News
Summary report of the HRA working group with proposals for the revision of the law and the ordinances
17.07.2018
In recent months, a swissethics working group has drawn up proposals to show where the ethics commissions believe the Human Research Act (HRA) and the ordinances need to be revised. The final summary report, written in German, can be accessed under the following link. This document is aimed at all stakeholders who are involved in research involving human beings and at the legislator. The proposals are to be considered as a basis for the further dialogue.
Notification of safety events through a new dedicated Safety Form
06.06.2018
Starting June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications, other safety notifications) must be done exclusively through the new Safety Form. This also includes the submission of documents that contain information which reveals treatment assignment in a double-blind study. The submission of safety reports by email or through the main application form will no longer be accepted.
Please read the corresponding FAQ on how to use the new Safety Form before submitting any safety document. Failure to comply with the instructions may result in inspection findings.
The safety form is available under “submit an application / forms available”.
BASEC: Notification of safety events through a new dedicated Safety Form
06.06.2018
The online-platform BASEC (Business Administration System for Ethics Committees) to submit research project has a new feature: there is now a dedicated separate form for notifications of safety events to Swiss Ethics Committees.
Read moreGeneral Data Protection Regulation, GDPR
23.05.2018
On 25.5.2018 the European Data Protection Regulation (GDPR) comes into force. swissethics has therefore updated the legal disclaimer (available in German and French).
RoPS (Registry of ongoing Projects in Switzerland)
11.05.2018
RoPS (Registry of ongoing Projects in Switzerland) is the new registry of all research projects approved by the ethics committees and ongoing in Switzerland, for the general public.
Read moreGeneral Data Protection Regulation (GDPR), also relevant for Switzerland
17.04.2018
On 25 May 2018, the new General Data Protection Regulation (GDPR), will enter into force in the EU, which will also require immediate action in Switzerland for further, smooth international data traffic. In Switzerland, the Federal Act on the Data Protection (FADP, SR 235.1) is currently under revision. Various cantons will also adapt their data protection legislation.
Read moreAmendment to Annex I of the Clinical Trials Ordinance (ClinO) as of 1 May 2017
01.05.2017
The ICH-GCP Guideline of 10 June 1996 was amended by the International Harmonization Conference on 9 November 2016.
Read moreSilent Approval
11.07.2016
The following changes and documents are acknowledged by the Swiss cantonal ethics committees by means of a „Silent Approval“:
Read moreThe EC St. Gallen merges with the EC Thurgau
01.06.2016
On June 1st 2016 the ethics committee of the Canton St. Gallen merges with the ethics committee of the Canton Thurgau. The new created Ethics Committee East Switzerland (EKOS) is so responsible for the cantons SG, TG, AR and AI. The EKOS has its office in the city of St. Gallen.
BASEC
17.12.2015
swissethics wishes to thank all applicants, who already used the new web portal BASEC to submit their new projects. All submissions were received without problems.
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