GDPR Impact on Clinical Trials

Within the next six weeks, the General Data Protection Regulations (GDPR) is set to be enacted in all European Union (EU) member states. These regulations, which come into force on May 25, affect all EU states but also any businesses that have employees or clients who are EU citizens.

The intent is to protect the privacy of all EU citizens. To that end GDPR is a landmark document unprecedented in the last two decades. Individuals and companies found to be non-compliant will face heavy fines.

Data subjects must give prior consent to the collection and use of their data. They must be informed in clear and concise language of what is being processed and exactly how it will be used.

Data subjects have the right to access their personal data file. They may review it for accuracy and request that certain information be deleted, or corrected.

They may specify that certain items be modified or used exclusively for a certain purpose. They have the right to be forgotten before or after clinical trials take place.

Businesses and organizations must appoint a data protection officer. A process must be in place to receive, review, act on, or deny individual requests concerning their personal data.

How does GDPR Impact Clinical Trials

Because clinical trials make more use of electronic records, electronic transmitting of files and Internet research sources, it has become even more challenging for companies and organizations conducting clinical trials with GDPR new stipulations about personal data.

Data security and personal data privacy are the major issues in this area.

Clinical trial data fits into the new GDPR guidelines under ‘special data’. This means that this data and its processing are required for purposes of “science or research”.

When individuals consent to be part of clinical trials, under GDPR, they must give specific and detailed consent to their data being collected, processed, stored and used in those clinical trials.

They must give informed consent, meaning that it is clearly stated by the company how the data is being collected, what data is being collected and how it will be used. They have the right to have their data removed from the trials and they have a right to know how the clinical trials affect the portability of this data.