Quality and transparency in clinical research

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:

Quality and transparency in clinical research

The 2018 annual report of the Coordination Office for Human Research (kofam) is now available to download

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.

Overview of developments relating to medical devices

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:

New regulations for clinical trials of medical devices

The website will be kept up to date to reflect the latest developments.

Current FOPH research projects

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:

New EU rules on clinical trials on medicinal products

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:

Clinical trials on medicinal products for human use in the EU

New online tool for research projects involving radiation

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.