Federal Act
on Research involving Human Beings
(Human Research Act, HRA)

¹ The pur­pose of this Act is to pro­tect the dig­nity, pri­vacy and health of hu­man be­ings in­volved in re­search.

² It is also de­signed to:

a.

cre­ate fa­vour­able con­di­tions for re­search in­volving hu­man be­ings;

b.

help to en­sure the qual­ity of re­search in­volving hu­man be­ings;

c.

en­sure the trans­par­ency of re­search in­volving hu­man be­ings.

¹ This Act ap­plies to re­search con­cern­ing hu­man dis­eases and con­cern­ing the struc­ture and func­tion of the hu­man body, which in­volves:

a.

per­sons;

b.

de­ceased per­sons;

c.

em­bry­os and foetuses;

d.

bio­lo­gic­al ma­ter­i­al;

e.

health-re­lated per­son­al data.

² It does not ap­ply to re­search which in­volves:

a.

IVF em­bry­os in ac­cord­ance with the Stem Cell Re­search Act of 19 Decem­ber 2003³;

b.

an­onymised bio­lo­gic­al ma­ter­i­al;

c.

an­onym­ously col­lec­ted or an­onymised health-re­lated data.

In this Act:

a.

Re­search means meth­od-driv­en search for gen­er­al­is­able know­ledge;

b.

Re­search con­cern­ing dis­eases means re­search on the causes, pre­ven­tion, dia­gnos­is, treat­ment and epi­demi­ology of impair­ments of phys­ic­al and men­tal health in hu­man be­ings;

c.

Re­search con­cern­ing the struc­ture and func­tion of the hu­man body means ba­sic re­search, in par­tic­u­lar on hu­man ana­tomy, physiology and ge­net­ics, and non-dis­ease-re­lated re­search con­cern­ing in­ter­ven­tions and im­pacts on the hu­man body;

d.

Re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit means a re­search pro­ject whose res­ults can be ex­pec­ted to im­prove the health of the par­ti­cipants;

e.

Bio­lo­gic­al ma­ter­i­al means bod­ily sub­stances de­rived from liv­ing per­sons;

f.

Health-re­lated per­son­al data means in­form­a­tion con­cern­ing the health or dis­ease of a spe­cif­ic or iden­ti­fi­able per­son, in­clud­ing ge­net­ic data;

g.

Ge­net­ic data means in­form­a­tion on a per­son's genes, ob­tained by ge­net­ic test­ing;

h.

Coded bio­lo­gic­al ma­ter­i­al and coded health-re­lated per­son­al data meansbio­lo­gic­al ma­ter­i­al and data linked to a spe­cif­ic per­son via a code;

i.

An­onymised bio­lo­gic­al ma­ter­i­al and an­onymised health-re­lated data meansbio­lo­gic­al ma­ter­i­al and health-re­lated data which can­not (without dis­pro­por­tion­ate ef­fort) be traced to a spe­cif­ic per­son;

j.

Child means a leg­al minor un­der 14 years of age;

k.

Ad­oles­cent means a leg­al minor aged 14 years or more;

l.⁴

...

The in­terests, health and wel­fare of the in­di­vidu­al hu­man be­ing shall pre­vail over the in­terests of sci­ence and so­ci­ety.

Re­search in­volving hu­man be­ings may only be car­ried out if it ad­dresses a top­ic of sci­entif­ic rel­ev­ance con­cern­ing:

the un­der­stand­ing of hu­man dis­eases;

the struc­ture and func­tion of the hu­man body; or

pub­lic health.

¹ Nobody is to be sub­jec­ted to dis­crim­in­a­tion in con­nec­tion with re­search.

² With re­gard to the se­lec­tion of par­ti­cipants in par­tic­u­lar, no group of per­sons shall be dis­pro­por­tion­ately in­cluded in or ex­cluded from re­search without good reas­on.

¹ Re­search in­volving hu­man be­ings may only be car­ried out if, in ac­cord­ance with the pro­vi­sions of this Act, the per­sons con­cerned have giv­en their in­formed con­sent or, after be­ing duly in­formed, have not ex­er­cised their right to dis­sent.

² The per­sons con­cerned may with­hold or re­voke their con­sent at any time, without stat­ing their reas­ons.

¹ The per­sons con­cerned are en­titled to be in­formed of res­ults re­lat­ing to their health. The in­form­a­tion is to be com­mu­nic­ated in an ap­pro­pri­ate man­ner. The per­sons con­cerned may choose to forgo such in­form­a­tion.

² They are en­titled to be in­formed about all the per­son­al data held in re­la­tion to them.

¹ It is pro­hib­ited to of­fer, grant, de­mand or ac­cept pay­ment or any oth­er non-cash ad­vant­age in ex­change for the hu­man body or parts there­of as such.

² It is also pro­hib­ited to use the hu­man body or parts there­of if they have been sub­ject to a pro­hib­ited act as spe­cified in para­graph 1.

¹ Re­search in­volving hu­man be­ings may only be car­ried out if:

a.

the re­cog­nised reg­u­la­tions con­cern­ing sci­entif­ic in­teg­rity are com­plied with, in par­tic­u­lar with re­gard to the hand­ling of con­flicts of in­terest;

b.

sci­entif­ic qual­ity re­quire­ments are met;

c.

the re­cog­nised in­ter­na­tion­al Good Prac­tice guidelines for re­search in­volving hu­man be­ings are com­plied with; and

d.

the per­sons re­spons­ible have ap­pro­pri­ate pro­fes­sion­al qual­i­fic­a­tions.

² The Fed­er­al Coun­cil shall spe­cify which na­tion­al and in­ter­na­tion­al reg­u­la­tions must be com­plied with.

¹ A re­search pro­ject in­volving per­sons may only be car­ried out if equi­val­ent find­ings can­not be ob­tained by oth­er means.

