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Ethical Considerations in Decentralized Clinical Trials.

Barbara E Bierer¹, Sarah A White²

¹Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA. bbierer@bwh.harvard.edu.

Journal of Bioethical Inquiry

|March 1, 2024

Summary

Decentralized clinical trials increased during COVID-19, offering benefits like better access but raising ethical concerns. Addressing participant safety, privacy, and remote consent is crucial for future ethical and accessible research.

Keywords:

Bioethics Decentralized clinical trials Digital trials Electronic Consent Hybrid trials Remote trials

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Area of Science:

Clinical Research
Public Health
Bioethics

Background:

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials (DCTs).
DCTs offer potential benefits including enhanced participant access, convenience, and efficiency.
However, DCTs introduce unique ethical and practical challenges.

Purpose of the Study:

To identify and discuss key ethical and practical concerns associated with decentralized clinical trials.
To highlight the importance of addressing these challenges for the future of clinical research.

Main Methods:

Review and analysis of ethical and practical considerations in decentralized clinical trials.
Focus on specific areas: participant safety, privacy, remote consent, digital access, and trial oversight.

Main Results:

Decentralized clinical trials present significant challenges in participant safety and data privacy.
Remote consent processes and ensuring digital access and proficiency require careful management.
Effective trial oversight is critical in a decentralized research environment.

Conclusions:

Awareness of ethical complexities in DCTs is essential for developing effective solutions.
Future DCTs require optimized processes to ensure participant safety, confidentiality, and accessibility.
Collaborative efforts are needed to promote ethical and participant-centered decentralized research.