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

This Or­din­ance reg­u­lates:

a.

the re­quire­ments for the con­duct of hu­man re­search pro­jects with the ex­cep­tion of clin­ic­al tri­als; and

b.

the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures for re­search pro­jects as spe­cified in let­ter a.

The pro­vi­sions con­cern­ing sci­entif­ic in­teg­rity and sci­entif­ic qual­ity set out in Art­icles 3 and 4 of the Or­din­ance of 20 Septem­ber 2013² on Clin­ic­al Tri­als (ClinO) ap­ply mu­tatis mutandis.

¹ The pro­ject lead­er is re­spons­ible for the con­duct of the re­search pro­ject in Switzer­land and for pro­tec­tion of the par­ti­cipants at the re­search site.

² The pro­ject lead­er is also re­spons­ible for or­gan­ising the re­search pro­ject, and in par­tic­u­lar for the ini­ti­ation, man­age­ment and fin­an­cing of the pro­ject in Switzer­land, provided that no oth­er per­son or in­sti­tu­tion headquartered or rep­res­en­ted in Switzer­land takes re­spons­ib­il­ity for this (spon­sor).

¹ The pro­ject lead­er re­spons­ible for a re­search pro­ject must:

a.

be en­titled to prac­tise in­de­pend­ently the pro­fes­sion spe­cific­ally qual­i­fy­ing him or her to con­duct the re­search pro­ject in ques­tion;

b.

have the train­ing and ex­per­i­ence re­quired to con­duct the re­search pro­ject in ques­tion;

c.

be con­vers­ant with the leg­al re­quire­ments for re­search pro­jects or be able to en­sure com­pli­ance by call­ing in ap­pro­pri­ate ex­pert­ise.

² The oth­er per­sons con­duct­ing the re­search pro­ject must have the pro­fes­sion­al know­ledge and ex­per­i­ence ap­pro­pri­ate to the activ­it­ies in ques­tion.

¹ Any per­son who stores health-re­lated per­son­al data for re­search must take ap­pro­pri­ate op­er­a­tion­al and or­gan­isa­tion­al meas­ures to pro­tect it, and in par­tic­u­lar:

a.

re­strict the hand­ling of the health-re­lated per­son­al data to those per­sons who re­quire this data to ful­fil their du­ties;

b.

pre­vent un­au­thor­ised or ac­ci­dent­al dis­clos­ure, al­ter­a­tion, de­le­tion and copy­ing of the health-re­lated per­son­al data;

c.

doc­u­ment all pro­cessing op­er­a­tions which are es­sen­tial to en­sure trace­ab­il­ity.

² Any per­son who stores bio­lo­gic­al ma­ter­i­al for re­search must, in par­tic­u­lar:

a.

com­ply with the prin­ciples set out in para­graph 1 mu­tatis mutandis;

b.

en­sure that the tech­nic­al re­quire­ments are met for ap­pro­pri­ate stor­age of the bio­lo­gic­al ma­ter­i­al;

c.

make avail­able the re­sources re­quired for stor­age.

For the pur­poses of this Chapter, a re­search pro­ject is any pro­ject in which bio­lo­gic­al ma­ter­i­al is sampled or health-re­lated per­son­al data is col­lec­ted from a per­son in or­der to:

a.

an­swer a sci­entif­ic ques­tion; or

b.

make fur­ther use for re­search pur­poses of the bio­lo­gic­al ma­ter­i­al or the health-re­lated per­son­al data.

¹ A re­search pro­ject comes un­der Cat­egory A if the planned meas­ures for sampling bio­lo­gic­al ma­ter­i­al or col­lect­ing per­son­al data en­tail only min­im­al risks and bur­dens.

² A re­search pro­ject comes un­der Cat­egory B if the planned meas­ures en­tail more than only min­im­al risks and bur­dens.