² A re­search pro­ject in­volving par­tic­u­larly vul­ner­able per­sons may only be car­ried out if equi­val­ent find­ings can­not be ob­tained by oth­er means.

¹ In every re­search pro­ject, the risks and bur­dens for the par­ti­cipants must be min­im­ised as far as pos­sible.

² The likely risks and bur­dens for the par­ti­cipants must not be dis­pro­por­tion­ate to the ex­pec­ted be­ne­fits of the re­search pro­ject.

In re­search pro­jects with an ex­pec­ted dir­ect be­ne­fit, the use of a placebo or non‑treat­ment is only per­miss­ible if no ad­di­tion­al risk of ser­i­ous or ir­re­vers­ible harm is to be ex­pec­ted for the per­sons con­cerned and:

no stand­ard treat­ment is avail­able; or

the use of a placebo is re­quired for com­pel­ling, sci­en­tific­ally sound meth­od­o­lo­gic­al reas­ons, in or­der to es­tab­lish the ef­fic­acy or safety of a treat­ment meth­od.

¹ No per­son may re­ceive pay­ment or any oth­er non-cash ad­vant­age for par­ti­cip­a­tion in a re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit. Par­ti­cip­a­tion in a re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may be ap­pro­pri­ately re­mu­ner­ated.

² No per­son may de­mand or ac­cept pay­ment or any oth­er non-cash ad­vant­age from an­oth­er in re­turn for the lat­ter’s par­ti­cip­a­tion in a re­search pro­ject.

¹ Any­one who con­ducts a re­search pro­ject must, be­fore it be­gins, take all the meas­ures re­quired to pro­tect the par­ti­cipants.

² If, dur­ing the re­search pro­ject, cir­cum­stances arise which could jeop­ard­ise the safety or health of the par­ti­cipants or lead to a dis­pro­por­tion­ate re­la­tion­ship between the risks and bur­dens and the be­ne­fits, all the meas­ures re­quired to en­sure pro­tec­tion are to be taken without delay.

¹ Per­sons may only be in­volved in a re­search pro­ject if they have giv­en their in­formed con­sent. Con­sent must be giv­en in writ­ing; the Fed­er­al Coun­cil may spe­cify ex­emp­tions.

² The per­sons con­cerned must re­ceive com­pre­hens­ible or­al and writ­ten in­form­a­tion on:

a.

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

b.

the fore­see­able risks and bur­dens;

c.

the ex­pec­ted be­ne­fits of the re­search pro­ject, in par­tic­u­lar for them­selves or for oth­er people;

d.

the meas­ures taken to pro­tect the per­son­al data col­lec­ted;

e.

their rights.

³ Be­fore a de­cision on con­sent is made by the per­sons con­cerned, they must be al­lowed an ap­pro­pri­ate peri­od for re­flec­tion.

⁴ The Fed­er­al Coun­cil may spe­cify fur­ther ele­ments of the in­form­a­tion to be provided.

If the in­ten­tion ex­ists to make fur­ther use for re­search of bio­lo­gic­al ma­ter­i­al sampled or health-re­lated per­son­al data col­lec­ted, the con­sent of the per­sons con­cerned must be ob­tained at the time of such sampling or col­lec­tion, or they must be in­formed of their right to dis­sent.

¹ In ex­cep­tion­al cases, the per­sons con­cerned may be giv­en in­com­plete in­form­a­tion re­gard­ing in­di­vidu­al as­pects of a re­search pro­ject be­fore it be­gins:

a.

in­so­far as this is es­sen­tial for meth­od­o­lo­gic­al reas­ons; and

b.

if the re­search pro­ject en­tails no more than min­im­al risks and bur­dens.

² The par­ti­cipants must sub­sequently be duly in­formed as soon as pos­sible.

³ Once they have been in­formed in ac­cord­ance with para­graph 2, they may give or with­hold their con­sent to the use of their bio­lo­gic­al ma­ter­i­al or their data. Only when such con­sent has been giv­en is the bio­lo­gic­al ma­ter­i­al or data to be used for the re­search pro­ject.

¹ Any per­son who car­ries out a re­search pro­ject in­volving per­sons shall be li­able for dam­age suffered by them in con­nec­tion with the pro­ject. The Fed­er­al Coun­cil may spe­cify ex­emp­tions from li­ab­il­ity.

2 Com­pens­a­tion claims pre­scribe in ac­cord­ance with Art­icle 60 of the Swiss Code of Ob­lig­a­tions.⁶ The Fed­er­al Coun­cil may spe­cify a longer pre­script­ive peri­od for par­tic­u­lar re­search areas.⁷

³ The pro­vi­sions of the Code of Ob­lig­a­tions on tort are oth­er­wise ap­plic­able; in the ex­er­cise of of­fi­cial du­ties, the Gov­ern­ment Li­ab­il­ity Act of 14 March 1958⁸, or can­ton­al gov­ern­ment li­ab­il­ity law, is ap­plic­able.

¹ Li­ab­il­ity must be ap­pro­pri­ately covered through in­sur­ance or in some oth­er man­ner. The Fed­er­al Gov­ern­ment and its pub­lic-law in­sti­tu­tions and cor­por­a­tions are ex­empt from the li­ab­il­ity cov­er­age re­quire­ments.

² The Fed­er­al Coun­cil may:

a.

spe­cify re­quire­ments for in­sur­ance and oth­er forms of cov­er­age;

b.

ex­empt re­search areas or classes of dam­age from the li­ab­il­ity cov­er­age re­quire­ments.

³ For the pro­tec­tion of the in­jured party, it may:

a.

grant this party a dir­ect claim against the party provid­ing li­ab­il­ity cov­er­age;

b.

re­strict the can­cel­la­tion rights and ob­jec­tions of the party provid­ing li­ab­il­ity cov­er­age, while grant­ing ap­pro­pri­ate rights of re­course.

1 Chil­dren, ad­oles­cents and adults lack­ing ca­pa­city must be in­volved as far as pos­sible in the con­sent pro­ced­ure.

