What is it? Why is it important?
The Ordinance on Organisational Aspects of the Human Research Act (OrgO-HRA) defines any required organisational procedures regarding:
- The Ethics Committee (EC)
- The Federal Office of Public Health (FOPH)
It provides information on:
- Institutional composition (e.g. member requirements)
- The organization of each entity (e.g. scientific secretariat, withdrawal from consent)
- Respective tasks and duties (e.g. stakeholder coordination, decision making procedures)
In addition, the OrgO-HRA regulates data protection such as:
- Disclosure of personal data to authorities
- The exchange of data with foreign authorities and institutions
What do I need to do?
This ordinance mainly provides required structural information to the EC and the FOPH.
Consequently, for the planning and implementation of human studies, you do not often refer to this ordinance.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
FEDLEX – law is available online under numbers
- 810.308 OrgO-HRA