What is it? Why is it important?
The Federal Human Research Act (HRA) is a Swiss with the aim to protect the dignity, privacy, and health of human beings involved in research.
The HRA applies to research concerning human diseases, structure and function of the human body, involving:
- Deceased persons
- Embryos and foetuses
- Biological material
- Health-related personal data
The act is designed to:
- Create favourable research conditions
- Help to ensure research quality (e.g. quality assurance)
- Ensure research transparency (e.g. publication)
A total of four ordinances are derived from the HRA:
HRA does not apply to research which involves:
What do I need to do?
As a SP-INV and Site-INV, performing studies involving human beings, you are required to know and comply with the requirements defined in the HRA.
Read the HRA and the applicable ordinance applicable to your study:
- Be familiar with the organisation of the various chapters and sections
- As applicable, tag articles you are required to comply with
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
HRA – see in particular articles
- Art. 1 Purpose
- Art. 2 Scope