Appendix 1. Overview of agencies who approve health science research projects and health science data research projects

Overview of the approval process for studies with data

Health science research projects and health science data research projects that require approval by the Health Research Ethics Committee
	The Danish Medicines Agency	Health Research Ethics Committee (REC)	Research Ethics Committee at AU(in cases in which the project falls outside the REC system)	Region	Data supplier	AU’s register or CDM’s register[1]	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
Sensitive bioinformatics data		X				X
Health science research projects and health science data research projects that do not require approval by the Health Research Ethics Committee
Observational studies as well as interviews and questionnaires			X			X
Register-based research, data from national databases and/or registers					X	X
Non-interventional studies of medicinal products						X
Data from patient records				X		X
Research projects where the Danish Data Protection Agency must be notified
Where there is also processing outside the territorial scope of the GDPR							X
Where publication in a recognised journal or similar – and data is not anonymous							X

* Non-CE labelled equipment or CE labelled equipment used for other purposes

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 for 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 for 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
3. Anonymous biological material	No registration requirements	No registration requirements