News
Position paper of swissethics on how to manage incidental findings in medical research
06.08.2019
Im Rahmen der Humanforschung gibt es durch Diagnostik und Untersuchungen in einem nicht unerheblichen Prozentsatz im Rahmen von klinischen Studien und Projekten Zufallsbefunde.
Read moreUpdated Guidance for providers of courses on Research Ethics and GCP: new including GCP Refresher courses
06.08.2019
Since 1 January 2014, GCP course providers can have their GCP courses for investigators and sponsor-investigators in Switzerland recognised by swissethics.
Read moreImportant remarks on the information on the "Temporary authorisation to use medicinal products in accordance with Article 9b paragraph 1 HMG" of 13.3.2019
10.04.2019
The information published by swissethics on 13.3.2019 is aimed at pharmaceutical companies, i.e. sponsors who can apply for a temporary authorisation for their drug under certain conditions.
Read moreThe total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019.
13.03.2019
AMBV Chapter 5 regulates the temporary authorisation for the use of medicinal products in accordance with Art. 9b Para. 1 TPA. The procedures formerly known as "compassionate use" (now temporary authorisation) refer to therapeutic products whose efficacy has already been proven in clinical trials.
Read morePublication of version 2 of the national General Consent
22.02.2019
With the General Consent (GC), persons treated in hospital can consent to the further use of their personal data and samples for research projects. unimedsuisse, together with swissethics, publishes today the version 2 of the national GC.
Read morePublication of guiding principles for registries in human research
19.02.2019
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 moreGuideline and swissethics-template for drafting additional information (addendum) for study participants in line with the General Data Protection Regulation (GDPR)
02.10.2018
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
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 more