The new year has started with changes in the Ordinances ClinO and HRO.
In particular, the articles ‘Assessment, notification and reporting on the use of radiation sources’ of both Ordinances (Art. 44 ClinO and Art. 23 HRO) have been modified to require the Investigator, resp. the project leader, to notify the responsible ethics committee if the permitted dose guidance value was exceeded at any time. The notification must occur within seven working days.
Additionally, the responsible ethics committee may obtain specialist advice from the FOPH in order to assess the dose calculation or the dose estimation and to decide what further measures are required.
Here below you find the direct links to the concerned Ordinances and articles: