The summary report for 2017 is now available to download.
The Radiological Protection Ordinance (RPO) has been totally revised and entered into force on 1 January 2018. Some of the modifications relating to research also concern the Clinical Trials Ordinance (CTO) and the Human Research Ordinance (HRO):
- The existing limit values are replaced by dose constraints. The legal consequences when a dose is exceeded are thus kept within reasonable bounds (each time a limit value is exceeded it must be treated as a major accident). The value remains at 5 mSv or 20 mSv per person (per year, research projects without expected benefit for the participants), see Art. 45 StSV.
- The first four paragraphs and the first three paragraphs have been added in Art. 44 CTO and in Art. 23 HRO respectively. These new paragraphs introduce an inspection commitment of the administered effective dose as well as a requirement to notify the competent cantonal ethical commission for cases in which the dose constraint is exceeded. Category B and C clinical tests with ionising radiation-emitting therapeutic products also need to be notified to Swissmedic. The new provisions supplement the previous reporting obligation and are intended to ensure immediate measures in order to prevent further exceedances and in all cases the necessary care of the persons concerned. The ethical commissions and Swissmedic may now obtain specialist advice from the FOPH in cases in which an opinion of the FOPH was not previously envisaged.
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.