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

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.