1Der Bund erlässt Vorschriften über die Forschung am Menschen, soweit der Schutz seiner Würde und seiner Persönlichkeit es erfordert. Er wahrt dabei die Forschungsfreiheit und trägt der Bedeutung der Forschung für Gesundheit und Gesellschaft Rechnung.
2Für die Forschung in Biologie und Medizin mit Personen beachtet er folgende Grundsätze:
a.
Jedes Forschungsvorhaben setzt voraus, dass die teilnehmenden oder gemäss Gesetz berechtigten Personen nach hinreichender Aufklärung ihre Einwilligung erteilt haben. Das Gesetz kann Ausnahmen vorsehen. Eine Ablehnung ist in jedem Fall verbindlich.
b.
Die Risiken und Belastungen für die teilnehmenden Personen dürfen nicht in einem Missverhältnis zum Nutzen des Forschungsvorhabens stehen.
c.
Mit urteilsunfähigen Personen darf ein Forschungsvorhaben nur durchgeführt werden, wenn gleichwertige Erkenntnisse nicht mit urteilsfähigen Personen gewonnen werden können. Lässt das Forschungsvorhaben keinen unmittelbaren Nutzen für die urteilsunfähigen Personen erwarten, so dürfen die Risiken und Belastungen nur minimal sein.
d.
Eine unabhängige Überprüfung des Forschungsvorhabens muss ergeben haben, dass der Schutz der teilnehmenden Personen gewährleistet ist.
Art. 118b Cst. governs research involving human beings in the fields of medicine and biology. This constitutional provision was adopted in 2010 with 77.2% approval and grants the Confederation comprehensive legislative authority over human research (BBl 2007 8045). At the same time, it protects the dignity and personality of research participants through binding principles.
Who is affected? The provision covers all persons who participate in medical or biological research — from patients in clinical trials to healthy volunteers in prevention studies (Art. 2 HRA). Research involving biological materials and health data also falls under this provision. Persons lacking capacity of judgment (children, persons with dementia) enjoy special protection (Art. 118b para. 2 lit. c Cst.; Art. 22 HRA).
What are the legal consequences? All human research requires authorisation from an ethics committee (Art. 45 HRA). Researchers must provide comprehensive information to participants and obtain their written consent (Art. 16 HRA). This consent may be withdrawn at any time. Violations are punishable by imprisonment of up to three years (Art. 62 HRA). Belser/Molinari emphasise that the constitutional provision "acts as a constitutional specification of the fundamental rights tension between freedom of research and protection of personality" (Belser/Molinari, BSK BV, Art. 118b N. 1).
Example: A pharmaceutical company wants to test a new cancer drug. It must submit the study protocol to an ethics committee, take out insurance (Art. 20 HRA) and inform each patient about risks and benefits. The study is publicly registered (Art. 56 HRA). Research may only begin after a positive ethics assessment and written patient consent. The Federal Supreme Court clarified: "There is a public interest in protecting human dignity, personality and health in research" (BGer 2C_885/2018 E. 4.3).
The constitutional provision balances freedom of research and human protection. It enables medical progress under strict ethical conditions and creates uniform standards throughout Switzerland through the Human Research Act (HRA; SR 810.30), which came into force in 2014.
N. 1 Art. 118b Cst. was adopted on 7 March 2010 by the people and cantons with 77.2% yes votes. The provision originates from the parliamentary initiative of the Council of States' Committee for Science, Education and Culture dated 29 January 2004 (BBl 2007 8045). The Federal Council supported the proposal, but emphasised the necessity of a careful balance of interests between research freedom and protection of personality (BBl 2007 8059 ff.).
N. 2 The initiative responded to the heterogeneous cantonal regulatory landscape in the field of human research. Before 2010, international standards such as the Declaration of Helsinki (1964/2008) and the ICH-GCP guidelines existed, but there was no coherent national legal basis. The dispatch stated: «The current legal situation is characterised by great heterogeneity in the density of norms, hierarchy of norms and legal bases» (BBl 2007 8052).
N. 3 The constitutional legislator deliberately chose comprehensive federal competence, combined with substantive protective mandates. This was intended to both guarantee research freedom and ensure protection of test subjects (BBl 2007 8060).
N. 4 Art. 118b Cst. is systematically placed between the provisions on transplantation medicine (Art. 119a Cst.) and on reproductive medicine and genetic technology in the human field (Art. 119 Cst.). This classification shows the close connection with other biomedical regulatory areas.
