Introduction
As wearable technologies become more prevalent in clinical trials, they bring not only innovation but also complex ethical challenges. Ensuring informed consent, protecting participant privacy, and addressing digital literacy gaps are now central to Good Clinical Practice (GCP) compliance. This post explores the evolving ethical landscape and how researchers can uphold participant rights in the digital age.
1. Informed Consent in the Age of Digital Health
Informed consent is a cornerstone of ethical research. However, when digital tools like wearables are involved, the process becomes more nuanced:
- Complex Data Practices: Participants must understand how their data will be collected, stored, analyzed, and potentially reused. This includes third-party access, cloud storage, and AI-driven analytics.
- Terms of Service Transparency: If commercial devices are used, researchers must explain the device’s terms of service and privacy policies, which may not align with research ethics.
- Ongoing Consent: Given the continuous nature of data collection, consent should be treated as an ongoing process — not a one-time event.
2. Addressing Digital and Data Literacy
Not all participants are equally equipped to understand digital technologies:
- Digital Exclusion: Individuals with limited access to technology or low digital literacy may be unintentionally excluded from trials.
- Accessible Communication: Researchers must use plain language, visual aids, and interactive tools to explain complex data flows and risks.
- Equity in Participation: Providing training or devices can help bridge the digital divide and promote inclusivity.
3. Privacy, Confidentiality, and Data Ownership
Wearables collect highly sensitive, continuous data — raising serious privacy concerns:
- Data Minimization: Only collect data that is necessary for the study’s objectives.
- Participant Control: Participants should be able to opt out of data sharing beyond the study or for future research.
- Encryption and Secure Storage: Research-grade wearables should use encrypted data transmission and GDPR/HIPAA-compliant storage.
4. Institutional Review Board (IRB) Considerations
IRBs must evaluate new risks introduced by wearable technologies:
- False Positives and Overdiagnosis: Devices may trigger unnecessary interventions due to inaccurate readings.
- Unblinding Risks: Data access must be carefully managed to avoid compromising trial blinding.
- Secondary Use of Data: IRBs must assess whether future use of collected data is ethically justified and clearly communicated.
5. Ethical Use of AI and Algorithms
When wearable data are analyzed using AI:
- Transparency: Participants should know if AI is used and how it may influence decisions.
- Bias and Fairness: Algorithms must be validated to avoid reinforcing health disparities.
- Consent for Algorithm Training: Participants should be informed if their data will be used to train future AI models.
Conclusion
Ethical research in the digital era requires more than regulatory compliance — it demands empathy, transparency, and a commitment to participant empowerment. By rethinking informed consent and prioritizing privacy, researchers can ensure that wearable-enabled trials are not only innovative but also just and inclusive.
Interested in learning more about GCP auditing? Stay ahead of regulatory expectations with expert training and audit support. Contact us today! ClinAudits, LLC- Cheri Wilczek, President-email: cheri.wilczek@clinaudits.com; phone: 973-492-8108 extension 111. Our website is: www.clinaudits.com.
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