It’s the GDPR article that guarantees participants in clinical trials the right to access their personal data processed by the sponsor or investigators, ensuring transparency regarding how their health information is used during the study.
- GDPR Info Europe https://gdpr-info.eu/art-15-gdpr/#:~:text=Article%2015%20of%20the%20GDPR%20gives%20data,copy%20of%20the%20personal%20data%20undergoing%20processing
To go in depth
Article 15 of the GDPR works in conjunction with the Clinical Trials Regulation (CTR 536/2014) to ensure that patients are informed and have control over their sensitive information at every stage of the research.
Here is how this law governs the participants’ rights:
- Confirmation and Access to Data: the participant has the right to obtain from the data controller (usually the study sponsor) confirmation as to whether personal data concerning them is being processed and, if so, to obtain access to such data.
- Copy of Data: the participant has the right to receive a copy of the personal data being processed, which may include clinical documentation generated during the trial.
- No charge: in principle, exercising this right is free of charge.
- Additional information: in addition to providing access, the data controller must inform the data subject of their right to request rectification, erasure, restriction of processing, or objection, as well as their right to lodge a complaint with a supervisory authority.
Limitations on the right: although the right of access is fundamental, it must be balanced against the need to maintain the integrity of trial data (often pseudonymized). The guidelines, in fact, emphasize the importance of protecting patient data, even though they do not override transparency obligations.
