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In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC

Publications swissethics

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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.

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Covid-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.

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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.

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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.

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.

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