2 In­creas­ing weight must be ac­cor­ded to the views of chil­dren and ad­oles­cents lack­ing ca­pa­city the older and more ma­ture they are.

¹ A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit may only be car­ried out in chil­dren who are cap­able of judge­ment if:

a.

the child has giv­en in­formed con­sent; and

b.

the leg­al rep­res­ent­at­ive has giv­en in­formed con­sent in writ­ing.

² A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may only be car­ried out in chil­dren who are cap­able of judge­ment if, in ad­di­tion to para­graph 1:

a.

it en­tails no more than min­im­al risks and bur­dens; and

b.

it can be ex­pec­ted to yield sub­stan­tial find­ings which could in the long term be be­ne­fi­cial for per­sons with the same dis­ease or dis­order, or in the same situ­ation.

³ A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit may only be car­ried out in chil­dren who lack ca­pa­city if:

a.

the leg­al rep­res­ent­at­ive has giv­en in­formed con­sent in writ­ing; and

b.

the child does not vis­ibly ex­press op­pos­i­tion to the re­search in­ter­ven­tion either verbally or by his or her be­ha­viour.

⁴ A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may only be car­ried out in chil­dren who lack ca­pa­city if the re­quire­ments spe­cified in para­graphs 2 and 3 are met.

¹ A re­search pro­ject with or without an ex­pec­ted dir­ect be­ne­fit may only be car­ried out in ad­oles­cents who are cap­able of judge­ment if:

a.

the ad­oles­cent has giv­en in­formed con­sent in writ­ing; and

b.

the leg­al rep­res­ent­at­ive has giv­en in­formed con­sent in writ­ing if the re­search pro­ject en­tails more than min­im­al risks and bur­dens.

² A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit may only be car­ried out in ad­oles­cents who lack ca­pa­city if:

a.

the leg­al rep­res­ent­at­ive has giv­en in­formed con­sent in writ­ing; and

b.

the ad­oles­cent does not vis­ibly ex­press op­pos­i­tion to the re­search in­ter­ven­tion either verbally or by his or her be­ha­viour.

³ A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may only be car­ried out in ad­oles­cents who lack ca­pa­city if, in ad­di­tion to the re­quire­ments spe­cified in para­graph 2:

a.

it en­tails no more than min­im­al risks and bur­dens; and

b.

it can be ex­pec­ted to yield sub­stan­tial find­ings which could in the long term be be­ne­fi­cial for per­sons with the same dis­ease or dis­order, or in the same situ­ation.

¹ A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit may only be car­ried out in adults who lack ca­pa­city if:

a.

this is per­mit­ted by the con­sent of the per­son con­cerned, gran­ted while in a state of ca­pa­city and duly doc­u­mented;

b.

in­formed con­sent has been giv­en in writ­ing by the leg­al rep­res­ent­at­ive, a des­ig­nated trus­ted per­son or the next of kin, if no doc­u­mented con­sent is avail­able; and

c.

the per­son con­cerned does not vis­ibly ex­press op­pos­i­tion to the re­search in­ter­ven­tion either verbally or by his or her be­ha­viour.

² A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may only to be car­ried out in adults who lack ca­pa­city if, in ad­di­tion to the re­quire­ments spe­cified in para­graph 1:

a.

it en­tails no more than min­im­al risks and bur­dens; and

b.

it can be ex­pec­ted to yield sub­stan­tial find­ings which could in the long term be be­ne­fi­cial for per­sons with the same dis­ease or dis­order, or in the same situ­ation.

Re­search pro­jects de­signed to modi­fy prop­er­ties of an em­bryo or foetus for non‑dis­ease-re­lated reas­ons are pro­hib­ited.

¹ A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit for a preg­nant wo­man or for an em­bryo or foetus may only be car­ried out if the fore­see­able risks and bur­dens, both for the preg­nant wo­man and for the em­bryo or foetus, are not dis­pro­por­tion­ate to the ex­pec­ted be­ne­fits.

² A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit for the preg­nant wo­man or for the em­bryo or foetus may only be car­ried out if:

a.

it en­tails no more than min­im­al risks and bur­dens for the em­bryo or foetus; and

b.

it can be ex­pec­ted to yield sub­stan­tial find­ings which could in the long term be be­ne­fi­cial for preg­nant wo­men or for em­bry­os or foetuses.

¹ A preg­nant wo­man may only be asked wheth­er she wishes to par­ti­cip­ate in a re­search pro­ject con­cern­ing meth­ods of in­duced abor­tion after she has de­cided to un­der­go an abor­tion.

² Art­icle 26 does not ap­ply.

¹ For re­search pro­jects with an ex­pec­ted dir­ect be­ne­fit which in­volve pris­on­ers, the gen­er­al re­quire­ments for re­search in­volving per­sons ap­ply; however, Art­icle 11 para­graph 2 does not ap­ply.

² A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit which in­volves pris­on­ers may only be car­ried out if it en­tails no more than min­im­al risks and bur­dens.

Par­ti­cip­a­tion in a re­search pro­ject must not be as­so­ci­ated with re­lax­ing the con­di­tions of im­pris­on­ment.

¹ A re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit may be car­ried out in emer­gency situ­ations if:

a.

the ne­ces­sary meas­ures have been taken so that the wishes of the per­son con­cerned can be de­term­ined as soon as pos­sible;

b.

the per­son con­cerned does not vis­ibly ex­press op­pos­i­tion to the re­search in­ter­ven­tion through either verbally or by his or her be­ha­viour; and

c.

a phys­i­cian who is not par­ti­cip­at­ing in the re­search pro­ject is called in to safe­guard the in­terests of the per­son con­cerned be­fore he or she is in­volved in the pro­ject; in ex­cep­tion­al cases, where there are good reas­ons for do­ing so, the phys­i­cian may be called in at a later stage.