³ Sampling bio­lo­gic­al ma­ter­i­al or col­lect­ing health-re­lated per­son­al data en­tails min­im­al risks and bur­dens if the meas­ures, in terms of in­tens­ity and qual­ity, and tak­ing in­to ac­count the vul­ner­ab­il­ity of the par­ti­cipants and the spe­cif­ic cir­cum­stances, have only a slight and tem­por­ary im­pact on the par­ti­cipants’ health. In par­tic­u­lar, min­im­al risks and bur­dens may be as­so­ci­ated with:

a.

sur­veys and ob­ser­va­tions;

b.

peri­pher­al ven­ous or ca­pil­lary blood sampling and skin punch biopsies of lim­ited ex­tent;

c.

re­mov­ing or col­lect­ing bod­ily sub­stances without in­vas­ive in­ter­ven­tions (in par­tic­u­lar, saliva, ur­ine and stool samples);

d.

tak­ing swabs;

e.

mag­net­ic res­on­ance ima­ging scans without a con­trast me­di­um, ul­tra­sound ex­am­in­a­tions or elec­tro­grams;

f.³

ex­am­in­a­tions us­ing ion­ising ra­di­ation, provided that the ef­fect­ive dose is be­low 5 mSv per re­search pro­ject and per per­son con­cerned and:

1.

the medi­cin­al product used is au­thor­ised or ex­empt from au­thor­isa­tion, or

2.

the devices un­der Art­icle 1 of the Med­ic­al Devices Or­din­ance of 1 Ju­ly 2020⁴ bear con­form­ity mark­ings and no con­trast me­di­um is used.

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

a.

the ef­fort in­volved and the ob­lig­a­tions arising from par­ti­cip­a­tion;

b.

their right to with­hold or to re­voke their con­sent without giv­ing reas­ons;

c.

the con­sequences of re­vok­ing con­sent to fur­ther use of the bio­lo­gic­al ma­ter­i­al and per­son­al data col­lec­ted up to this point;

d.

their right to re­ceive in­form­a­tion at any time in re­sponse to fur­ther ques­tions;

e.

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;

f.

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

g.

the main sources of fin­an­cing for the re­search pro­ject;

h.

oth­er points rel­ev­ant to their de­cision on par­ti­cip­a­tion.

² If the in­ten­tion ex­ists to make fur­ther use for re­search of the bio­lo­gic­al ma­ter­i­al sampled or the health-re­lated per­son­al data col­lec­ted, the per­sons con­cerned must also re­ceive in­form­a­tion on the points spe­cified in Art­icles 28−32.

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.

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.

¹ If con­sent is re­voked, the bio­lo­gic­al ma­ter­i­al and health‑re­lated per­son­al data of the per­son con­cerned must be an­onymised after data eval­u­ation has been com­pleted.

² An­onymisa­tion of the bio­lo­gic­al ma­ter­i­al and per­son­al data may be dis­pensed with if:

a.

the per­son con­cerned ex­pressly re­nounces this right when re­vok­ing con­sent; or

b.

it is es­tab­lished at the be­gin­ning of the re­search pro­ject that an­onymisa­tion is not pos­sible and the per­son con­cerned, hav­ing been ad­equately in­formed of this fact, con­sen­ted to par­ti­cip­ate.

³ Per­sons re­vok­ing con­sent must be offered any fol­low-up care re­quired to pro­tect their health.

For re­search pro­jects in emer­gency situ­ations, Art­icles 15–17 ClinO⁵ ap­ply mu­tatis mutandis.

Any per­son who proves that:

a.

the dam­age is only slight and tem­por­ary; and

b.

the ex­tent of the dam­age is no great­er than would be ex­pec­ted in the cur­rent state of sci­entif­ic know­ledge

shall be ex­empt from li­ab­il­ity un­der Art­icle 19 para­graph 1 HRA.

¹ Cat­egory A re­search pro­jects are ex­empt from the li­ab­il­ity cov­er­age re­quire­ments spe­cified in Art­icle 20 HRA.

² For Cat­egory B re­search pro­jects, the policy value shall be set in ac­cord­ance with An­nex 1.

³ The li­ab­il­ity cov­er­age must cov­er dam­age oc­cur­ring up to 10 years after the com­ple­tion of the re­search pro­ject.

⁴ In ad­di­tion, Art­icle 11, Art­icle 13 para­graph 1 and Art­icle 14 ClinO⁶ ap­ply mu­tatis mutandis.

¹ The pro­ject lead­er shall sub­mit the ap­plic­a­tion doc­u­ments spe­cified in An­nex 2 to the re­spons­ible eth­ics com­mit­tee for re­view.

² The eth­ics com­mit­tee may re­quest ad­di­tion­al in­form­a­tion.

