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

¹ The bio­lo­gic­al ma­ter­i­al sampled and the health-re­lated per­son­al data col­lec­ted dur­ing a clin­ic­al tri­al in an emer­gency situ­ation may only be eval­u­ated when con­sent has been ob­tained in ac­cord­ance with Art­icle 15 or 16.

² In ex­cep­tion­al cases, the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data may be eval­u­ated be­fore con­sent has been ob­tained if:

a.

the bio­lo­gic­al ma­ter­i­al is only util­is­able for a lim­ited peri­od; or

b.

this is ne­ces­sary for the sake of the par­ti­cipants’ safety and health.

³ If con­sent to par­ti­cip­ate in a clin­ic­al tri­al in an emer­gency situ­ation is with­held post hoc, the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data must be des­troyed.

⁴ If the valid­ity of the clin­ic­al tri­al or its res­ults is com­prom­ised in es­sen­tial re­spects by the de­struc­tion of the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data, the use there­of in the clin­ic­al tri­al is per­miss­ible in spite of re­fus­al of con­sent. The bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data must be an­onymised without delay. The right to dis­sent of the per­son con­cerned is re­served.

⁵ If it is fore­see­able that ma­ter­i­al or data may be eval­u­ated be­fore con­sent has been ob­tained, in ac­cord­ance with para­graph 2, or used in spite of re­fus­al of con­sent, in ac­cord­ance with para­graph 4, this must be stated in the pro­tocol.