Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ The right of the per­sons con­cerned to re­ceive in­form­a­tion as spe­cified in Art­icle 8 para­graph 1 HRA ap­plies to res­ults con­cern­ing their health ob­tained by means of tests meet­ing cur­rent stand­ards of ana­lyt­ic­al and clin­ic­al valid­ity.

² Res­ults must be com­mu­nic­ated to the per­sons con­cerned or, where ap­plic­able, to their leg­al rep­res­ent­at­ive, des­ig­nated trus­ted per­son or the next of kin (Art. 22–24 HRA) in cases where:

a.

the res­ults are sub­ject to a leg­al no­ti­fic­a­tion re­quire­ment which stip­u­lates or in­volves in­form­ing the per­son con­cerned about the res­ult;

b.

the res­ults may en­tail a pub­lic health meas­ure which stip­u­lates or in­volves in­form­ing the per­son con­cerned about the res­ult;

c.

the res­ults must be noted by the per­son who is to be in­formed, in or­der to pro­tect the life and health of third parties or of the per­son lack­ing ca­pa­city con­cerned by the test.