³ The spon­sor may sub­mit the ap­plic­a­tion in­stead of the pro­ject lead­er. In this case, the spon­sor as­sumes the ob­lig­a­tions of the pro­ject lead­er as spe­cified in Art­icles 17–23. The ap­plic­a­tion doc­u­ments must be co-signed by the pro­ject lead­er.

The re­spons­ible eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the cat­egor­isa­tion re­ques­ted;

c.

the re­search pro­ject with re­gard to:

1.

sci­entif­ic qual­ity, in the case of a re­search pro­ject as spe­cified in Art­icle 6 let­ter a,

2.

the ra­tio between the likely risks and bur­dens and the ex­pec­ted be­ne­fits (Art. 12 para. 2 HRA),

3.

the meas­ures taken to min­im­ise risks and bur­dens, and for the pro­tec­tion and fol­low-up of par­ti­cipants (Art. 15 HRA), in­clud­ing pre­cau­tion­ary meas­ures in the hand­ling of per­son­al data,

4.

the need to in­volve per­sons, and in par­tic­u­lar per­sons who are par­tic­u­larly vul­ner­able (Art. 11 HRA),

5.

the cri­ter­ia for the se­lec­tion of par­ti­cipants,

6.

the pro­posed pro­ced­ure for provid­ing in­form­a­tion and ob­tain­ing con­sent, in­clud­ing the ap­pro­pri­ate­ness of the peri­od for re­flec­tion,

7.

the ap­pro­pri­ate­ness of the re­mu­ner­a­tion for par­ti­cipants and com­pli­ance with the pro­hib­i­tion of com­mer­cial­isa­tion (Art. 9 HRA),

8.

com­pli­ance with sci­entif­ic in­teg­rity re­quire­ments;

d.

the com­plete­ness of the doc­u­ment­a­tion for re­cruit­ment, in­form­a­tion and con­sent, and its com­pre­hens­ib­il­ity, es­pe­cially with re­gard to the pos­sible in­volve­ment of par­tic­u­larly vul­ner­able per­sons;

e.

for Cat­egory B re­search pro­jects: the guar­an­tee­ing of the right to com­pens­a­tion in the event of dam­age (Art. 20 HRA);

f.

for in­vest­ig­a­tions in­volving ra­di­ation sources⁷: ad­di­tion­ally, com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion, in cases where an opin­ion does not have to be sought from the Fed­er­al Of­fice of Pub­lic Health (FOPH) in ac­cord­ance with Art­icle 19 para­graph 2;

g.

the pro­fes­sion­al qual­i­fic­a­tions of the pro­ject lead­er and the oth­er re­search­ers;

h.

com­pli­ance with the re­quire­ments con­cern­ing the stor­age of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data spe­cified in Art­icle 5;

i.

the suit­ab­il­ity of the in­fra­struc­ture at the re­search site;

j.

the fin­an­cing of the re­search pro­ject and the agree­ments between the spon­sor, third parties and the pro­ject lead­er con­cern­ing the al­loc­a­tion of tasks, re­mu­ner­a­tion and pub­lic­a­tion;

k.

oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of par­ti­cipants.

¹ The eth­ics com­mit­tee shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and no­ti­fy the pro­ject lead­er of any form­al de­fi­cien­cies in the ap­plic­a­tion doc­u­ments.

² It shall reach a de­cision with­in 30 days after ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

³ If the eth­ics com­mit­tee re­quests ad­di­tion­al in­form­a­tion in ac­cord­ance with Art­icle 14 para­graph 2, the clock shall be stopped un­til this in­form­a­tion has been re­ceived.

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.

¹ Sig­ni­fic­ant changes to an au­thor­ised re­search pro­ject must be au­thor­ised by the eth­ics com­mit­tee be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The pro­ject lead­er shall sub­mit to the eth­ics com­mit­tee any ap­plic­a­tion doc­u­ments spe­cified in An­nex 2 which are af­fected by the change. At the same time, the pro­ject lead­er shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

changes af­fect­ing the par­ti­cipants’ safety and health, or their rights and ob­lig­a­tions;

b.

in the case of a Cat­egory B re­search pro­ject, changes to the pro­tocol which con­cern the goal or the cent­ral top­ic of the re­search pro­ject;

c.

a change of re­search site or con­duct­ing the re­search pro­ject at an ad­di­tion­al site; or

d.

a change of pro­ject lead­er or spon­sor.

