|Federal Office for Radiation Protection||Bundesamt für Strahlenschutz (BfS)|
|The Federal Office for Radiation Protection, also known by its German acronym BfS, employs more than 500 people and has its headquarters in Salzgitter. It also has headquarters in Berlin, Neuherberg, Bonn, Rendsburg and Freiburg im Breisgau. BfS is a higher federal authority and part of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety.
BfS is currently responsible for the areas of radiation and environmental protection as well as radiation protection in health. The latter is the most relevant for medicine and clinical research and is divided into “Effects and risks of ionising and non-ionising radiation” and “medical and occupational radiation protection”.
What role does BfS have in clinical trials? If a clinical study uses radioactive materials, x-rays or ionising radiation for medical research on human beings, the BfS must first give their approval. This is laid down in Section 31 of the Radiation Protection Act (StrlSchG).
For example, examinations requiring approval include scintigraphy, positron emission tomography (PET), radionuclide therapy or radiation using accelerators as well as computed tomography, mammography, conventional x-rays, or bone density measurements. Magnetic resonance imaging (MRI) and ultrasound examinations can be performed without requiring approval from the BfS.