News
Information on the corona virus
16.03.2020
The corona virus also does not stop at the ethics commissions. Not all the scheduled committee meetings can be held regularly at the various locations. This means that there may be delays in the decision-making process and therefore deadlines cannot always be met. The ethics committees thank you for your understanding.
Nevertheless, the reviews and approvals of studies investigating the disease or investigational medicinal products for COVID-19 are of course treated with priority.
We thank you for your cooperation in this critical situation. In individual cases, the ethics committees are available to answer questions on this matter directly.
Quality assurance, or research project subject to approval?
04.02.2020
Sometimes it is not really clear when submitting an application whether it is a research project to be approved by the ethics committee or a pure quality control, which according to the HRA is not subject to approval and therefore does not have to be submitted to the ethics committee.
Read moreChanges to the project registry of swissethics
24.09.2019
Since 2016, swissethics has regularly published clinical trials and research projects that have been approved by the competent ethics committees in Switzerland. The focus was on "ongoing" clinical trials and research projects (RoPS, Registry of ongoing projects in Switzerland).
From now on, all clinical trials/projects will be published. Consequently, those that have already been completed can also be found in the register. Thus, the registry has been renamed RAPS: Registry of All Projects in Switzerland
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.