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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 30 September 2011 (Status as of 26 May 2021)


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Art. 22 Research projects involving children

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.

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