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

¹ The pro­ject lead­er shall sub­mit the ap­plic­a­tion for a mul­ti­centre re­search pro­ject to the lead com­mit­tee in ac­cord­ance with Art­icle 47 para­graph 2 HRA.

² The lead com­mit­tee shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and at the same time no­ti­fy the pro­ject lead­er wheth­er the ap­plic­a­tion doc­u­ments sub­mit­ted are form­ally in or­der.

³ At the re­quest of the lead com­mit­tee, the pro­ject lead­er shall sub­mit the re­quired num­ber of cop­ies of the ap­plic­a­tion doc­u­ments spe­cified in An­nex 2 to the eth­ics com­mit­tees re­spons­ible at the oth­er re­search sites (eth­ics com­mit­tees con­cerned). These shall re­view the loc­al con­di­tions and in­form the lead com­mit­tee of their as­sess­ment with­in 15 days.

⁴ The lead com­mit­tee shall reach a de­cision with­in 45 days of ac­know­ledging re­ceipt of the form­ally cor­rect ap­plic­a­tion. It shall in­form the eth­ics com­mit­tees con­cerned of its de­cision.