Confusion around GDPR means 'few clinical trials take place in Ireland’, conference will hear

Cancer Trials Ireland linked the overly rigid application of GDPR in Ireland to the extremely low number of cancer trials involving patients from Irish hospitals. Picture: Peter Byrne/PA

An absence of clear guidance on applying GDPR between Irish hospitals or between EU countries is one reason why so few clinical trials take place in Ireland, a conference will hear Monday.

It comes after Cancer Trials Ireland linked the overly rigid application of GDPR in Ireland to the extremely low number of cancer trials involving patients from Irish hospitals.

These trials can be life-saving for the patient taking part and open pathways to better treatment for many more people.

Over 3,500 industry-sponsored clinical trials began across Europe in the first six months of 2024, but only 11 trials included Ireland.

Royal College of Surgeons Ireland (RCSI) ethics lecturer Mary Kirwan said the conference will bring patient advocates, the Data Protection Commission and researchers together to discuss a major issue in healthcare and development in Ireland.

“One of the biggest issues is the administrative burden that data protection generates for researchers,” she said.

“The other thing is complexity in terms of interpretation, so how GDPR, the Data Protection Act and health research regulations are interpreted and applied on the ground.” 

The problem is in different hospitals you are going to get different interpretations and that is difficult.

This can cause delays if a study is shared by different sites as researchers try to find a middle ground.

Also, she said: “The problem gets even worse when you go outside of Ireland.” 

Each EU country can interpret the rules around health data differently as is allowed under legislation.

Ms Kirwan, also a barrister, said overall: “There is a lack of clear guidance on interpretation of GDPR at EU level.

“At the end of the day it’s about patients and Irish patients having the benefit of access to research. It improves care for patients.” 

The conference will discuss several other barriers which potentially deter sponsors from conducting clinical trials in Ireland.

These also include complex regulatory requirements and approval setup for studies which can be time-consuming and onerous. The protection of data for patients will also be discussed.

The Health Research Data Protection Network conference is hosted by RCSI today.

A paper on potential solutions will be published at a later date. This will be distributed to the relevant stakeholders.