² A re­search pro­ject with no ex­pec­ted dir­ect be­ne­fit may be car­ried out in emer­gency situ­ations if, in ad­di­tion to the re­quire­ments spe­cified in para­graph 1:

a.

it en­tails no more than min­im­al risks and bur­dens; and

b.

it can be ex­pec­ted to yield sub­stan­tial find­ings which could in the long term be be­ne­fi­cial for per­sons with the same dis­ease or dis­order, or in the same situ­ation.

¹ The per­son con­cerned must be duly in­formed about the re­search pro­ject as soon as this be­comes pos­sible. He or she may sub­sequently give or with­hold con­sent.

² If the per­son con­cerned re­fuses to give post hoc con­sent, the bio­lo­gic­al ma­ter­i­al and data may no longer be used for the re­search pro­ject.

³ The Fed­er­al Coun­cil shall spe­cify the pro­ced­ure for the pro­cure­ment of post hoc or proxy con­sent, in par­tic­u­lar with re­gard to the in­volve­ment of chil­dren, ad­oles­cents and adults lack­ing ca­pa­city.

¹ Fur­ther use may be made of bio­lo­gic­al ma­ter­i­al and ge­net­ic data in un­coded form for a re­search pro­ject if in­formed con­sent has been giv­en by the per­son con­cerned, or by the leg­al rep­res­ent­at­ive or next of kin. For con­sent, Art­icles 16 and 22–24 ap­ply mu­tatis mutandis.

² Fur­ther use may be made of bio­lo­gic­al ma­ter­i­al and ge­net­ic data in coded form for re­search pur­poses if in­formed con­sent has been giv­en by the per­son con­cerned, or by the leg­al rep­res­ent­at­ive or next of kin. For con­sent, Art­icles 16 and 22–24 ap­ply mu­tatis mutandis.

³ Bio­lo­gic­al ma­ter­i­al and ge­net­ic data may be an­onymised for re­search pur­poses if the per­son con­cerned or the leg­al rep­res­ent­at­ive or next of kin have been in­formed in ad­vance and have not dis­sen­ted to an­onymisa­tion. For dis­sent, Art­icles 22–24 ap­ply mu­tatis mutandis.

¹ Fur­ther use may be made of non-ge­net­ic health-re­lated per­son­al data in un­coded form for re­search pur­poses if in­formed con­sent has been giv­en by the per­son con­cerned, or by the leg­al rep­res­ent­at­ive or next of kin. For con­sent, Art­icles 16 and 22–24 ap­ply mu­tatis mutandis.

² Fur­ther use may be made of non-ge­net­ic health-re­lated per­son­al data in coded form for re­search pur­poses if the per­son con­cerned or the leg­al rep­res­ent­at­ive or next of kin have been in­formed in ad­vance and have not dis­sen­ted. For dis­sent, Art­icles 22–24 ap­ply mu­tatis mutandis.

If the re­quire­ments for in­formed con­sent spe­cified in Art­icles 32 and 33 are not met, fur­ther use may be made of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data for re­search pur­poses in ex­cep­tion­al cases if:

a.

it is im­possible or dis­pro­por­tion­ately dif­fi­cult to ob­tain con­sent or to provide in­form­a­tion on the right to dis­sent, or this would im­pose an un­due bur­den on the per­son con­cerned;

b.

no doc­u­mented re­fus­al is avail­able; and

c.

the in­terests of re­search out­weigh the in­terests of the per­son con­cerned in de­cid­ing on the fur­ther use of his or her bio­lo­gic­al ma­ter­i­al and data.

The Fed­er­al Coun­cil shall spe­cify the re­quire­ments for cor­rect and se­cure an­onymisa­tion and cod­ing and also the con­di­tions for break­ing the code.

¹ Re­search may be car­ried out in de­ceased per­sons if, be­fore their death, the per­sons con­cerned con­sen­ted to the use of their body for re­search pur­poses.

² If no doc­u­mented con­sent or re­fus­al of the de­ceased per­son is avail­able, the body or parts there­of may be used for re­search pur­poses if con­sent is giv­en by the next of kin or by a trus­ted per­son des­ig­nated dur­ing the life­time of the de­ceased per­son.

³ The con­sent of the next of kin or the trus­ted per­son is gov­erned by Art­icle 8 of the Trans­plant­a­tion Act of 8 Oc­to­ber 2004⁹.

⁴ In the case of de­ceased per­sons whose death oc­curred more than 70 years pre­vi­ously, re­search may be car­ried out without con­sent be­ing giv­en as spe­cified in para­graph 2. If such re­search is op­posed by the next of kin, it may not be car­ried out.

¹ A re­search pro­ject may be car­ried out in de­ceased per­sons when their death has been de­term­ined.

² A re­search pro­ject may be car­ried out in de­ceased per­sons un­der­go­ing ar­ti­fi­cial res­pir­a­tion if, in ad­di­tion to the re­quire­ment spe­cified in para­graph 1, equi­val­ent find­ings can­not be ob­tained with de­ceased per­sons not un­der­go­ing ar­ti­fi­cial res­pir­a­tion. The Fed­er­al Coun­cil may spe­cify fur­ther con­di­tions.

³ Any­one who car­ries out a re­search pro­ject in ac­cord­ance with para­graph 2 must not have been in­volved in the de­term­in­a­tion of death or be au­thor­ised to is­sue in­struc­tions to the per­sons in­volved in this pro­ced­ure.

Small quant­it­ies of bod­ily sub­stances re­moved in the course of an autopsy or trans­plant­a­tion may be an­onymised for re­search pur­poses without con­sent, in the ab­sence of a doc­u­mented re­fus­al of the de­ceased per­son.

¹ A preg­nant wo­man may only be asked wheth­er she wishes to make her em­bryo or foetus avail­able for re­search pur­poses after she has de­cided to un­der­go an abor­tion. For con­sent, Art­icles 16 and 22–24 ap­ply mu­tatis mutandis.

