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.
Section 1 Purpose, Scope and Definitions
Art. 1 Purpose
1 The purpose of this Act is to protect the dignity, privacy and health of human beings involved in research. 2 It is also designed to: a. create favourable conditions for research involving human beings; b. help to ensure the quality of research involving human beings; c. ensure the transparency of research involving human beings.
Art. 2 Scope
1 This Act applies to research concerning human diseases and concerning the structure and function of the human body, which involves: a. persons; b. deceased persons; c. embryos and foetuses; d. biological material; e. health-related personal data. 2 It does not apply to research which involves: a. IVF embryos in accordance with the Stem Cell Research Act of 19 December 2003; b. anonymised biological material; c. anonymously collected or anonymised health-related data.
Para. 2 let. a — SR 810.31
Art. 2a Applicability of the Federal Act on Human Genetic Testing
After consulting the Federal Commission for Human Genetic Testing, the Federal Council may in accordance with Article 54 of the Federal Act of 15 June 2018 on Human Genetic Testing (HGTA) declare that the HGTA applies to research involving human beings in the following fields: a. genetic counselling; b. avoiding surplus information and handling such information; c. genetic testing on persons lacking capacity of judgement; d. prenatal testing; e. conducting genetic testing and handling genetic data in connection with employment and insurance matters and in personal civil liability cases.
Art. 2a — Inserted by Annex No II 3 of the FA of 15 June 2018 on Human Genetic Testing, in force since 1 Dec. 2022 (AS 2022 537; BBl 2017 5597). SR 810.12
Art. 3 Definitions
In this Act: a. Research means method-driven search for generalisable knowledge; b. Research concerning diseases means research on the causes, prevention, diagnosis, treatment and epidemiology of impairments of physical and mental health in human beings; c. Research concerning the structure and function of the human body means basic research, in particular on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and impacts on the human body; d. Research project with an expected direct benefit means a research project whose results can be expected to improve the health of the participants; e. Biological material means bodily substances derived from living persons; f. Health-related personal data means information concerning the health or disease of a specific or identifiable person, including genetic data; g. Genetic data means information on hereditary properties or properties acquired during the embryonic phase obtained by genetic testing;
let. g — Amended by Annex No II 3 of the FA of 15 June 2018 on Human Genetic Testing, in force since 1 Dec. 2022 (AS 2022 537; BBl 2017 5597). let. l — Repealed by Annex of the FA of 22 March 2019, with effect from 26 May 2021 (AS 2020 2961; BBl 2019 1).
Section 2 Principles
Art. 4 Primacy of individual interests
The interests, health and welfare of the individual human being shall prevail over the interests of science and society.
Art. 5 Scientifically relevant topic
Research involving human beings may only be carried out if it addresses a topic of scientific relevance concerning: the understanding of human diseases; the structure and function of the human body; or public health.
Art. 6 Non-discrimination
1 Nobody is to be subjected to discrimination in connection with research. 2 With regard to the selection of participants in particular, no group of persons shall be disproportionately included in or excluded from research without good reason.
Art. 7 Consent
1 Research involving human beings may only be carried out if, in accordance with the provisions of this Act, the persons concerned have given their informed consent or, after being duly informed, have not exercised their right to dissent. 2 The persons concerned may withhold or revoke their consent at any time, without stating their reasons.
Art. 8 Right to receive information
1 The persons concerned are entitled to be informed of results relating to their health. The information is to be communicated in an appropriate manner. The persons concerned may choose to forgo such information. 2 They are entitled to be informed about all the personal data held in relation to them.
Art. 9 Prohibition of commercialisation
1 It is prohibited to offer, grant, demand or accept payment or any other non-cash advantage in exchange for the human body or parts thereof as such. 2 It is also prohibited to use the human body or parts thereof if they have been subject to a prohibited act as specified in paragraph 1.
Art. 9 — 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).
Art. 10 Scientific requirements
1 Research involving human beings may only be carried out if: a. the recognised regulations concerning scientific integrity are complied with, in particular with regard to the handling of conflicts of interest; b. scientific quality requirements are met; c. the recognised international Good Practice guidelines for research involving human beings are complied with; and d. the persons responsible have appropriate professional qualifications. 2 The Federal Council shall specify which national and international regulations must be complied with.