News
Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
16.03.2021
On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices.
If you are planning to submit a new clinical investigation with a medical device before May 26, 2021, or if you currently have a clinical investigation with a medical device under review by the ethics committee, we strongly advise you to read on the swissethics.ch website how the transition of such investigations is to be regulated.
Weblinks to the instructions in English, German, French and Italian on the swissethics.ch website.
Weblink to the newsletter of April 1st 2021.
Publication in Jusletter: Human research, further use and informed consent
02.02.2021
swissethics was mandated by the FOPH, Human Research Section, in 2020 to prepare a structured analysis on the further use of health-related personal data and biological material and the application of Article 34 HRA (link to the report in German).
Read moreswissethics publishes recommendations on research adapted to gender
16.12.2020
Gender equity in research is an important issue: there are significant differences between men and women in many clinical drug trials, as well as in non-clinical trials with persons or in research projects of further use of health-related personal data and biological material.
The published recommendations address essential steps towards equitable research between the sexes, with ethics commissions playing an important role in the evaluation of the applications.
Guidance document on the use of food stuffs and food supplements in research
07.12.2020
swissethics has published a short guidance document regarding the use of food stuffs and food supplements in research. These products could be classified as investigational medicinal products (IMP) according to ClinO, in which case they would have to be made according to GMP and be submitted to the ethics committee and Swissmedic.
Read moreInformation on the coronavirus: new and updated document “Joint guidance document on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic”
05.11.2020
Due to the current situation, changes were introduced in the document “Joint guidance of swissethics - Swissmedic on the conduct of clinical trials during COVID-19 pandemic”. Details related to the changes are outlined in the guidance paper.
swissethics and SwissPedNet publish a guidance document on: inclusion of adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication
30.09.2020
When including adolescents/adolescents in a clinical trial, there are many ethical questions and complex implications such as the possibility of pregnancy in minors and the contraceptive measures to be used depending on their physical and psychological development.
Read moreswissethics publishes four updated templates of the patient information and consent forms for research participants in the context of research with persons
20.09.2020
swissethics publishes four updated templates of the patient information and consent forms for research participants in the context of research with persons: The patient information and consent forms for clinical trials and non-clinical trials are made available to the participants themselves or - if they are lacking capacity - to their legal representatives (or relatives).
Read moreGuidance document for the researchers for the conduct of basic research projects
16.07.2020
It is often unclear whether a basic research project falls within the scope of the Human Research Act (HRA) or not. This depends on whether it is research according to the definition of the HRA (generation of generalisable knowledge), whether it is a research into the function and structure of the human body and whether biological, human material and the data are used in uncoded, coded or anonymised form.
Read moreUpdated submission Form “RESEARCH PROJECT APPLICATION FORM”: New question on the declaration of interests of the principal investigator(s)/institution(s).
13.07.2020
A question on ‘declaration of interests’ of the principal investigator(s)/institution(s) has been added to the form for the submission of clinical trials and research projects. The question is mandatory for all new submissions and for already approved/ongoing clinical trials and research projects. If the question is not answered, the form will display an error on screen 14 preventing the submission of the amendment/changes.
Read moreCovid-19: Changes for the Ethics Committees March to June 2020: Challenges and effects on the number of applications and on the timelines
01.07.2020
The Covid-19 pandemic has posed new and very serious challenges to ethics committees and all other institutions involved in human research. In an overview document swissethics has compiled the most important aspects of the Covid-19 pandemic of the past months for the ethics committees. It shows how the researchers were supported by extremely short processing times despite a considerably larger number of research applications. In addition, ethical standards are discussed, particularly with regard to informed consent. The document is published in German and in French.