clinical trials require ethical review, including DCTs.  However, the regulatory and ethical review system was designed for conventional (site-based) trials. To fully realise the promises of DCT approaches, the ethical context needs to be aligned with the practice of DCTs to safeguard responsible conduct.

Recommendations

People participating in a DCT experience positive outcomes beyond the direct therapeutic benefit, Ethics reviews often emphasise the potential risks and burdens associated with DCTs, potentially overshadowing the direct and collateral benefits participants may experience, such as receiving medical devices, reduced travel time, or enhanced health literacy. We advocate for explicitly including these collateral benefits in ethical evaluations to make risk-benefit assessments more balanced, fair, and participant-centred.

The soft impacts of DCTs are difficult to measure or predict. These includes shifting responsibilities, changes in existing relationships within the healthcare and research context, new impacts on privacy, and trust. We also considered the broader soft impacts of digital technologies, such as how they shape behaviours, social interactions, and personal values. Recognising these influences. We recommend to monitor and document a broad range of effects and experiences as part of DCTs to align digitalisation ethically and practically with participant needs.

The increasing use of digital health technologies and AI-driven systems in DCTs changes traditional oversight and responsibility structures and may diffuse responsibilities among multiple actors. Diffusion diminishes the ability of actors to fulfil responsibilities related to ethical conduct of trials. Clearer frameworks are required to effectively map responsibilities, address risks, and establish robust communication channels among stakeholders, ensuring accountability and efficient management of DCT approaches.

These scenarios also include accompanying advice for researchers on ways of mitigating challenges and proposals for adjustments of the regulatory framework. They outline four critical areas for ethical and responsible DCT implementation: enhancing participant-centricity through empowerment and reducing trial burdens via technology; careful and justified collection of real-world data; maintaining rigorous oversight to ensure participant safety; and clearly defining and effectively pursuing diversity goals within trial populations.

How Trials@Home reached these recommendations

We conducted an extensive review and assessment of ethical issues in DCTs through stakeholder interviews and a mock ethics review involving members of European ethics committees and national competent authorities. Our analysis extended beyond traditional concerns such as data protection, safety, and quality, also exploring softer impacts like the effects on social relationships, behaviours, and values. Based on this comprehensive approach, we developed four innovative scenarios to guide the creation of a responsible and sustainable DCT ecosystem.

Scenario 1: Enhancing Participant-Centricity
DCTs aim to reduce the burden on participants by allowing trial activities to occur in their own environment, improving flexibility and integration into daily life.

Scenario 2: Real-World Data Generation
DCTs collect data in participants’ natural settings rather than controlled clinical environments. This makes the data more reflective of real-life conditions, allow for more relevant measurements, improving data accuracy, protocol compliance, and participant retention.

Scenario 3: Improving Efficiency
DCTs can streamline trial processes by reducing in-person visits, enabling remote delivery of medications, and using digital monitoring for safety oversight.

Scenario 4: Increasing Population Diversity
DCTs may improve the inclusivity of clinical trials by removing geographic and logistical barriers. This can make participation easier for underrepresented groups such as the elderly, people with comorbidities, those in rural areas, and minority populations.

Further reading

Publications

Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.

van Rijsel, et al
Drug Discovery Today
2022
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View poster version

Which Benefits Can Justify Risks in Research?

van Rijssel, et al
The American Journal of Bioethics
2025
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The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account.

van Rijssel, et al
Health Care Analysis
2024
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Diversity in decentralized clinical trials: Prioritizing inclusion of underrepresented groups.

van Rijssel, et al
BMC Medical Ethics
2025
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Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials.

Muller, et al
Drug Discovery Today
2025
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Deliverables

Overview of innovative scenarios for a responsible and sustainable DCT ecosystem.

WP EAGLE, 2023
Read now