⁴ The eth­ics com­mit­tee shall reach a de­cision on sig­ni­fic­ant changes with­in 30 days. Art­icle 16 ap­plies mu­tatis mutandis.

⁵ For the au­thor­isa­tion pro­ced­ure in the case of sig­ni­fic­ant changes to au­thor­ised mul­ti­centre re­search pro­jects, Art­icle 17 ap­plies mu­tatis mutandis.

¹ In the case of in­vest­ig­a­tions in­volving ra­di­ation sources, the pro­ject lead­er shall ad­di­tion­ally sub­mit to the re­spons­ible eth­ics com­mit­tee the doc­u­ments spe­cified in An­nex 2 num­ber 2. Sub­ject to the pro­vi­sions of the fol­low­ing para­graphs, the au­thor­isa­tion pro­ced­ure is gov­erned by Art­icles 14–18.

² The pro­ject lead­er shall ad­di­tion­ally sub­mit to the FOPH the ap­plic­a­tion doc­u­ments spe­cified in An­nex 2 num­ber 3, in­form­ing the eth­ics com­mit­tee at the same time if the ef­fect­ive dose per per­son, tak­ing the un­cer­tainty factor in­to ac­count, is more than 5 mSv per year and:

a.

a ra­dio­phar­ma­ceut­ic­al is used which is not au­thor­ised in Switzer­land;

b.

a ra­dio­phar­ma­ceut­ic­al is used which is au­thor­ised in Switzer­land, and the in­ter­ven­tion in ques­tion is not a routine nuc­le­ar medi­cine ex­am­in­a­tion; or

c.

some oth­er ra­dio­act­ive source⁸ is used.

³ The FOPH shall de­liv­er an opin­ion for the eth­ics com­mit­tee on com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and on the dose es­tim­a­tion.

⁴ The eth­ics com­mit­tee shall grant au­thor­isa­tion if:

a.

the re­quire­ments covered by Art­icle 15 are met; and

b.

the FOPH has raised no ob­jec­tions to the re­search pro­ject.

⁵ It shall reach a de­cision in this case with­in 45 days after ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. It shall in­form the FOPH of its de­cision.

If im­me­di­ate safety and pro­tect­ive meas­ures have to be taken dur­ing the con­duct of a re­search pro­ject, the pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of these meas­ures, and of the cir­cum­stances ne­ces­sit­at­ing them, with­in 7 days.

¹ If, in the course of a re­search pro­ject, ser­i­ous events oc­cur in par­ti­cipants, the re­search pro­ject must be in­ter­rup­ted.

² A ser­i­ous event is defined as any ad­verse event where it can­not be ex­cluded that the event is at­trib­ut­able to the sampling of bio­lo­gic­al ma­ter­i­al or the col­lec­tion of health-re­lated per­son­al data, and which:

a.

re­quires in­pa­tient treat­ment not en­vis­aged in the pro­tocol or ex­tends a cur­rent hos­pit­al stay;

b.

res­ults in per­man­ent or sig­ni­fic­ant in­ca­pa­city or dis­ab­il­ity; or

c.

is life-threat­en­ing or res­ults in death.

³ If ne­ces­sary in or­der to guar­an­tee par­ti­cipants’ safety and health, fur­ther events are to be des­ig­nated as ser­i­ous in the pro­tocol or at the re­quest of the re­spons­ible eth­ics com­mit­tee.

⁴ The pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of a ser­i­ous event with­in 7 days. In ad­di­tion, the pro­ject lead­er shall re­port to the com­mit­tee on the con­nec­tion between the event and the col­lec­tion of health-re­lated per­son­al data or the sampling of bio­lo­gic­al ma­ter­i­al. At the same time, he or she shall sub­mit pro­pos­als con­cern­ing the next steps to be taken.

⁵ If a ser­i­ous event oc­curs in con­nec­tion with an in­vest­ig­a­tion in­volving a ra­di­ation source on which the FOPH has de­livered an opin­ion in ac­cord­ance with Art­icle 19, this must be ad­di­tion­ally re­por­ted to the FOPH with­in 7 days.

