COREON Sessie op WEON 2021: Informed consent for observational research in context
This is an updated version – due to unforeseen circumstances we had to modify the program of the COREON session.
There is lively debate in Europe whether further use of patient data for statistical and scientific purposes should always be based on informed consent or, if not true informed consent, at least some form of general consent. The General Data Protection Regulation leaves this issue largely to the member-states.
In this session we looked at the debate and how various countries in Europe have found different solutions to generate real world data for a learning health care system.
The Dutch system is on the more strict side of this spectrum. It is discussed how the coming Dutch Code of Conduct aims to strike a balance within the confines of the European and Dutch legislation. The Dutch legislation leaves a narrow margin to abstain from asking consent if it can be proven that this leads to ‘bias’.
The still ongoing COREON literature review of empirical evidence on bias created by informed consent procedures in observational research is briefly presented.
By the way, it is certainly still possible to participate in this project. The outcomes should give researchers arguments to use the bias issue within the confines of the Dutch legislation but perhaps also to change the Dutch legislation bringing it more in line with other European countries.
But some ethicists will disagree, arguing that problems of internal validity and generalizability weigh less than autonomy also in low-risk observational health research. Hence, the chance of bias should not have a place in the law or only be invoked very exceptionally.
- Prof.dr. R. Verheij (Nivel): Informed consent versus no objection in the learning health system (pdf) and via YouTube
- E.B. van Veen Ll.M (MLCF): Dutch Legislation on Further Use in Context (pdf) and via YouTube
- Prof. dr. G. van Thiel (UMCU): Governance of (big) health data research (pdf) and via YouTube