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Here’s a short EU #dataprotection thread relating to some of the work I‘ve been doing on #researchethics. The #GDPR is broadly a very good thing but it’s starting to look like a bit of a car crash for established ethical standards in research (1)
Why? A combination of highly effective market research lobbying for business as usual together with wider demands to “repurpose” data for “research” pushed EU negotiators into lowering the data protection bar for “research” activities across the board (2)
Fine you might say, research is very important and we shouldn’t overregulate. But what it means in practice is that once someone has your data, it is now much fairer game for “research” purposes (3)
Important “safeguards” and “balancing” tests apply, but their application is open to interpretation and accountability is largely ex-poste (4)
Here’s the opinion of the EDPB on the interplay between the GDPR and the EU clinical trials directive in which the Board puts clear blue water between “informed consent” in a research setting and “informed consent” to data processing: edpb.europa.eu/sites/edpb/fil… (5)
It argues that IC as derived from decades of research ethics shouldn’t be confused with IC in a data protection context, which has a different meaning in both law and practice (6)
While this is perfectly true at face value, the Board could and I think should have recommended that researchers bring the former into line with the latter, rather than treating them as chalk and cheese (7)
Board cites problems in obtaining consent from vulnerable persons, but research ethics has been dealing with this challenge for yrs. It simply ignores this experience and recommends that in a CT researchers should base their processing on alternative “legal bases” where poss (8)
The GDPR indeed encourages this, but what it means in practice is using what is in effect a much more permissive regime than a robust IC procedure based on solid medical ethics and the old Directive would have allowed (9)
Those alternative “legal bases” include compliance with legal obligations stemming from the clinical trials directive itself, the public interest in the public health outcomes, the “legitimate interests” of the data controller, or “compatible” secondary uses of the data (10)
What I fear will happen is people withdrawing their consent to participate in a research project, which was once taken to mean automatic deletion of their data (with some legit exceptions), may now have to make specific GDPR representations to take their data with them (11)
And, of this I’m absolutely certain: scrupulous and less scrupulous researchers everywhere poring over the GDPR to avoid consent and direct notification processes in their processing – as they are perfectly entitled to do under the law (12)
Also: new nightmares for Research Ethics Committees, which were already struggling to understand requirements of the old DP Directive and have little hope of pushing back on GDPR-savvy researchers performing GDPR sleight of hand to legitimise dubious or unethical practice (13)
Not suggesting that the EDPB has misread the legislation in any way, but in wanting to avoid ‘ambiguity for data subjects’ it has left research ethics committees and research participants facing exactly that, and then some (14)
Some of this headed back to the regulators and possibly the courts. In the meantime, remember kids: just because something is legal, doesn’t mean it's ethical. But its 2019 and you knew that already (end)
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