⁶ The eth­ics com­mit­tee shall reach a de­cision on the con­tinu­ation of the re­search pro­ject with­in 30 days after re­ceipt of the re­port.

The pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of the dis­con­tinu­ation or com­ple­tion of a re­search pro­ject with­in 90 days.

¹ In the case of in­vest­ig­a­tions us­ing ra­di­ation sources, the pro­ject lead­er shall as­sess com­pli­ance with the dose guid­ance value un­der Art­icle 45 of the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 26 April 2017¹⁰.

² He or she shall give no­ti­fy the com­pet­ent eth­ics com­mit­tee if the per­mit­ted dose guid­ance value with­in sev­en work­ing days of the in­form­a­tion com­ing to light.

³ The com­pet­ent eth­ics com­mit­tee may ob­tain tech­nic­al ad­vice from the FOPH in or­der to as­sess the dose cal­cu­la­tion or the dose es­tim­ate and to de­cide what fur­ther meas­ures are re­quired.

⁴ With­in a year of com­plet­ing or dis­con­tinu­ing a re­search pro­ject which in­cluded in­vest­ig­a­tions in­volving ra­dio­act­ive sources, the pro­ject lead­er shall sub­mit to the FOPH a fi­nal re­port in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive dose es­tim­a­tion by the par­ti­cipants.

⁵ Routine nuc­le­ar medi­cine ex­am­in­a­tions in­volving au­thor­ised ra­dio­phar­ma­ceut­ic­als are ex­empt from the re­port­ing re­quire­ment un­der para­graph 4.

⁶ With­in the frame­work of the opin­ion de­livered in ac­cord­ance with Art­icle 19, or on re­quest, the FOPH may spe­cify fur­ther ex­emp­tions from the re­port­ing re­quire­ments.

Fur­ther use of bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data is defined as any hand­ling, for re­search pur­poses, of bio­lo­gic­al ma­ter­i­al already sampled or data already col­lec­ted, and in par­tic­u­lar:

a.

pro­cur­ing, bring­ing to­geth­er or col­lect­ing bio­lo­gic­al ma­ter­i­al or health‑re­lated per­son­al data;

b.

re­gis­tra­tion or cata­loguing of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data;

c.

stor­age or in­clu­sion in biobanks or data­bases;

d.

mak­ing ac­cess­ible or avail­able or trans­fer­ring bio­lo­gic­al ma­ter­i­al or health‑re­lated per­son­al data.

¹ For the an­onymisa­tion of bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data, all items which, when com­bined, would en­able the data sub­ject to be iden­ti­fied without dis­pro­por­tion­ate ef­fort, must be ir­re­vers­ibly masked or de­leted.

² In par­tic­u­lar, the name, ad­dress, date of birth and unique iden­ti­fic­a­tion num­bers must be masked or de­leted.

¹ Bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data are con­sidered to be cor­rectly coded in ac­cord­ance with Art­icle 32 para­graph 2 and Art­icle 33 para­graph 2 HRA if, from the per­spect­ive of a per­son who lacks ac­cess to the key, they are to be char­ac­ter­ised as an­onymised.

² The key must be stored sep­ar­ately from the bio­lo­gic­al ma­ter­i­al or per­son­al data and in ac­cord­ance with the prin­ciples of Art­icle 5 para­graph 1, by a per­son to be des­ig­nated in the ap­plic­a­tion who is not in­volved in the re­search pro­ject.¹¹

For coded bio­lo­gic­al ma­ter­i­al and coded health-re­lated per­son­al data, the code may only be broken if:

a.

break­ing the code is ne­ces­sary to avert an im­me­di­ate risk to the health of the per­son con­cerned;

b.

a leg­al basis ex­ists for break­ing the code; or

c.

break­ing the code is ne­ces­sary to guar­an­tee the rights of the per­son con­cerned, and in par­tic­u­lar the right to re­voke con­sent.

¹ The per­sons con­cerned must re­ceive writ­ten and or­al in­form­a­tion on:

a.

the nature, pur­pose and dur­a­tion of, and pro­ced­ure for, the re­search pro­ject;

b.

their right to with­hold or to re­voke their con­sent at any time without giv­ing reas­ons;

c.

the con­sequences of re­voc­a­tion of con­sent for the bio­lo­gic­al ma­ter­i­al and per­son­al data used up to this point;

d.

their right to re­ceive in­form­a­tion at any time in re­sponse to fur­ther ques­tions re­lat­ing to the re­search pro­ject;

e.

