Basic↦Biobanking↦The Swiss Law↦Human Research Ordinance
What is it? Why is it important?
The Human Research Act (HRA) regulates through its Human Research Ordinance (HRO):
- The implementation of research projects that sample Biological Material (BM) and collect health-related personal data (HRpD) from donors to (HRO, Chapter 2):
- Answer a scientific question
- Make further-use for research purposes
- The handling of already collected BM and HRpD for further-use in research (HRO, Chapter 3)
General provisions include to ensure the:
- Scientific quality and integrity of the project, which provides confidence in research results
- Qualification and training of researchers
- Adherence to EC/FOPH authorisation and notification procedures
- Implementation of data protection laws
What do I need to do?
As a project leader you are responsible for:
- Conducting a research project in Switzerland
- Protecting participants on the research site
- Organising the research project (e.g. initiation, management, EC approval, financing). An alternative SP-INV can take on this responsibility
- The ongoing professional qualification and training of all research staff involved
- The correct handling and storage of BM and HRpD (e.g. infrastructure, access, documentation)
Whether you plan a research project with BM/HRpD or you want to make further-use of already collected BM/HRpD, make yourself familiar with the respective requirements provided by the law.
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
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
Ethical / Legal
- Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland
HRO – see in particular articles and chapters
- Art. 1 Purpose
- Art. 2 Applicable provisions
- Art. 3 Project leader responsibilities
- Art. 4 Professional qualifications
- 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