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Appendix 1. Overview of the approval process for human subjects research

Overview of the approval process for studies with data

Health science research projects that must be approved by the Health Research Ethics Committee

Danish Medicines Agency

Health Research Ethics Committee (REC)

AU Research Ethics Committee (in cases in which the project falls outside REC system)

The Danish Patient Safety Authority Data supplier AU’s register or CDM’s register1 The Danish Data Protection Agency
Interventional studies with medicinal products X X X
Interventional studies with medical devices X X X
Other interventional studies X X
Health science research projects that do not require approval by the Health Research Committee
Data from patient records X X
Register-based research, data from national databases and/or registers X X
Where also processing outside the territorial scope of the GDPR – plus approval Data Protection Agency X
Where publication in a recognised journal or similar – and data not anonymous – plus approval Data Protection Agency X
Observational studies as well as interviews and questionnaires X X

1  Research projects with patient data can either be registered in CDM’s or AU’s research project register depending on affiliation.



Overview of approval of trials with biological material

Register-based research, databases and/or registers with biological material

Creation of a biobank Research from biobank (disclosure)

1) Research biobank (specific research purpose)

 
  • Health Research Ethics Committee
  • Informed patient consent to the collection of biological material for the biobank
  • AU register or CDM register
 
 
  • AU register or CDM register
  • The Danish Data Protection Agency

2) Biobank for future research (research project not defined)

 
  • Separate informed patient consent to the creation of a biobank for future research
  • AU register or CDM register
 
 
  • Health Research Ethics Committee
  • Informed patient consent for a new specific research purpose, unless a waiver has been obtained from VEK for the new research purpose) AU register or CDM register
  • The Danish Data Protection Agency
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