N. 5 The norm has strong connections to fundamental rights: Research freedom (→ Art. 20 Cst.) is limited by protective duties in favour of human dignity (→ Art. 7 Cst.) and personal freedom (→ Art. 10 Cst.). Belser/Molinari emphasise that Art. 118b Cst. «represents a constitutional specification of the fundamental rights tension between research freedom and protection of personality» (Belser/Molinari, BSK BV, Art. 118b N. 1).
N. 6 In relation to other constitutional provisions, the demarcation from Art. 119 Cst. is particularly relevant. While Art. 119 Cst. regulates the application of genetic engineering procedures, Art. 118b Cst. covers the upstream research. Belser/Molinari state: «Art. 118b Cst. covers research in all areas of health, including reproductive and transplantation medicine» (Belser/Molinari, BSK BV, Art. 118b N. 14).
N. 7Research on humans: According to the Federal Council, the term encompasses «any systematic search for generalisable knowledge» (BBl 2007 8058). The demarcation from medical practice is made according to purpose: If knowledge acquisition is in the foreground, research exists; if the activity primarily serves the patient, it constitutes treatment (BBl 2007 8058). Schweizer specifies: «The finality of the activity is decisive» (Schweizer, Recht der Forschung im Gesundheitsbereich, 2008, p. 380).
N. 8Field of medicine and biology: The norm covers not only clinical trials, but all research with health-related knowledge objectives. This includes epidemiological studies, research with biological materials and health-related data as well as psychological research with health relevance (Rütsche, Die Neuordnung des schweizerischen Humanforschungsgesetzes, ZSR 2010 I 405).
N. 9Protection of dignity and personality: These terms refer to the fundamental rights in Art. 7 and 10 Cst. Human dignity sets absolute limits to research; personality can be restricted under the conditions of Art. 36 Cst. (Belser/Molinari, BSK BV, Art. 118b N. 25-28).
N. 10Legislative mandate: Art. 118b para. 1 sentence 1 Cst. establishes comprehensive federal competence for regulating research on humans. This was exercised through the Human Research Act of 30 September 2011 (HRA; SR 810.30), which came into force on 1 January 2014.
N. 11Direct applicability: According to Belser/Molinari, the principles mentioned in para. 2 are «directly applicable as minimum standards» (Belser/Molinari, BSK BV, Art. 118b N. 30). They bind the legislator and can be used in interpreting the HRA.
N. 12Protective duties: The state must actively protect dignity and personality in research. This includes preventive measures (licensing requirements), controls (ethics committees) and sanctions (Gächter/Rütsche, Gesundheitsrecht, 3rd ed. 2013, N. 872).
N. 13Scope of federal competence: Belser/Molinari represent the position of comprehensive federal competence, which is however substantively limited by protective mandates: «Federal competence is to be understood as comprehensive, but the Confederation cannot exercise it in any arbitrary manner» (Belser/Molinari, BSK BV, Art. 118b N. 11). In contrast, van Spyk and Rütsche qualify Art. 118b para. 1 as «risk-related federal competence», which is oriented towards the need for protection (van Spyk, Grundlagen und Reichweite der neuen Bundeskompetenz, AJP 2010, 210; Rütsche, ZSR 2010 I 408).
N. 14Relationship to Art. 119 Cst.: The demarcation between research (Art. 118b Cst.) and application (Art. 119 Cst.) in the field of reproductive medicine is disputed. Belser/Molinari advocate for comprehensive application of Art. 118b Cst. to all research, including in the field of reproductive medicine (Belser/Molinari, BSK BV, Art. 118b N. 14). Rütsche, however, differentiates: «Art. 119 Cst. takes precedence as the more specific norm, insofar as it regulates research on embryos» (Rütsche, ZSR 2010 I 409). Sprecher supports this differentiated view with the argument of systematic coherence (Sprecher, Medizinische Forschung mit Kindern und Jugendlichen, 2007, p. 89).
N. 15Research with persons lacking capacity to consent: The admissibility requirements of Art. 118b para. 2 lit. c Cst. are the subject of intensive debates. van Spyk represents a restrictive interpretation: «Research serving the interests of others on persons lacking capacity to consent is only permissible with minimal risk» (van Spyk, AJP 2010, 215). Brauer advocates for more flexibility under strict protective precautions: «A categorical prohibition would exclude vulnerable groups from medical progress» (Brauer, Der Einfluss der Ethik auf das Recht, ZSR 2010 I 452). The NEK-CNE takes a mediating position (Opinion No. 25/2015).
