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Research ethics in The Netherlands

Research ethics in The Netherlands. dr Annelien Bredenoord & prof dr Hans van Delden UMC Utrecht Julius Center The Netherlands A.L.Bredenoord@umcutrecht.nl. Research ethics. I Research ethics as review practice Strongly developed in the NL for medical research

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Research ethics in The Netherlands

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  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

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