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

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.