N. 16Licensing requirement: Every research project on humans requires prior approval by a recognised ethics committee (Art. 45 HRA). The application must be submitted at least 30 days before project commencement (Art. 30 ClinO; SR 810.305).
N. 17Informed consent: Informed consent must be given in writing and must be revocable at any time (Art. 16 HRA). For persons lacking capacity to consent, the consent of the legal representative is required (Art. 22 HRA).
N. 18Insurance obligation: For clinical trials, obligatory liability insurance or equivalent security exists (Art. 20 HRA in conjunction with Art. 13-15 ClinO).
N. 19Registration: Clinical trials must be entered in a public register (Art. 56 HRA). This applies before recruitment of the first test subject.
N. 20Subsidiary application of cantonal law: Insofar as the HRA contains no regulation, cantonal law remains applicable, particularly for the organisation of ethics committees (Art. 51 HRA; BGer 2C_885/2018 E. 3.2).
BGer 2C_885/2018 of 12 November 2018
The Federal Supreme Court confirmed the position of cantonal ethics committees as central actors in the implementation of Art. 118b FC. The proceedings concerned the approval for the continued use of data from a double-blind study by the Cantonal Ethics Committee Bern. The court held that ethics committees act in the public interest and that their decisions are in principle subject to review.
«There is a public interest in protecting the dignity, personality and health of humans in research (cf. Art. 118b FC; cf. Art. 1 of the Federal Act of 30 September 2011 on Research involving Human Beings [HRA; SR 810.30]).»
BGer 2A.450/2002 of 4 July 2003
Early case law on the organisation of cantonal ethics committees before the Human Research Act entered into force. The proceedings concerned the recognition and approval of an ethics committee in the Canton of Basel-Landschaft for clinical trials. The judgment already clarified the constitutional foundations for the ethical control of research on humans.
BGE 134 IV 175 of 24 April 2008
Landmark judgment on criminal duties of care in the experimental use of medicinal products. The proceedings concerned the fatal use of a cancer medication without proper authorisation. The Federal Supreme Court clarified that criminal duties of care in the experimental use of medicinal products are governed by the provisions on clinical trials, which are however only applicable to systematic research investigations, not to individual therapeutic experiments.
«The criminal duties of care in the experimental use of a medicinal product are governed by the provisions on clinical trials with therapeutic products (Art. 53 ff. TPA). However, the provisions are only applicable to systematic research investigations and not to individual therapeutic experiments.»
BGer 2C_537/2022 of 25 January 2024
Recent judgment on the application of the Ordinance on Clinical Trials in Human Research (ClinO). The proceedings concerned the adaptation of medicinal product information. The court confirmed that clinical trials concerning medicinal products must be conducted according to the rules of Good Clinical Practice.
Urteil AG Strafgericht SST.2023.306 of 17 December 2024
Significant judgment on the distinction between legitimate criticism of research practices and defamatory accusations. The proceedings concerned accusations against a doctor regarding allegedly unethical research on humans. The court held that there is a public interest in compliance with provisions for research on humans, but excessive accusations can be prosecuted under criminal law.
«There is a public interest in protecting the dignity, personality and health of humans in research (cf. Art. 118b FC; cf. Art. 1 of the Federal Act of 30 September 2011 on Research involving Human Beings [HRA; SR 810.30]). If a doctor does not comply with the provisions for research on humans, e.g. regarding consent after adequate information or research with persons lacking capacity to consent (Art. 118b para. 2 lit. b and d FC; Art. 7, 16 ff. and 24 HRA), [...] there is in principle sufficient cause to report this to the employer or the competent authorities.»
BE GSI 2022.GSI.2729 of 3 March 2023
Recent case law on transparency in research on humans. The proceedings concerned a request for access to files regarding data held by an ethics committee. The lower court confirmed that the legislator has introduced a registration requirement for clinical trials with the aim of transparency.
«With the aim of ensuring transparency in research on humans (Art. 1 para. 2 lit. c HRA), the legislator has introduced a registration requirement for clinical trials (Art. 56 HRA).»
Case law on Art. 118b FC is not yet very extensive, as the provision only entered into force in 2010 and the Human Research Act followed in 2014. The available decisions focus on the role of ethics committees, the distinction between research and therapeutic experiments, and the enforcement of ethical standards. The courts consistently emphasise the constitutional mandate to protect human dignity in research while safeguarding freedom of research.