[Data protection--an obstacle for prospective studies? Solutions exemplified by a cohort study]

Area of Science:

• Epidemiology
• Public Health
• Data Management

Background:

• Prospective studies necessitate long-term storage of participant personal data for follow-up.
• Ensuring data protection and participant's right to self-determination are critical ethical considerations.
• The European Prospective Investigation into Cancer and Nutrition (EPIC) study requires robust data security protocols.

Purpose of the Study:

• To describe the data protection measures implemented in the EPIC-Potsdam study.
• To detail the role and function of an internal trustee in safeguarding participant data.
• To demonstrate how data security can be maintained without compromising research integrity.

Main Methods:

• Establishment of a spatially and organizationally separated internal trustee working group.
• Implementation of an isolated electronic data processing network and enhanced physical security (alarm systems, access control).
• Anonymization techniques including replacement of identification numbers, unique document identification, and selective data access for staff.

Main Results:

• The internal trustee successfully collects follow-up information (vital status, diseases) from various sources.
• Security arrangements effectively protect participant personal data through anonymization and controlled access.
• Data protection measures streamline workflows and ensure follow-up compliance with international standards.

Conclusions:

• The internal trustee model in the EPIC-Potsdam study provides a secure framework for prospective cohort data.
• Strict data protection protocols safeguard participant privacy while facilitating efficient data collection and research.
• These measures uphold ethical standards and ensure the validity of long-term epidemiological research.