² The time and meth­od of in­duced abor­tion must be chosen without re­gard to the re­search pro­ject.

³ Em­bry­os and foetuses from in­duced abor­tions may be used for a re­search pro­ject when death has been de­term­ined.

⁴ Any­one who car­ries out a re­search pro­ject in ac­cord­ance with para­graph 3 must not be in­volved in the abor­tion or be au­thor­ised to is­sue in­struc­tions to the per­sons in­volved in this pro­ced­ure.

¹ Em­bry­os and foetuses from spon­tan­eous abor­tions in­clud­ing still­births may only be used for re­search pur­poses with the con­sent of the couple con­cerned. For con­sent, Art­icle 16 ap­plies mu­tatis mutandis.

² Em­bry­os and foetuses from spon­tan­eous abor­tions may be used for a re­search pro­ject when death has been de­term­ined.

Bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data which has been sampled or col­lec­ted or of which fur­ther use has been made for re­search pur­poses may only be passed on for pur­poses oth­er than re­search if:

a.

a leg­al basis ex­ists for such a trans­fer; or

b.

in the par­tic­u­lar case, in­formed con­sent to the trans­fer has been giv­en by the per­son con­cerned.

¹ Bio­lo­gic­al ma­ter­i­al or ge­net­ic data may be ex­por­ted for re­search pur­poses if in­formed con­sent has been giv­en by the per­son con­cerned. For con­sent, Art­icles 16 and 22–24 and 32 ap­ply mu­tatis mutandis.

² Non-ge­net­ic health-re­lated per­son­al data may be dis­closed abroad for re­search pur­poses if the re­quire­ments spe­cified in Art­icle 6 of the Fed­er­al Act of 19 June 1992¹⁰ on Data Pro­tec­tion are met.

¹ Any­one who stores bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data for re­search pur­poses must take ap­pro­pri­ate tech­nic­al and or­gan­isa­tion­al meas­ures to pre­vent un­au­thor­ised use there­of, and ful­fil the op­er­a­tion­al and pro­fes­sion­al re­quire­ments.

² The Fed­er­al Coun­cil shall spe­cify the re­quire­ments for stor­age.

Art­icles 41–43 ap­ply mu­tatis mutandis to de­ceased per­sons, to em­bry­os and foetuses in­clud­ing still­births and parts there­of, and to data col­lec­ted in this con­nec­tion.

¹ Au­thor­isa­tion from the re­spons­ible eth­ics com­mit­tee is re­quired for:

a.

con­duct­ing a re­search pro­ject; or

b.

mak­ing fur­ther use of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data for re­search pur­poses in cases where con­sent has not been ob­tained or in­form­a­tion on the right to dis­sent has not been provided (Art. 34).

² Au­thor­isa­tion is gran­ted if the eth­ic­al, leg­al and sci­entif­ic re­quire­ments of this Act are met. The de­cision must be avail­able with­in two months of sub­mis­sion of the ap­plic­a­tion. The Fed­er­al Coun­cil may:

a.

spe­cify short­er, risk-ad­ap­ted max­im­um lim­its for pro­cessing peri­ods;

b.

ad­just the pro­cessing peri­ods, if this is re­quired by re­cog­nised in­ter­na­tion­al reg­u­la­tions.¹¹

³ The Fed­er­al Coun­cil may make changes to re­search pro­jects sub­ject to au­thor­isa­tion. In do­ing so, it shall have re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions.

¹ The Fed­er­al Coun­cil may spe­cify no­ti­fic­a­tion or in­form­a­tion re­quire­ments, in par­tic­u­lar with re­gard to:

a.

the com­ple­tion or dis­con­tinu­ation of a re­search pro­ject;

b.

ad­verse events ob­served in con­nec­tion with a re­search pro­ject;

c.

the oc­cur­rence of cir­cum­stances dur­ing the con­duct of a re­search pro­ject which could af­fect the safety or health of the par­ti­cipants.

² In do­ing so, it shall have re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions.

¹ The re­spons­ible eth­ics com­mit­tee is that of the can­ton in whose ter­rit­ory the re­search is con­duc­ted.

² If a re­search pro­ject is car­ried out ac­cord­ing to a stand­ard pro­tocol, but in dif­fer­ent can­tons (mul­ti­centre re­search pro­ject), au­thor­isa­tion is re­quired from the eth­ics com­mit­tee which is re­spons­ible at the site of activ­ity of the pro­ject co­ordin­at­or (the lead com­mit­tee).

³ In or­der to as­sess wheth­er the pro­fes­sion­al and op­er­a­tion­al re­quire­ments are ful­filled in oth­er can­tons, the lead com­mit­tee shall seek the opin­ion of the eth­ics com­mit­tees con­cerned. It shall be bound by their opin­ion.

⁴ Para­graphs 2 and 3 ap­ply mu­tatis mutandis to au­thor­isa­tion for the use in ac­cord­ance with Art­icle 34 of bio­lo­gic­al ma­ter­i­al and health-re­lated per­son­al data of which fur­ther use is made or which are col­lec­ted ac­cord­ing to a stand­ard pro­tocol, but in dif­fer­ent can­tons.

¹ If the safety or health of the per­sons con­cerned is at risk, the eth­ics com­mit­tee may re­voke or sus­pend its au­thor­isa­tion or make the con­tinu­ation of the re­search pro­ject sub­ject to ad­di­tion­al con­di­tions.

² The eth­ics com­mit­tee may re­quest in­form­a­tion or doc­u­ment­a­tion from the hold­er of the au­thor­isa­tion. This must be provided or made avail­able free of charge.

³ The com­pet­ent fed­er­al and can­ton­al au­thor­it­ies re­tain the right to take meas­ures.

⁴ The au­thor­it­ies and eth­ics com­mit­tees shall keep each oth­er in­formed and co­ordin­ate their meas­ures.

