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 Protection of Participants
Art. 11 Subsidiarity
1 A research project involving persons may only be carried out if equivalent findings cannot be obtained by other means. 2 A research project involving particularly vulnerable persons may only be carried out if equivalent findings cannot be obtained by other means.
Art. 12 Risks and burdens
1 In every research project, the risks and burdens for the participants must be minimised as far as possible. 2 The likely risks and burdens for the participants must not be disproportionate to the expected benefits of the research project.
Art. 13 Placebo
In research projects with an expected direct benefit, the use of a placebo or non‑treatment is only permissible if no additional risk of serious or irreversible harm is to be expected for the persons concerned and: no standard treatment is available; or the use of a placebo is required for compelling, scientifically sound methodological reasons, in order to establish the efficacy or safety of a treatment method.
Art. 14 Non-remunerative participation
1 No person may receive payment or any other non-cash advantage for participation in a research project with an expected direct benefit. Participation in a research project with no expected direct benefit may be appropriately remunerated. 2 No person may demand or accept payment or any other non-cash advantage from another in return for the latter’s participation in a research project.
Art. 15 Safety and protective measures
1 Anyone who conducts a research project must, before it begins, take all the measures required to protect the participants. 2 If, during the research project, circumstances arise which could jeopardise the safety or health of the participants or lead to a disproportionate relationship between the risks and burdens and the benefits, all the measures required to ensure protection are to be taken without delay.
Section 2 Information and Consent
Art. 16 Informed consent
1 Persons may only be involved in a research project if they have given their informed consent. Consent must be given in writing; the Federal Council may specify exemptions. 2 The persons concerned must receive comprehensible oral and written information on: a. the nature, purpose and duration of, and procedure for, the research project; b. the foreseeable risks and burdens; c. the expected benefits of the research project, in particular for themselves or for other people; d. the measures taken to protect the personal data collected; e. their rights. 3 Before a decision on consent is made by the persons concerned, they must be allowed an appropriate period for reflection. 4 The Federal Council may specify further elements of the information to be provided.
Art. 17 Consent to further use for research
If the intention exists to make further use for research of biological material sampled or health-related personal data collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they must be informed of their right to dissent.
Art. 18 Incomplete information
1 In exceptional cases, the persons concerned may be given incomplete information regarding individual aspects of a research project before it begins: a. insofar as this is essential for methodological reasons; and b. if the research project entails no more than minimal risks and burdens. 2 The participants must subsequently be duly informed as soon as possible. 3 Once they have been informed in accordance with paragraph 2, they may give or withhold their consent to the use of their biological material or their data. Only when such consent has been given is the biological material or data to be used for the research project.
Section 3 Liability and Coverage
Art. 19 Liability
1 Any person who carries out a research project involving persons shall be liable for damage suffered by them in connection with the project. The Federal Council may specify exemptions from liability. 2 Compensation claims prescribe in accordance with Article 60 of the Swiss Code of Obligations. The Federal Council may specify a longer prescriptive period for particular research areas. 3 The provisions of the Code of Obligations on tort are otherwise applicable; in the exercise of official duties, the Government Liability Act of 14 March 1958, or cantonal government liability law, is applicable.
Para. 2 — SR 220 Para. 2 — Amended by Annex No 17 of the FA of 15 June 2018 (Revision of the Law on Prescription), in force since 1 Jan. 2020 (AS 2018 5343; BBl 2014 235). Para. 3 — SR 170.32
Art. 20 Coverage
1 Liability must be appropriately covered through insurance or in some other manner. The Federal Government and its public-law institutions and corporations are exempt from the liability coverage requirements. 2 The Federal Council may: a. specify requirements for insurance and other forms of coverage; b. exempt research areas or classes of damage from the liability coverage requirements. 3 For the protection of the injured party, it may: a. grant this party a direct claim against the party providing liability coverage; b. restrict the cancellation rights and objections of the party providing liability coverage, while granting appropriate rights of recourse.