On November 1st, essential updates to the Federal Act on Research involving Human Beings (HRA, SR 810.30) and its ordinances came into force, including: 

• The Ordinance on Clinical Trials; ClinO

• The Human Research Ordinance; HRO

• The Organisational Ordinance HRA; OrgO-HRA

• The Ordinance on Clinical Trials with Medical Devices; ClinO-MD.

These updates address several areas, such as electronic consent (e-consent), anonymization and coding requirements, transparency, and data governance obligations.

To support everyone in adapting to these changes, we have integrated these updates into the Regulatory Framework for Switzerland! As with the previous version, the updated framework is recognized by Swissethics.

Learn more about it here: Switzerland Regulatory Framework 2024.

Best regards,

The TRREE Team