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;

f.

meas­ures to pro­tect the bio­lo­gic­al ma­ter­i­al and the per­son­al data;

g.

the main sources of fin­an­cing for the re­search pro­ject;

h.

oth­er points rel­ev­ant to their de­cision.

² The in­form­a­tion may be ad­di­tion­ally presen­ted in a non-tex­tu­al form.

³ Con­sent must be giv­en in writ­ing.

⁴ The ex­cep­tions to writ­ten form are gov­erned by Art­icle 9 mu­tatis mutandis.

¹ The per­sons con­cerned must re­ceive writ­ten or or­al in­form­a­tion on:

a.

the pro­posed fur­ther use of the coded bio­lo­gic­al ma­ter­i­al and coded ge­net­ic per­son­al data for re­search pur­poses;

b.

their right to with­hold or to re­voke their con­sent at any time without giv­ing reas­ons;

c.

meas­ures to pro­tect the bio­lo­gic­al ma­ter­i­al and per­son­al data, and in par­tic­u­lar man­age­ment of the key;

d.

the pos­sib­il­ity of the bio­lo­gic­al ma­ter­i­al and the ge­net­ic per­son­al data be­ing passed on to third parties for re­search pur­poses.

² Con­sent must be giv­en in writ­ing; the ex­cep­tions are gov­erned by Art­icle 9 mu­tatis mutandis.

The per­sons con­cerned must re­ceive writ­ten or or­al in­form­a­tion on:

a.

the pro­posed an­onymisa­tion of the bio­lo­gic­al ma­ter­i­al and ge­net­ic per­son­al data for re­search pur­poses;

b.

their right to dis­sent;

c.

the con­sequences of an­onymisa­tion with re­gard to res­ults con­cern­ing their health;

d.

the pos­sib­il­ity of the bio­lo­gic­al ma­ter­i­al and the data be­ing passed on to third parties for re­search pur­poses.

¹ The per­sons con­cerned must re­ceive writ­ten or or­al in­form­a­tion on:

a.

the pro­posed fur­ther use of the non-ge­net­ic health-re­lated per­son­al data for re­search pur­poses;

b.

their right to with­hold or to re­voke their con­sent at any time without giv­ing reas­ons;

c.

their right to be in­formed of res­ults con­cern­ing their health, and their right to forgo such in­form­a­tion;

d.

meas­ures to pro­tect the per­son­al data;

e.

the pos­sib­il­ity of the per­son­al data be­ing passed on to third parties for re­search pur­poses.

² Con­sent must be giv­en in writ­ing; the ex­cep­tions are gov­erned by Art­icle 9 mu­tatis mutandis.

The per­sons con­cerned must re­ceive writ­ten or or­al in­form­a­tion on:

a.

the pro­posed fur­ther use of the non-ge­net­ic health-re­lated per­son­al data in coded form for re­search pur­poses;

b.

their right to dis­sent;

c.

meas­ures to pro­tect the per­son­al data, and in par­tic­u­lar man­age­ment of the key;

d.

the pos­sib­il­ity of the per­son­al data be­ing passed on to third parties for re­search pur­poses.

For the pur­poses of this Sec­tion, a re­search pro­ject is any pro­ject in which fur­ther use is made of bio­lo­gic­al ma­ter­i­al already sampled or health-re­lated per­son­al data already col­lec­ted in or­der to an­swer a sci­entif­ic ques­tion.

¹ The eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the ful­fil­ment of the con­di­tions spe­cified in Art­icles 32 and 33 HRA;

c.

for re­search pro­jects in­volving bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data in coded form: cor­rect and se­cure cod­ing;

d.

com­pli­ance with the re­quire­ments for the stor­age of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data;

e.

the pro­fes­sion­al qual­i­fic­a­tions of the pro­ject lead­er and the oth­er per­sons in­volved in the re­search pro­ject;

f.

oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of the per­sons con­cerned.

² In this pro­cess, it shall take in­to ac­count ex­ist­ing au­thor­isa­tions from eth­ics com­mit­tees with re­gard to the bio­lo­gic­al ma­ter­i­al or the health-re­lated per­son­al data.