¹ The doc­u­ments for the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures, and for re­port­ing and su­per­vi­sion, shall be sub­mit­ted to the can­ton­al in­form­a­tion sys­tem re­ferred to in Art­icle 56a.¹²

^1bis The Fed­er­al Coun­cil shall spe­cify re­quire­ments for the pro­ced­ure so as to en­sure con­sist­ent en­force­ment and the im­ple­ment­a­tion of na­tion­al and in­ter­na­tion­al reg­u­la­tions. It may stip­u­late that the sub­mis­sion of ap­plic­a­tions, cor­res­pond­ence and the pub­lic­a­tion of de­cisions must be ef­fected elec­tron­ic­ally.¹³

² In par­tic­u­lar for re­search pro­jects in­volving bio­lo­gic­al ma­ter­i­al and ge­net­ic data in ac­cord­ance with Art­icle 32, or non-ge­net­ic health-re­lated per­son­al data in ac­cord­ance with Art­icle 33, it may spe­cify less strin­gent pro­ced­ur­al re­quire­ments.

³ Can­ton­al pro­ced­ur­al law oth­er­wise ap­plies.

1 The pro­ced­ure for ap­peals against eth­ics com­mit­tee de­cisions is gov­erned by can­ton­al pro­ced­ur­al law and the gen­er­al pro­vi­sions con­cern­ing the ad­min­is­tra­tion of fed­er­al justice.

² The ap­peal­ing party may not file an ap­peal based on sub­stant­ive in­ap­pro­pri­ate­ness.

¹ With­in the frame­work of their re­spons­ib­il­it­ies un­der Chapter 8, eth­ics com­mit­tees shall as­sess wheth­er re­search pro­jects and the con­duct there­of com­ply with the eth­ic­al, leg­al and sci­entif­ic re­quire­ments of this Act. In par­tic­u­lar, they shall as­sess wheth­er the pro­tec­tion of the per­sons con­cerned is guar­an­teed.

² They may ad­vise re­search­ers in par­tic­u­lar on eth­ic­al ques­tions and, if so re­ques­ted by the re­search­ers, com­ment on re­search pro­jects not sub­ject to this Act, and spe­cific­ally pro­jects car­ried out abroad.

¹ Eth­ics com­mit­tees shall ex­er­cise their du­ties in a pro­fes­sion­ally in­de­pend­ent man­ner, without be­ing sub­ject to in­struc­tions from the su­per­vis­ory au­thor­ity in this re­gard.

² The mem­bers of eth­ics com­mit­tees shall dis­close their in­terests. Each eth­ics com­mit­tee shall main­tain a pub­licly ac­cess­ible re­gister of in­terests.

³ Mem­bers who are in­ter­ested parties shall not par­ti­cip­ate in the as­sess­ment and de­cision pro­ced­ures.

¹ Eth­ics com­mit­tees must be com­posed in such a way that they have the pro­fes­sion­al skills and ex­per­i­ence re­quired to dis­charge their du­ties. The mem­bers must in­clude:

a.

ex­perts in vari­ous dis­cip­lines, in par­tic­u­lar medi­cine, eth­ics and law; and

b.

at least one per­son rep­res­ent­ing pa­tients.¹⁴

² Eth­ics com­mit­tees may call in ex­tern­al spe­cial­ists to serve as ex­perts.

³ The Fed­er­al Coun­cil shall en­act ad­di­tion­al reg­u­la­tions con­cern­ing the com­pos­i­tion of eth­ics com­mit­tees and the re­quire­ments to be ful­filled by their mem­bers. In do­ing so, it shall have re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions.

¹ Each can­ton shall des­ig­nate the eth­ics com­mit­tee re­spons­ible for its ter­rit­ory and ap­point the mem­bers there­of. It shall over­see the activ­it­ies of the eth­ics com­mit­tee.

² Each can­ton has at most one eth­ics com­mit­tee. Sev­er­al can­tons may ap­point a joint eth­ics com­mit­tee or agree that one can­ton's eth­ics com­mit­tee is also to be re­spons­ible for oth­er can­tons.

³ The Fed­er­al Coun­cil may is­sue guidelines con­cern­ing the min­im­um num­ber of re­search pro­jects to be as­sessed by an eth­ics com­mit­tee per year. It shall first con­sult the can­tons.

⁴ Each eth­ics com­mit­tee shall have a sci­entif­ic sec­ret­ari­at. De­tails of the or­gan­isa­tion and work­ing meth­ods are to be pub­licly ac­cess­ible in by-laws.

⁵ The can­ton shall as­sure the fin­an­cing of the eth­ics com­mit­tee. It may make pro­vi­sion for the char­ging of fees.

¹ The Fed­er­al Of­fice of Pub­lic Health (FOPH) is re­spons­ible for co­ordin­a­tion between eth­ics com­mit­tees and with oth­er su­per­vis­ory au­thor­it­ies. It may del­eg­ate this re­spons­ib­il­ity to third parties.

² Eth­ics com­mit­tees shall re­port an­nu­ally to the FOPH on their activ­it­ies, in par­tic­u­lar on the type and num­ber of re­search pro­jects as­sessed and on the pro­cessing peri­ods.

³ The FOPH shall pub­lish a list of eth­ics com­mit­tees and in­form the pub­lic reg­u­larly about their activ­it­ies.

⁴ In con­sulta­tion with the eth­ics com­mit­tees and oth­er su­per­vis­ory au­thor­it­ies con­cerned, it may is­sue re­com­mend­a­tions for ap­pro­pri­ate har­mon­isa­tion of pro­ced­ures and of as­sess­ment prac­tice.

