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

¹ In in­di­vidu­al cases, in­form­a­tion may be provided and con­sent giv­en in a non‑writ­ten form if:

a.

the per­son con­cerned, for phys­ic­al or cog­nit­ive reas­ons, can­not read or can­not write; and

b.

the in­vest­ig­at­or fur­nishes proof of the pro­vi­sion of in­form­a­tion and con­sent, spe­cific­ally by means of writ­ten con­firm­a­tion by wit­nesses, or by a re­cord­ing of verbal con­sent.

² In in­di­vidu­al cases, the re­quire­ment to provide in­form­a­tion in writ­ten form may be waived if:

a.

this could only be im­ple­men­ted with dis­pro­por­tion­ate ef­fort, giv­en the lan­guage skills of the per­son con­cerned; and

b.

an in­de­pend­ent qual­i­fied trans­lat­or is called in to provide or­al in­form­a­tion and gives writ­ten con­firm­a­tion there­of.