1. Research ethics in The Netherlands dr Annelien Bredenoord & prof dr Hans van Delden UMC Utrecht Julius Center The Netherlands A.L.Bredenoord@umcutrecht.nl

2. Research ethics I Research ethics as review practice Strongly developed in the NL for medical research Almost absent in other fields II Research ethics as academic specialty within medical ethics UMC Utrecht has taken research ethics as its core business

3. I Research ethics as review Legal basis: European Union directive (GCP), Council of Europe (Oviedo), national law (Medical Research Involving Human Subjects Act, 1998)

4. I Research ethics as review Central level “Dutch model”: organised centrally with a national committee on medical research with humans (‘CCMO’) Power to create local REC’s/IRB’s Interpretation of law and regulations Review of protocols in certain cases (non-therapeutic research in children, embryo research, cell therapy e.g.)

5. I Research ethics as review Local level Some 30 local committees, usually in academic or teaching hospitals UMC Utrecht: ~430 protocols per year Work is divided over three chambers 13% of protocols rejected

6. I Current issues in NL What research should be reviewed? Dutch law defines ‘scientific research’ as: ‘medical research, part of which involves subjecting persons to actions or imposing certain behaviors upon them'.  What about observational? Non-medical? (Definition of UK Medical Research Council includes study of samples!) Biobank research Broad consent acceptable? Draft Control on Human Tissue Act

7. I Current issues in NL Research with vulnerable groups (e.g. children) What threshold for non-therapeutic research? Minimal risk & burden Doek Committee Task of REC: improving or reviewing research?

8. II Research ethics as academic focus Medical Humanities group within epidemiological department (Julius Center) Great opportunity for synergy with people trained in methodology, statistics and (genetic) epidemiology Only ethics group in NL specialized in research ethics 2 full time professors (med history, med ethics) 4 assistant professors 10 PhD students

9. II Main research lines UMC Utrecht Research ethics Innovative biomedical research Adaptive trials Genomics (whole genome sequencing, biobanking) Vulnerable groups Children Research in palliative care Justice in international research Choice of research populations

10. Thank you Contact data: Annelien Bredenoord UMC Utrecht A.L.Bredenoord@umcutrecht.nl T +31 88 755 1351