What is it? Why is it important?
The Federal Human Research Act (HRA) is the Swiss law aimed at protecting 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, which involves:
- 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
- Ensure research transparency
A total of four ordinances are derived from the HRA:
HRA does not apply to research which involves:
- IVF embryos in accordance with the Stem Cell Research Act (StRA)
- Anonymised biological material
- Health-related data collected anonymously (e.g. participant is unknown) or anonymised (e.g. upon collection data is rendered anonymised, participant can no longer be identified)
What do I need to do?
When performing studies involving human beings, you are required to know and comply with the requirements defined in the HRA act.
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 relevant articles that need to be complied with in your study
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 – laws are available online under numbers
- 810.30 HRA
- 810.305 ClinO
- 810.306 ClinO-MD
- 810.301 HRO
- 810.308 OrgO-HRA
- 810.31 StRA
HRA – see in particular articles
- Art. 1 Purpose
- Art. 2 Scope