¹ Au­thor­ised clin­ic­al tri­als must be re­cor­ded in a pub­lic re­gistry. The Fed­er­al Coun­cil shall define the clin­ic­al tri­als in more de­tail and may spe­cify ex­emp­tions from man­dat­ory re­gis­tra­tion; in do­ing so, it shall be guided by re­cog­nised in­ter­na­tion­al reg­u­la­tions.¹⁵

² It shall des­ig­nate the re­gistry, provide in­form­a­tion on ac­cess thereto and spe­cify the con­tent of re­gis­tra­tion, as well as no­ti­fic­a­tion re­quire­ments and the no­ti­fic­a­tion pro­ced­ure. In do­ing so, it shall have re­gard to re­cog­nised in­ter­na­tion­al reg­u­la­tions and if pos­sible take ex­ist­ing re­gis­tries in­to con­sid­er­a­tion.

³ It may:

a.

en­trust pub­lic- or private-law or­gan­isa­tions with the es­tab­lish­ment and man­age­ment of the re­gistry;

b.¹⁶

spe­cify that the res­ults of re­gistered re­search pro­jects must be pub­lished on a re­cog­nised plat­form.

¹ The can­tons shall op­er­ate a shared in­form­a­tion sys­tem for the con­duct of au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures, the trans­mis­sion of re­ports and the su­per­vi­sion of re­search pro­jects.

² The sys­tem shall con­tain data, in­clud­ing per­son­al data on ad­min­is­trat­ive or crim­in­al pro­ceed­ings and sanc­tions or on health, which is ne­ces­sary for the con­duct of au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures and for re­port­ing and su­per­vi­sion in ac­cord­ance with this Act.

³ The can­tons shall en­sure that the in­form­a­tion sys­tem is com­pat­ible with the Med­ic­al Devices In­form­a­tion Sys­tem of the Swiss Agency for Thera­peut­ic Products and with the European data­base on med­ic­al devices (Eu­damed).

⁴ The Fed­er­al Coun­cil may spe­cify that:

a.

the data re­ferred to in para­graph 2 con­cern­ing clin­ic­al tri­als with med­ic­al devices is to be auto­mat­ic­ally aligned with the Med­ic­al Devices In­form­a­tion Sys­tem of the Swiss Agency for Thera­peut­ic Products or with Eu­damed;

b.

any data re­ferred to in para­graph 2 which is not sens­it­ive is to be pub­lished with due pro­tec­tion of pro­fes­sion­al con­fid­en­ti­al­ity and trade secrets.

Per­sons re­spons­ible for the en­force­ment of this Act have a duty to main­tain con­fid­en­ti­al­ity.

In dis­char­ging their du­ties, eth­ics com­mit­tees and the oth­er en­force­ment bod­ies are en­titled to pro­cess per­son­al data. Sens­it­ive per­son­al data may be pro­cessed, in­so­far as this is ne­ces­sary.

¹ Where no con­flict­ing private in­terest of over­rid­ing im­port­ance ex­ists, data may be dis­closed to:

a.

the fed­er­al and can­ton­al agen­cies re­spons­ible for en­force­ment of this Act, and to pub­lic- or private-law or­gan­isa­tions and per­sons if they re­quire the data to ful­fil the du­ties as­signed to them un­der this Act;

b.

crim­in­al in­vest­ig­a­tion au­thor­it­ies if the data is re­quired to pro­sec­ute or pre­vent a felony or an of­fence un­der this Act.

² Where no con­flict­ing private in­terest of over­rid­ing im­port­ance ex­ists, data may, in in­di­vidu­al cases, fol­low­ing a writ­ten re­quest, be dis­closed to:

a.

civil courts if the data is re­quired to judge a court case;

b.

crim­in­al courts and crim­in­al in­vest­ig­a­tion au­thor­it­ies if the data is re­quired to in­vest­ig­ate a felony or mis­de­mean­our.

³ Data which is of gen­er­al in­terest and relates to the ap­plic­a­tion of this Act may be pub­lished. The data sub­jects must not be iden­ti­fi­able.

⁴ In oth­er cases, data may be dis­closed to third parties as fol­lows:

a.

data not re­lat­ing to spe­cif­ic per­sons, provided that there is an over­rid­ing in­terest in this data be­ing made avail­able;

b.

per­son­al data, provided that the data sub­ject has giv­en writ­ten con­sent in each case.

⁵ Only the data which is re­quired for the pur­pose in ques­tion may be dis­closed.

⁶ The Fed­er­al Coun­cil shall reg­u­late the de­tails of the dis­clos­ure of data and the no­ti­fic­a­tion of the per­sons con­cerned.

¹ Con­fid­en­tial data may only be trans­mit­ted to for­eign au­thor­it­ies and in­sti­tu­tions or to in­ter­na­tion­al or­gan­isa­tions if:

a.

this is re­quired by agree­ments un­der in­ter­na­tion­al law or res­ol­u­tions passed by in­ter­na­tion­al or­gan­isa­tions;

b.

this is ne­ces­sary to avert an im­min­ent danger to life or health; or

c.

this would en­able ser­i­ous of­fences un­der this Act to be ex­posed.

² The Fed­er­al Coun­cil shall reg­u­late re­spons­ib­il­it­ies and the pro­ced­ures for ex­chan­ging data with for­eign au­thor­it­ies and in­sti­tu­tions and with in­ter­na­tion­al or­gan­isa­tions.

¹ The FOPH is re­spons­ible for as­sess­ing the ef­fect­ive­ness of this Act.

² The Fed­er­al De­part­ment of Home Af­fairs shall re­port to the Fed­er­al Coun­cil on the res­ults of the eval­u­ation and sub­mit pro­pos­als for fur­ther ac­tion.

