News
Guidance 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.
Implementation: guiding principles for registers in human research
02.06.2020
Advisory opinion of the ethics committees on registers, biobanks and research projects in accordance with Art. 51 HFG
The pure creation of data registries or biobanks is not formally subject to authorisation under the HRA. However, projects that re-use these data and biological samples must generally be approved by an ethics committee. The ethics committees now offer a preliminary examination of the data registries and biobanks.
Read moreNew submission Form available: Advice on ethical questions/comments on research projects not subject to the HRA.
02.06.2020
Use the form "Advice on ethical questions/comments on research projects not subjet to the HRA" to obtain an advice on a data registry or on a biobank (without a concomitant submission of a research project), or to obtain comments on a research project not subject to the HRA, and specifically projects carried out abroad. The research project must be close to the ethics committee’s area of expertise. The form fulfils the requirements set by Article 51 lit 2 HRA.
The mission of the Ethics Committees during the COVID-19 Pandemic
06.05.2020
The ‘European Network of Research Ethics Committees’ (EUREC), of which swissethics is member, has released a position paper on the responsibility of Research Ethics Committees during the COVID-19 pandemic.
EUREC reaffirms and reminds all concerned parties (researchers, institutions, sponsors, …) that the mission of the Ethics Committees is the protection of the dignity, rights, safety and well-being of research participants, in medical research, and that this also applies against the background of the current pandemic situation.
Read moreInformation on the coronavirus: In order to promote transparency and facilitate research coordination, swissethics is now also publishing research projects that have been submitted but not yet approved.
30.03.2020
The current situation of the corona pandemic is extremely challenging for all health care institutions involved. The ethics commissions are currently receiving a large number of submissions of projects on corona research. Understandably, the interest in evaluating patient data on new therapies, analysing cohorts or evaluating data on certain pre-existing conditions is extremely high.
Read moreInformation on the coronavirus: new and updated document “Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic”
26.03.2020
The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland.
Swissmedic and swissethics have therefore published a joint document ("Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic"), which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products. The document can be viewed on the respective Swissmedic and swissethics websites.
Information on the corona virus
24.03.2020
Please consult the dedicated COVID-19 website on swissethics.ch for news on the corona virus, guidance documents on the conduct of clinical trials and research projects in Switzerland, and other information. The COVID-19 website is updated regularly with new information, as it becomes available.
To promote transparency and facilitate the coordination of research on COVID-19, swissethics now publishes all approved and all submitted clinical trials and research projects on the dedicated COVID-19 website. Researchers are kindly asked to find out which projects are already underway in order to avoid national duplications. Should you oppose to that, please contact swissethics at info@swissethics.ch before you submit the project.
Information on the coronavirus
18.03.2020
Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland must ensure that the studies are conducted in line with the COVID-19 Ordinance 2 (available in German (PDF), French (PDF) and Italian (PDF), issued by the federal government on 16 March 2020.
In particular, participants over the age of 65 and participants with underlying medical
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