RWE 201 – Italy – CCNCE – Ethical and Regulatory Issues in the Processing of Patient Data in Observational Research

 

CCNCE Reflection Paper (Apr 2023): https://www.aifa.gov.it/documents/20142/1808580/Criticita_etiche_ricerca_osservazionale_06.04.2023.pdf

The Italian National Coordination Center of Territorial Ethics Committees (CCNCE) has released a comprehensive document discussing the ethical and regulatory challenges surrounding personal health data processing in observational research.

Key Points:

[1] Importance of Observational Research: Observational studies are foundational in the medical research domain. In a 2019 survey by CCNCE, 50% (7,400) of approximately 14,800 studies reviewed by Ethics Committees were observational. Retrospective studies made up more than half of these, leading to around 4,500 such studies annually in Italy. Observational research strengths lie in the vast health data registers and long observation periods. The COVID-19 pandemic accentuated the significance of timely analyzing pre-collected data.

[2] Regulation and Ethical Evaluation: Current clinical trial legislation inadequately covers observational research. Bureaucratic hurdles in observational studies can lead to increased costs and operational challenges. Two major ethical issues arise:

  1. Data processing from/by patients.
  2. Additional procedures outlined in the research Protocol.

The latter was discussed in a 2022 CCNCE publication.

[3] GDPR and Data Processing: GDPR (Regulation EU/2016/679) addresses the use of registers in research. CCNCE also scrutinizes the legal bases provided by GDPR and its relevance in personal data processing during observational studies.

[4] Proposals for Enhanced Data Processing:

  1. New Regulation: Suggestions from public institutions emphasize data collection quality. The “Reform Scheme of Health Information Systems” (January 2022) suggests clearer data collection intentions, legal architecture, and transitioning from pre to post data processing control.
  2. Shared Data Governance: Recognizing data as a shared resource, a “data access committee” (DAC) is recommended to control data access. The European Data Governance Act also backs such data sharing facilitation.
  3. Accountability Rethink: The Superior Council of Health suggests transitioning from pre-processing authorization to post-processing checks. This involves sharing general research details and establishing a notification system for easier post-process checks.
  4. Revamping Consent: New forms of consent like “Broad Consent” and “Dynamic Consent” are explored. The latter allows participants to dynamically decide on their data usage over time.

Conclusion: To address personal health data’s ethical and regulatory issues in observational research, CCNCE proposes:

  1. Uniform pseudonymization rules.
  2. Moving beyond traditional consent methods.
  3. Promoting researcher accountability, consulting the Guarantor for potential processing risks, and encouraging post-process control for data processing exclusively for research purposes.
Share this story...