What is it? Why is it important?
- The implementation of research projects that sample Biological Material (BM) and collect Health-Related personal Data (HRpD) from participants in order to:
- Answer a scientific question
- Make further use of BM and HRpD for research purposes
- The handling of BM and HRpD that is collected as per routine procedures for further use in research
General provisions include to ensure the:
- Scientific quality and integrity of the project
- Qualification and training of researchers
- Adherence to the Ethics Committee (EC) / FOPH authorisation and notification procedures
- Compliance with data protection law (e.g. collection, storage, and sharing of biological material and HRpD)
The obligation of an additional approval by the FOPH is only applicable to projects that include the use of a radiation source(s).
Human research projects may be based on the collection or reuse of BM or HRpD from patients e.g. further-use studies), healthy volunteers, deceased persons, embryos and foetuses, and spontaneous or induced abortions including stillbirths.
What do I need to do?
As a project leader conducting a research project in Switzerland, responsibilities include to:
- Manage overall project coordination (e.g. finances, study initiation, management)
- Protect research participants
- Comply with data protection laws
- Have the professional qualification, training, and experience required to conduct a research project
- Implement appropriate measures so as to ensure correct handling, storage, and maintenance of BM and HRpD (e.g. infrastructure, biobank set-up, access rights, documentation)
- Submit a project application to the EC / FOPH for approval
The HRO ordinance differentiates between:
- Prospective research projects involving the collection of (non-routine) BM / HRpD
- The handling of BM and HRpD that is collected as per routine procedures for further-use in research
Based on project type, different requirements apply (e.g. ICF procedures, EC approvals, data collection or retrieval procedures, clinical project report).
- Apart from EC submission, project financing and the overall coordination of the research project, the Site-INV carries the same responsibilities as the project leader - only at the local site level.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
HRO – see in particular articles and chapters
- Art. 1 Purpose
- Art. 5 Storage of health-related personal data and biological material
- Chapter 2 Research involving measures for sampling of biological material or collection of health-related personal data from persons
- Chapter 3 Further use of biological material and health-related personal data for research