Find out more! These changes come into force on 1 November 2024. The SCTO offers several free online seminars.

Revision of legislation 

The ordinances implementing the Law on Research Involving Human Subjects (ClinO, ClinO-MD, HRO, OrgO-HRA) were recently revised by the Federal Council. 

The main changes for researchers concern participants' right to information and communication of results; transparency for clinical trials (publication of results); appropriate inclusion of participants according to age and sex; electronic consent for participants (e-consent); anonymisation and coding of biological material and personal data relating to health; categories of clinical trials; retention period for biological material and personal data relating to health.

The amended ordinances will come into force on 1 November 2024, with the exception of the provisions relating to transparency, which will come into force on 1 March 2025. The templates and consent forms are currently being updated by Swissethics. Do not forget to download the latest versions!

A summary of the main amendments is available here. The Legal Department is available to answer any questions you may have about this revision and the legislation on human research.

The Swiss Clinical Trial Organisation (SCTO) is holding an online seminar on this revision for researchers on Monday 28 October 2024 from 12:00 to 13:00. For further information, click here.

Online seminars on HRO research projects

The SCTO is offering a new series of online seminars on observational studies and projects involving further use of personal data and biological material. The topics covered are:

• Mastering Consent: Key insights into general and informed consent for HRO projects (2 October 2024, 12:00-13:00)
• Data sharing and open research data - details for HRO projects (13 November 2024, 12:00-13:00)
• Sample management and biobanking - essentials for HRO projects (4 December 2024, 12:00-13:00)

For more information, click here.

Fees charged by Swissmedic for academic clinical trials

As of the 1st of July 2024, sponsors of clinical trials for medicinal products, medical devices and novel therapies that are not financed by commercial third-party funding may apply for a fee reduction. Fees will be reduced by 80% for the processing of applications and reports for such clinical trials. The request can also be made for an ongoing trial. For further information, click here.