swissethics is looking for a projekt manager and serving as deputy managing director (60-80%)

26.05.2025

Annual safety and general progress trial report for clinical trials with medical devices

05.05.2025

As announced on February 18 (see News 18.2.2025 below), swissethics is today publishing a new template for writing the annual safety and general progress trial report for clinical trials with medical devices.

Artificial Intelligence and research involving human beings: Issues to consider when submitting a project to a research ethics committee

17.04.2025

swissethics published a guiding document on issues to consider when submitting a project on artificial intelligence (AI) to a research ethics committee. The purpose of this document is to support research involving AI through a set of indicative questions outlining the basic AI-specific issues that ethics committees expect to be covered in research protocols.

Election of the President and Vice-Presidents at the General Assembly on March 18

25.03.2025

At the general assembly, Dr. Susanne Driessen, St.Gallen, was re-elected as president of swissethics. Three new vice-presidents were elected: Prof. Dr. Maja Beck Popovic, Lausanne, Dr. med. Beatrice Giberti Gai, Bellinzona and MLaw Regula Steiner, Bern.

GCP-courses recognition by swissethics: Adaptation to the Principles and Annex I of the revised ICH E6(R3), to the Declaration of Helsinki and to ISO/DIS 14155

25.02.2025

swissethics reminds GCP course providers to update their courses to the Principles and Annex 1 of the revised ICH E6(R3), to the updated Declaration of Helsinki of October 2024, and to ISO/DIS 14155 «Clinical investigation of medical devices for human subjects – Good clinical practice».

Adoption of ICH Guideline E6(R3)

24.02.2025

On 6 January 2025, the Principles and Annex 1 of the revised ICH Guideline E6(R3) were adopted at the international level. They will come into effect in the EU region on 23 July 2025. In line with this schedule, the Principles and Annex 1 are also to come into effect in Switzerland in summer 2025. Annex 2 will be adopted at a later date, coming into effect in the EU and in Switzerland no earlier than the beginning of 2026.

Annual Safety and General Progress Trial Report

18.02.2025

Regulations for health-related personal data registries

17.12.2024

swissethics publishes a new template for regulations for health-related personal data registries. This template defines the ethical and regulatory requirements necessary for the conduct of further use research projects with the data from registries.

UPDATE: Revision of the HRA Ordinances

17.10.2024

Publication of the 'Swiss specific addendum' for clinical trials according to ClinO

Swissmedic and swissethics have communicated that applications under the ClinO that are submitted before November 1, 2024, under the old law can only be approved under the new law after November 1, 2024.

UPDATE: Revision of the HRA Ordinances

16.09.2024

Publication of the updated templates

Instructions on the procedure for submitting applications before 1 November 2024

The revision of the ordinances of the Human Research Act (HRA), which will come into force on November 1, 2024, requires numerous adjustments for investigators and authorities. The most important aspects of the revision concern the «protection of participants» and the improvement of the «framework conditions for research».