Further education for EC members
General assembly swissethics 2018
New version (v3.1, 31.03.2018): Notification and reporting to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO). The leaflet describes also the notification and reporting of SAEs and SUSARs to the Ethics Committee. In German, French, Italian and English.
A paragraph was added on the notification of the device deficiencies in clinical trials of medical devices, as per Art. 42 para 1b, ClinO.
New version (v2.0, 08.03.2018) Technical Assistance System. In German and French:
The definition of technical assistance systems was revised and clarified. Additionally, the scope of the position paper was narrowed after Swismedic review.
New version (12.03.2018): Scale of fees. In German and in French.
Only administrative changes, no changes were made to the fees.
An inform sheet about the “Effects of the new Radiological Protection Ordinance (in force since January 1, 2018) on human research” has been added on swissethics.ch under legislation-guideline / Switzerland / at the federal level.
The document is available in German, French, Italian and English.
Save the date: Further education for EC members
This year training for EC members in German takes place in Zürich, Landesmuseum, on November 13, afternoon. The EC members will be informed with a dedicated ‘save the date’ Newsletter, shortly.
General Assembly swissethics 2018
The general assembly revised the statutes during the General Assembly on 27 March 2018. The responsibility and administration of BASEC has been added under the aim and purpose of swissethics. Additionally, the ‘Ausschuss’ (steering committee) has been strengthened as an operational body with each EC being now represented by at least one member. The board is now composed of the presidents and of a legal representative. The list of members of the steering committee and of the board will be published on the webpage shortly.
The general assembly has also decided with majority to provide the FOPH with the final report on the visits to the ECs and with the evaluations of the pilot projects referred to in the swissethics Annual Report 2017. These documents will be used by the FOPH for the evaluation of the HFG. Moreover, the general assembly decided unanimously to support the project to introduce an e-consent within the framework of personalised medicine.
The swissethics Annual Report 2017 is available in German and French on swissethics.ch.
A note has been added to remind the applicants to remove all local ECs when switching back from multi-EC to just one EC on screen 1. The note only shows up if the form still has at least one local EC checked, but the number of sites is set to 1 (monocentric).
All key decisions taken by the board, by the ‘Ausschuss’ (steering committee) and by other relevant instances are compiled and summarized in an excel Pivot table which is available to the presidents and the scientific secretaries on the cloud (link to the cloud here). Please contact swissethics if you do not have access to the cloud or if you can no longer access it.
That’s it !