¹ Un­less a more ser­i­ous of­fence has been com­mit­ted un­der the Crim­in­al Code¹⁸, any per­son who wil­fully:

a.

con­ducts a re­search pro­ject without the au­thor­isa­tion of an eth­ics com­mit­tee or de­vi­at­ing from an au­thor­ised pro­tocol (Art. 45) and thereby en­dangers the health of the par­ti­cipants;

b.

con­ducts a re­search pro­ject as defined in Chapter 2, 3, 5 or 6 without ob­tain­ing the con­sent re­quired un­der this Act (Arts. 16, 17, 18 para. 3, Art. 22 paras. 1, 3 let. a and 4, Arts. 23, 24, 26, 28, 30, 36 paras. 1 and 2, 39 para. 1, 40);

c.¹⁹

of­fers, grants, de­mands or ac­cepts pay­ment or any oth­er non-cash ad­vant­age in ex­change for the hu­man body or parts there­of as such;

c^bis.²⁰

uses the hu­man body or parts there­of if they have been sub­ject to a pro­hib­ited act as spe­cified in let­ter c;

d.

con­ducts a re­search pro­ject de­signed to modi­fy prop­er­ties of the em­bryo or foetus for non-dis­ease-re­lated reas­ons (Art. 25);

e.

uses em­bry­os or foetuses from in­duced or spon­tan­eous abor­tions for a re­search pro­ject be­fore death has been de­term­ined (Art. 39 para. 3, Art. 40 para. 2)

shall be li­able to a cus­todi­al sen­tence not ex­ceed­ing three years or to a mon­et­ary pen­alty.

² If the act is com­mit­ted for com­mer­cial gain, the pen­alty shall be a cus­todi­al sen­tence not ex­ceed­ing three years; this shall be com­bined with a mon­et­ary pen­alty.

³ If the act is com­mit­ted through neg­li­gence, the pen­alty shall be a mon­et­ary pen­alty not ex­ceed­ing 180 daily pen­alty units.

¹ Any per­son who wil­fully or neg­li­gently:

a.

com­mits an of­fence as spe­cified in Art­icle 62 para­graph 1 let­ter a without the par­ti­cipants' health be­ing en­dangered;

b.

makes a pay­ment or provides any oth­er non-cash ad­vant­age to a per­son for par­ti­cip­a­tion in a re­search pro­ject with an ex­pec­ted dir­ect be­ne­fit, or de­mands or ac­cepts pay­ment or any oth­er non-cash ad­vant­age from a per­son for par­ti­cip­a­tion in a re­search pro­ject (Art. 14);

c.

makes fur­ther use of bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data without the in­formed con­sent re­quired un­der this Act (Arts. 32, 33), in cases where the con­di­tions spe­cified in Art­icle 34 are not met and ap­pro­pri­ate au­thor­isa­tion has not been ob­tained from the re­spons­ible eth­ics com­mit­tee;

d.

trans­fers bio­lo­gic­al ma­ter­i­al or health-re­lated per­son­al data for non-re­search-re­lated pur­poses in the ab­sence of a leg­al basis or without the re­quis­ite con­sent (Art. 41)

shall be li­able to a fine.

² A con­tra­ven­tion and the pen­alty for a con­tra­ven­tion be­come time-barred after five years.

¹ The can­tons have jur­is­dic­tion for the pro­sec­u­tion and judg­ment of of­fences.

² Art­icles 6, 7 (of­fences com­mit­ted with­in a busi­ness) and 15 (for­gery of doc­u­ments, ob­tain­ing a false cer­ti­fic­ate by fraud) of the Fed­er­al Act of 22 March 1974²¹ on Ad­min­is­trat­ive Crim­in­al Law ap­ply.

³ The com­pet­ent au­thor­it­ies shall in­form the FOPH of all judg­ments passed in ac­cord­ance with Art­icle 62 para­graph 1 let­ters b–c^bis or Art­icle 63 para­graph 1 let­ter c on ac­count of an of­fence in­volving the hu­man body or parts there­of.²²

¹ The Fed­er­al Coun­cil shall en­act the im­ple­ment­ing pro­vi­sions.

² In do­ing so, it shall con­sider the dif­fer­ent ex­tents to which in­di­vidu­al re­search areas and meth­ods in­volve risks to dig­nity and pri­vacy, in par­tic­u­lar when spe­cify­ing:

the sci­entif­ic re­quire­ments (Art. 10);

b.

any ex­emp­tions from li­ab­il­ity (Art. 19) and li­ab­il­ity cov­er­age re­quire­ments (Art. 20);

c.

the re­quire­ments for in­sur­ance and oth­er forms of cov­er­age (Art. 20);

d.

the pro­ced­ur­al re­quire­ments (Art. 49).

Cur­rent le­gis­la­tion shall be amended as spe­cified in the An­nex.

¹ Au­thor­isa­tions gran­ted by can­ton­al eth­ics com­mit­tees for the con­duct of re­search pro­jects re­main val­id for the term of the au­thor­isa­tion.

² If no au­thor­isa­tion, as defined in para­graph 1, has been gran­ted for a re­search pro­ject which is already un­der way when this Act comes in­to ef­fect, an ap­plic­a­tion for au­thor­isa­tion in ac­cord­ance with Art­icle 45 para­graph 1 let­ter a shall be sub­mit­ted to the re­spons­ible eth­ics com­mit­tee with­in six months after the com­mence­ment of this Act.

³ Au­thor­isa­tions for the waiver of pro­fes­sion­al con­fid­en­ti­al­ity in med­ic­al re­search re­main val­id for the term of the au­thor­isa­tion. If the au­thor­isa­tion has been gran­ted for an un­lim­ited term, an ap­plic­a­tion for au­thor­isa­tion in ac­cord­ance with Art­icle 45 para­graph 1 shall be sub­mit­ted to the re­spons­ible eth­ics com­mit­tee with­in a year of the com­mence­ment of this Act.

⁴ The Fed­er­al Coun­cil shall reg­u­late the re­gis­tra­tion un­der Art­icle 56 of re­search pro­jects which are in pro­gress when this Act comes in­to force.

¹ This Act is sub­ject to an op­tion­al ref­er­en­dum.

² The Fed­er­al Coun­cil shall de­term­ine the com­mence­ment date.

Com­mence­ment Date: 1 Janu­ary 2014²³