The Federal Office of Public Health ordered an analysis of the effectiveness of the Human Research Act (HRA). The results of the evaluation form the basis for several proposals for improvement.
On 6 December 2019, the Federal Council acknowledged the results of the evaluation and decided to undertake a partial revision of the HRA’s ordinance legislation.
You’ll find more information on the FOPH website:
The Coordination Office for Human Research (kofam) has the legal mandate to provide the public with information about the work of the ethics committees. To this end, every year it produces a summary of the annual reports of the individual committees. Parallel to this, this year it is also publishing a statistical report in line with the legal requirement to produce a statistical overview of the research projects that have been approved.
The 2018 summary report and statistical report can be found here and in the Downloads section:
The FOPH is actively monitoring developments in the European Union regarding the EU regulations on medical devices. Starting in August 2019, the FOPH will publish regular updates on the implementation of the regulations in the EU and its member states. The reports will appear in English an can be found on the following webpage:
The findings of the federal government research project commissioned by the FOPH are now available. The study examined what impact international guidelines and the Human Research Act HRA have had on study protocols of clinical trials before and after the entry into force of the HRA.
The final report on the federal government research project and further information can be found via the following link:
The report describes kofam’s activities from the past year and picks out some of the highlights. It also provides an outline of ongoing and future activities.
On the FOPH website you can now find information on how the EU’s Medical Device Regulation (MDR) will affect human research in Switzerland and what consequences it will have for Switzerland:
The website will be kept up to date to reflect the latest developments.
The Federal Office of Public Health (FOPH) commissions so-called departmental research projects looking into specific policy-related, economic and social issues.
These projects are practical, problem-oriented, and as a rule interdisciplinary, functioning as an interface between science and practice.
The following new research projects initiated in the course of evaluating the Swiss Human Research Act (HRA) have now been completed:
From the end of 2020 there will be new regulations in place in the EU governing clinical trials on medicinal products. The Federal Office of Public Health (FOPH) commissioned a study to find out the extent to which the new rules will also affect Switzerland. You’ll find more information on the FOPH website:
The Coordination Office for Human Research (kofam) now offers researchers a tool for categorising research projects involving radiation. It is relevant for research projects with therapeutic products capable of emitting ionising radiation and for accompanying inquiries with radiation sources. The tool comprises an interactive decision aid that researchers can use to determine the appropriate procedure for submitting their application, plus nine different schemes showing in graphical form the procedures for submitting applications and notifications to the ethics commissions, Swissmedic and the FOPH’s Radiation Protection Division.