In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC
Publication of guiding principles for registries in human research
Which data collections in human research are subject to authorisation by an ethics committee and when is the consent of the participants or their information on the right to dissent required?Read more
Guideline and swissethics-template for drafting additional information (addendum) for study participants in line with the General Data Protection Regulation (GDPR)
In exchange and cooperation with data protection experts and representatives of the pharmaceutical industry, swissethics publishes a recommendation on the application (or non-application) and an addendum template to the patient information on the European General Data Protection Regulation (GDPR) within the framework of research in Switzerland. The document is available in German, French and Italian.
Summary report of the HRA working group with proposals for the revision of the law and the ordinances
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.
BASEC: Notification of safety events through a new dedicated Safety Form
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 more
General Data Protection Regulation, GDPR
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).