Effects of the new Radiological Protection Ordinance (in force since 1 January 2018) on human research
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.