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.
Art. 32 Further use of biological material and genetic data
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.
Art. 33 Further use of non-genetic health-related personal data
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.
Art. 34 Absence of informed consent
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.
Art. 35 Anonymisation and coding
The Federal Council shall specify the requirements for correct and secure anonymisation and coding and also the conditions for breaking the code.