This page contains information for researchers and sponsors of clinical trials and research projects during the ongoing 2019–20 coronavirus pandemic (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Information 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”
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.
Covid-19: Changes for the Ethics Committees March to June 2020: Challenges and effects on the number of applications and on the timelines
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.
The mission of the Ethics Committees during the COVID-19 Pandemic
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 more
Information 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.
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 more
Information 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”
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.