Human Research Act (HRA)

By Steph2
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In The Matter OfHuman Research Act (HRA)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Art. 62 Misdemeanours

1 Unless a more serious offence has been committed under the Criminal Code, 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. offers, grants, demands or accepts payment or any other non-cash advantage in exchange for the human body or parts thereof as such; cbis. 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 befo

Para. 1 — SR 311.0 Para. 1 let. c — Amended by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971). Para. 1 let. cbis — Inserted by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971). P

Art. 63 Contraventions

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 t

Art. 64 Jurisdiction and administrative criminal law

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 1974 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–cbis or Article 63 paragraph 1 letter c on account of an offence involving the human body or parts thereof.

Para. 2 — SR 313.0 Para. 3 — Inserted by Annex No 2 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).