Ordinance
on Human Research with the Exception of Clinical Trials
(Human Research Ordinance, HRO)


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Art. 23 Assessment, notification and reporting on the use of radiation sources 9

1 In the case of in­vest­ig­a­tions us­ing ra­di­ation sources, the pro­ject lead­er shall as­sess com­pli­ance with the dose guid­ance value un­der Art­icle 45 of the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 26 April 201710.

2 He or she shall give no­ti­fy the com­pet­ent eth­ics com­mit­tee if the per­mit­ted dose guid­ance value with­in sev­en work­ing days of the in­form­a­tion com­ing to light.

3 The com­pet­ent eth­ics com­mit­tee may ob­tain tech­nic­al ad­vice from the FOPH in or­der to as­sess the dose cal­cu­la­tion or the dose es­tim­ate and to de­cide what fur­ther meas­ures are re­quired.

4 With­in a year of com­plet­ing or dis­con­tinu­ing a re­search pro­ject which in­cluded in­vest­ig­a­tions in­volving ra­dio­act­ive sources, the pro­ject lead­er shall sub­mit to the FOPH a fi­nal re­port in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive dose es­tim­a­tion by the par­ti­cipants.

5 Routine nuc­le­ar medi­cine ex­am­in­a­tions in­volving au­thor­ised ra­dio­phar­ma­ceut­ic­als are ex­empt from the re­port­ing re­quire­ment un­der para­graph 4.

6 With­in the frame­work of the opin­ion de­livered in ac­cord­ance with Art­icle 19, or on re­quest, the FOPH may spe­cify fur­ther ex­emp­tions from the re­port­ing re­quire­ments.

9 Amended by An­nex 11 No 5 of the Ra­di­ation Pro­tec­tion Or­din­ance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261).

10 SR 814.501

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