The fol­low­ing pro­vi­sions ap­ply mu­tatis mutandis:

a.

for the sub­mis­sion of the ap­plic­a­tion: Art­icle 14;

b.

for the pro­ced­ure and dead­lines: Art­icle 16;

c.

for mul­ti­centre re­search pro­jects: Art­icle 17.

¹ The pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of a change of pro­ject lead­er in ad­vance.

² The pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of the com­ple­tion or dis­con­tinu­ation of the re­search pro­ject with­in 90 days.

The eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the reas­ons, as spe­cified in Art­icle 34 let­ters a and b HRA;

c.

the in­terests of the pro­posed re­search which out­weigh the in­terests of the per­son con­cerned in de­cid­ing on the fur­ther use of his or her bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data;

d.

the group of per­sons en­titled to pass on the bio­lo­gic­al ma­ter­i­al and the per­son­al data;

e.

com­pli­ance with the re­quire­ments con­cern­ing the stor­age of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data and the group of per­sons with ac­cess rights;

f.

the pro­fes­sion­al qual­i­fic­a­tions of the per­sons en­titled to re­ceive the bio­lo­gic­al ma­ter­i­al and the per­son­al data;

g.

oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of the per­sons con­cerned.

The fol­low­ing pro­vi­sions ap­ply mu­tatis mutandis:

a.

for the sub­mis­sion of the ap­plic­a­tion: Art­icle 14;

b.

for the pro­ced­ure and dead­lines: Art­icle 16;

c.

for fur­ther use or col­lec­tion ac­cord­ing to a stand­ard pro­tocol, but in dif­fer­ent can­tons: the pro­ced­ure spe­cified in Art­icle 17.

The au­thor­isa­tion shall in­clude at least the fol­low­ing in­form­a­tion:

a.

the pur­pose for which fur­ther use may be made of the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data;

b.

the des­ig­na­tion of the bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data covered by the au­thor­isa­tion;

c.

the group of per­sons en­titled to pass on the bio­lo­gic­al ma­ter­i­al and the health-re­lated per­son­al data;

d.

the group of per­sons en­titled to re­ceive the bio­lo­gic­al ma­ter­i­al and the per­son­al data.

¹ The pro­ject lead­er must no­ti­fy the eth­ics com­mit­tee in ad­vance of any changes to the in­form­a­tion giv­en in the au­thor­isa­tion.

² The pro­ject lead­er must no­ti­fy the eth­ics com­mit­tee of the com­ple­tion or dis­con­tinu­ation of the col­lec­tion pro­cess with­in 90 days.

The eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the sci­entif­ic qual­ity;

c.

com­pli­ance with the re­quire­ments for con­sent (Art. 36 HRA);

d.

for re­search pro­jects in­volving de­ceased per­sons un­der­go­ing ar­ti­fi­cial res­pir­a­tion: the need to in­volve them in the re­search pro­ject (Art. 37 para. 2 HRA) and com­pli­ance with the re­quire­ment for in­de­pend­ence of the per­sons in­volved in the de­term­in­a­tion of their death (Art. 37 para. 3 HRA);

e.

com­pli­ance with the re­quire­ments for the stor­age of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data;

f.

com­pli­ance with the pro­hib­i­tion of com­mer­cial­isa­tion (Art. 9 HRA);

g.

the pro­fes­sion­al qual­i­fic­a­tions of the pro­ject lead­er and the oth­er re­search­ers.

The fol­low­ing pro­vi­sions ap­ply mu­tatis mutandis:

a.

for the sub­mis­sion of the ap­plic­a­tion: Art­icle 14;

b.

for the pro­ced­ure and dead­lines: Art­icle 16;

c.

for mul­ti­centre re­search pro­jects: the pro­ced­ure spe­cified in Art­icle 17.

¹ The pro­ject lead­er must no­ti­fy the eth­ics com­mit­tee in ad­vance of the fol­low­ing changes to the re­search pro­ject:

a.

change of pro­ject lead­er;

b.

for re­search pro­jects in­volving de­ceased per­sons un­der­go­ing ar­ti­fi­cial res­pir­a­tion: sig­ni­fic­ant changes to the pro­tocol.

