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

¹ The spon­sor and the in­vest­ig­at­or must, when plan­ning or con­duct­ing a clin­ic­al tri­al in an emer­gency situ­ation, take any meas­ures ne­ces­sary to en­sure that:

a.

the con­sent of the per­son con­cerned can be ob­tained post hoc as soon as pos­sible;

b.

in the case of a clin­ic­al tri­al in­volving chil­dren or ad­oles­cents, the con­sent of the leg­al rep­res­ent­at­ive can be ob­tained as soon as pos­sible, if this is re­quired in ac­cord­ance with Art­icles 22 and 23 HRA;

c.

in the case of a clin­ic­al tri­al in­volving adults per­man­ently lack­ing ca­pa­city, the con­sent of the per­son au­thor­ised to act as a rep­res­ent­at­ive can be ob­tained as soon as pos­sible, if no state­ment of wishes for­mu­lated in a state of ca­pa­city is avail­able.

² The pro­ced­ure for ob­tain­ing post hoc con­sent must be defined in the pro­tocol.