European scientists say proposals to amend the EU's Data Protection Framework will make vital research "at worst illegal and at best unworkable." Science Europe's Professor Richard Frackowiak tells DW why.
DW: In an open letter published on Wednesday (29.01.2014), you and other signatories say that amendments to the Data Protection Framework, which have been adopted by the Civil Liberties and Home Affairs committee of the European Parliament would make the use of personal health data in research without specific consent "impossible in practice." Why do you need access to personal data? What exactly does personal data give you in research that you wouldn't have if you didn't have that personal data?
Professor Richard Frackowiak: There's a lot of medical research on data which doesn't need to be personal - in fact, the vast majority - and these data are anonymized data. There are [other] situations where you might need personal data. For example, take a disease such as HIV...We find the cause, and we would like to go back to the people who have the disease and treat them. In those sorts of situations you work on data which are anonymized, but you have a key. So if you work on a computer, you will know that you can encrypt your disk. So you encrypt your disk, which means you make all the personal stuff disappear but you have a key, which you can plug in and bring it all back. Some people call that pseudo anonymized. It has been in use for many years. It is governed by ethical committees, so you have to go through special procedures to be able to get at those data and you have to have a very good reason, too. The third, much rarer situation, with nasty or rare diseases, where you've had someone's data and you have access to it for research purposes on an anonymized basis, but you really need to get to them to treat them. In those situations you need to get at the personal data quickly, and effectively and efficiently.
So what is the problem with getting personalized and specific consent for each case?
Well, you could take a sample of my blood today for a specific task and keep that blood in a 'fridge, and in five years time there may be another extremely vital bit of research that needs to be done, and that blood should be part of the results…Now, would you go ahead and spend all that money on collecting more when you've already got it there?
No, but the point is that if you've collected the blood, why not collect the consent at the source?
You do. There are procedures for collecting consent for specific projects, but there are also procedures which are open, which allow people to give consent for any research in the future. And there have been very good examples from Germany. In Hamburg, the cancer registry, which was extremely helpful in cancer research, eventually had to shut down because laws were introduced which suggested that for every bit of tissue that was taken, you needed to give permission for one specific research project. And if you wanted to do any more with it, you needed to go back, and find the individual, although the individual may have died or you may not have been able to trace him or whatever…Now those rules have changed, people give permission for all research, always keeping their names out of it […], and then you can do your research as necessary. That has to go through ethics committees, of course. You can't do research on tissue without a proper project, and being properly funded…the research committee system works extraordinarily well.
Your tissue belongs to society
Surely, even from a scientific and research point of view, you can understand the climate we're in right now, the data protection framework needs renewal…
Life is more important than the climate. And it's a climate which is uninformed opinion essentially…We have a system which works. The [European Commission] realized that it works and put in specific things into its proposal for the regulation, which gave exemptions for particular types of medical research, and the parliamentarians have now got involved because they think that somehow people's personal data will be used for disreputable things. They simply haven't done their home work, I'm afraid. Privacy is not at issue here. People's lives are at issue. And the other thing that you must consider is that every piece of tissue taken in a socialized health system is not only the patient's but also belongs partly to society because everyone in society pays tax in order to have that tissue taken. Now, clearly if you have tissue taken completely privately and pay for it yourself, then you have absolute rights to it. But I would submit that in a socialized health system, and public health is an important aspect of that socialized health system…When you get treated, there is information which is yours, but there is a little bit of information which belongs to every member of society which pays for it.
But I think that the problem that people have is that if you take, for example, the UK Personal Genome Project, there are people who willingly take part in the sharing of their personal data, and at the same time there are plenty of people who say that it's not only about the people who take part in the project but it's also about the relatives, people who are yet to be born. So there are data that can affect people who are not directly involved in your research, or in the case of this UK Personal Genome project who will also be affected, and it's very difficult to take into account the rights and opinions of people who are not present when you take that initial blood sample.
Yes, I think that's a reasonable thing to say. But take things like Huntington's Disease…These things have been worked out so that people go to genetic neurologists to find out their risk, and they make personal decisions on whether or not they inform their families…All these things are a part of routine medical practice. But when it comes to research, and the specimens are anonymized, there's no way that's going to impact on anyone in the future. You're not even going to know yourself.
Professor Richard Frackowiak is the chair of Science Europe's Medical Sciences Committee. Science Europe is a lobby group representing scientists and is funded by general research funding organizations across Europe.