[Changes in the "medical research" licensing procedure under the German Radiation Protection Ordinance]

Abstract

This publication outlines the "medical research" licensing procedure as specified in the amendment of the German Radiation Protection Ordinance of November 1, 2011. The general licensing requirements for the use of radiation have not been changed by the amendment. Three so-called use restrictions (i. e., dose limits of 10 mSv and 20 mSv, age limit of 50 years) have been modified. They will only apply to healthy volunteers in the future. In addition, there are considerable simplifications with respect to applications and licensing procedures of the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS) regarding the use of radiation in the newly introduced "accompanying diagnostics" ("Begleitdiagnostik") case group. The newly established, independent panel of experts at the German Radiological Society (Deutsche Röntgengesellschaft, DRG) may provide essential support to principal investigators, qualified physicians and sponsors for differentiating between "medical research" and "health care", the latter not being subject to licensing. An expert statement will be issued by the DRG within four weeks of an inquiry. This consulting service is subject to confidentiality, and is free of charge for inquirers and without any commitment.