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

¹ In ad­di­tion to the points spe­cified in Art­icle 16 para­graph 2 HRA, the per­sons con­cerned must re­ceive in­form­a­tion on:

a.

pos­sible al­tern­at­ives to the in­ter­ven­tion un­der in­vest­ig­a­tion, if the clin­ic­al tri­al is ex­pec­ted to of­fer a dir­ect be­ne­fit;

b.

the ef­fort in­volved and the ob­lig­a­tions arising from par­ti­cip­a­tion;

c.

their right to with­hold or to re­voke their con­sent without giv­ing reas­ons and without suf­fer­ing any dis­ad­vant­ages in re­la­tion to their med­ic­al treat­ment;

d.

the con­sequences of re­voc­a­tion of con­sent for their sub­sequent med­ic­al treat­ment, and for fur­ther use of the per­son­al data and bio­lo­gic­al ma­ter­i­al col­lec­ted up to this point;

e.

their right to re­ceive in­form­a­tion at any time in re­sponse to fur­ther ques­tions re­lat­ing to the clin­ic­al tri­al;

f.

their right to be in­formed of res­ults con­cern­ing their health, and their right to forgo such in­form­a­tion or to des­ig­nate a per­son who is to take this de­cision for them;

g.

the meas­ures en­vis­aged to cov­er any dam­age arising from the clin­ic­al tri­al, in­clud­ing the pro­ced­ure in the event of a claim;

h.

the spon­sor and the main sources of fin­an­cing for the clin­ic­al tri­al;

i.

oth­er points rel­ev­ant to their de­cision on par­ti­cip­a­tion.

² If the in­ten­tion ex­ists to make fur­ther use for re­search of bio­lo­gic­al ma­ter­i­al sampled or health-re­lated per­son­al data col­lec­ted in the clin­ic­al tri­al, the per­sons con­cerned must also re­ceive in­form­a­tion on the points spe­cified in Art­icles 28–32 of the Hu­man Re­search Or­din­ance of 20 Septem­ber 2013²⁰.

³ The in­form­a­tion may be provided in stages. It may be ad­di­tion­ally presen­ted in a non-tex­tu­al form.

⁴ Ap­pro­pri­ate meas­ures must be taken to en­sure that the per­sons con­cerned have un­der­stood the es­sen­tial ele­ments of the in­form­a­tion provided.