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

¹ In­form­a­tion and con­sent may be provided and doc­u­mented in a non‑writ­ten form if:

a.

the re­search pro­ject in ques­tion comes un­der Cat­egory A, as defined in this Or­din­ance, and in­volves adults with ca­pa­city;

b.

pro­vi­sion of writ­ten in­form­a­tion and con­sent would be dis­pro­por­tion­ate, giv­en the pro­ject design; and

c.

ref­er­ence is made to the de­par­ture from writ­ten form in the ap­plic­a­tion to the re­spons­ible re­search eth­ics com­mit­tee (eth­ics com­mit­tee).

² In in­di­vidu­al cases, in­form­a­tion may be provided and con­sent gran­ted in a non‑writ­ten form if:

a.

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

b.

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

³ 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.