² The pro­ject lead­er shall no­ti­fy the eth­ics com­mit­tee of the com­ple­tion or dis­con­tinu­ation of the re­search pro­ject with­in 90 days.

¹ For re­search pro­jects in­volving em­bry­os and foetuses from in­duced abor­tions and from spon­tan­eous abor­tions in­clud­ing still­births, the preg­nant wo­man or the couple con­cerned must re­ceive writ­ten and or­al in­form­a­tion on:

a.

the use of the em­bryo or foetus for re­search pur­poses;

b.

their right to with­hold or to re­voke their con­sent at any time without giv­ing reas­ons;

c.

meas­ures to pro­tect the bio­lo­gic­al ma­ter­i­al and the per­son­al data;

d.

the hand­ling of the em­bryo or foetus after com­ple­tion of the re­search.

² The in­form­a­tion may be ad­di­tion­ally presen­ted in a non-tex­tu­al form.

³ Con­sent must be giv­en in writ­ing. The con­sequences of re­voc­a­tion of con­sent are gov­erned by Art­icle 10.

⁴ The ex­cep­tions to writ­ten form are gov­erned by Art­icle 9 mu­tatis mutandis.

The eth­ics com­mit­tee shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the sci­entif­ic qual­ity;

c.

com­pli­ance with the re­quire­ments for in­formed con­sent;

d.

for re­search pro­jects in­volving em­bry­os and foetuses from in­duced abor­tions: com­pli­ance with the re­quire­ments spe­cified in Art­icle 39 para­graphs 1, 2 and 4 HRA;

e.

com­pli­ance with the pro­hib­i­tion of com­mer­cial­isa­tion (Art. 9 HRA);

f.

com­pli­ance with the re­quire­ments con­cern­ing the stor­age of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data;

g.

the pro­fes­sion­al qual­i­fic­a­tions of the pro­ject lead­er and the oth­er re­search­ers;

h.

oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of the preg­nant wo­man or the couple con­cerned.

The fol­low­ing pro­vi­sions ap­ply mu­tatis mutandis:

a.

for the sub­mis­sion of the ap­plic­a­tion: Art­icle 14;

b.

for the pro­ced­ure and dead­lines: Art­icle 16;

c.

for mul­ti­centre re­search pro­jects: the pro­ced­ure spe­cified in Art­icle 17;

d.

for no­ti­fic­a­tion re­quire­ments: Art­icle 36.

The Fed­er­al De­part­ment of Home Af­fairs may up­date the An­nexes in ac­cord­ance with in­ter­na­tion­al or tech­nic­al de­vel­op­ments. It shall un­der­take up­dates which may give rise to tech­nic­al bar­ri­ers to trade in con­sulta­tion with the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search.

¹ Re­search pro­jects as defined in Chapter 2 which were gran­ted au­thor­isa­tion be­fore 1 Janu­ary 2014 are con­sidered to be Cat­egory B re­search pro­jects.

² On re­quest, the au­thor­ity which au­thor­ised the re­search pro­ject be­fore 1 Janu­ary 2014 may as­sign the re­search pro­ject to Cat­egory A. In this case, the li­ab­il­ity, cov­er­age and no­ti­fic­a­tion re­quire­ments are gov­erned by the new law.

³ The eth­ics com­mit­tee shall make the de­cision spe­cified in para­graph 2 ac­cord­ing to the sim­pli­fied pro­ced­ure spe­cified in Art­icle 6 of the HRA Or­gan­isa­tion Or­din­ance of 20 Septem­ber 2013¹².

⁴ The pro­vi­sions of this Or­din­ance are ap­plic­able:

a.

to the as­sess­ment of sig­ni­fic­ant changes to re­search pro­jects as spe­cified in Chapter 2;

b.

to no­ti­fic­a­tions con­cern­ing re­search pro­jects as spe­cified in Chapters 3–5.

⁵ The re­spons­ible eth­ics com­mit­tee shall make a de­cision on ap­plic­a­tions con­cern­ing re­search pro­jects not sub­ject to au­thor­isa­tion un­der ex­ist­ing law, sub­mit­ted in ac­cord­ance with Art­icle 67 para­graph 2 HRA, with­in six months after ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

This Or­din­ance comes in­to force on 1 Janu­ary 2014.