My son was diagnosed with cancer in 2013 at the age of 8 years. He relapsed twice since, in 2016 and in 2019.

So, as I was preparing my speech, I realised that we had lived through the entry into force of the General Data Protection Regulation. Our first forms were clearly less detailed than the last one and Raphaël was also, for the first time, involved in the decision process when he had turned 15.

Patients love The General Data Protection Regulation. We are deeply convinced that the privacy it warrants our data is fundamental because this protection makes it acceptable, safe… to consent to sharing our data for research purposes.

We place our hopes in research to improve existing treatments and our quality of life and we are convinced that GDPR will help future patients to accept to also participate in research.

As a result, this regulation is one of the best means to increase and accelerate data collection and as a result, advance research.

However, as any new legislation, GDPR created frictions that we had not anticipated and that we would now like to see sorted out.

The first hurdle we witnessed along the way is that informed consent forms are much too long and complex for most patients. Information needs to be adapted to its audience and not only does too much information kill information but also technical terms prevent patients from adhering to the project. If we want all patients to understand what the research plan is about, the plan needs to be laid out in plain language.

There is also one other reason why detailed and technical information forms are counter-productive: a detailed explanation on a research project will never turn a patient into either a scientist able to validate the quality of a research project or an ethicist able to distinguish morally sound research topics. On the contrary, patients want to trust researchers and funders in their capacity to identify what makes a research project relevant and ethical committees in their reasonable judgement to approve decent projects. And patient experts must be part in those validation stages.

What we really care about is that our data be fully protected and safely stored without any risk of leak to economic or commercial players who could use our data against our own interests. This is what we really want to read about in the consent forms: how will our data and samples will be protected, and if shared, in what kind of context?

Sharing our data will always be riskier than refusing to do so. If we accept that risk, we really want our data to be used to their fullest extent. We want our contribution to be meaningful and we hope to have an impact.

We know that research today requires the creation of big data sets to discover patterns.

Big data sets are important in all disease areas but in the field of paediatric cancer, this matters to a wholly different level because all paediatric cancers are rare. Not a single Member State can claim to account for enough patients to create a relevant database in paediatric oncology. We need those data to be shared across countries and projects. As a result, data sharing must be encouraged facilitated.

Instead, today, we witness hurdles both at national and institutional levels. National privacy authorities have diverging interpretation of GDPR and conservative legal departments in universities find it easier to refuse data sharing because saying no reduces their liability risks.

Parents and survivors would be surprised and probably utterly disappointed to hear that the data they donated could not be used to their full potential because they were not shared. Those data or blood or tumour samples were given at great cost for them: let’s make it count and make sure that they can be safely shared to advance research.

Finally, many survivors are here now too to tell us that even if they were only kids when they underwent treatment, they would have wanted to understand what was going to happen with their data and samples. As from the age of 7, children can understand a lot when explained in simple words.

I witnessed that with my own son. No one, including me, explained him what would happen to his amputated foot after the surgery. He came back with the question a couple of years later and I realised that he should have been explained – he was nine at the time, perfectly able to understand. Child-friendly information should be available for patients aged 7 or above and they should be thanked for their contribution.

GDPR makes it possible for member states to implement an age of assent where young patients can express their opinion on the treatment or research as from the age of 13 or more. This rule fluctuated in several member states and is not uniform. It should also be part of the regulation and young patients should have the same rights across with the ability to assent as from the age of 13.

If we sum this up in actions:

• We want informed consent forms to be drafted in plain language; patients do not intend to become the judges of the quality of a research project; in other words, we care more about how our data will be protected along the course of their research life
• The quality of a research project must be assessed by funding bodies and ethical committees and patient experts should be included in those assessments because they have the tools for such that role and they can identify what matters for our community
• Detailed and technical informed consent forms can lead to a restrictive interpretation of how our data can be used and this is exactly what patients want to avoid: as long as research projects are validated by experts, including patients, we want our data to deliver as much scientific progress as they can
• We want child-friendly information for patients above the age of 7; they should understand what we are going to do with their ‘body parts’ and they should be thanked for their contribution to research
• We want harmonised interpretation of GDPR and means to avoid hurdles at the institutional level; in rare disease, size really matters and we lose opportunities when data cannot be shared to create bigger data sets