The evolution of human research legislation

In 2014, federal legislation on human research replaced a confusing and incomplete array of different laws, implementing Article 118b of the Swiss Federal Constitution, under which the Confederation may enact national legislation governing research.

Constitutional basis

Switzerland’s legislation on research involving humans goes back to a motion in parliament in 1998 calling for a uniform regulatory framework to be created at federal level to replace a confusing and sometimes inconsistent array of federal and cantonal laws. The aim was to safeguard human rights while at the same time not impeding meaningful research on human beings.

To give the Confederation comprehensive authority to regulate human research under the federal system of governance, in 2003 there was a motion in parliament commissioning the formulation of a corresponding new constitutional norm. The new article of the Federal Constitution of the Swiss Confederation, 118b on research on human beings, was passed by parliament on 25 September 2009. It was accepted on 7 March 2010 with 77.2% of citizens and all the cantons voting yes.

Article 118b of the federal constitution grants the Confederation the power to legislate on research on human beings where – and only where – this is required to protect the dignity, privacy and health of people involved in research. Secondarily the Confederation should preserve the freedom to conduct research and take account of the importance of research to health and society. Article 118b also lays down principles in relation to biological and medical research involving humans. Participants must always give their informed consent; the risks and stress for the participants must not be disproportionate; special protective safeguards must be in place for research involving people lacking the capacity to consent (for example children); and all research projects have to be assessed independently to determine whether the safety of participants is guaranteed.

The Human Research Act

The Federal Act on Research involving Human Beings (Human Research Act or HRA for short) was drafted parallel to, and concretises, Article 118b of the constitution. The law is designed to safeguard the dignity, privacy and health of people involved in research. Provided protection is afforded, the law is also designed to create favourable conditions for research involving human beings and ensure quality and transparency.

In line with the constitutional basis and the goal of comprehensive regulation, the law defines the term “research involving humans” broadly. In addition to research involving persons, it also covers research involving biological material of human origin, personal data, deceased persons, and human embryos and foetuses.

The Human Research Act was passed by parliament on 30 September 2011. The Council of States approved it unanimously, and the National Council voted 189 to 7 in favour. The act entered into force along with the accompanying ordinances on 1 January 2014.

Implementing ordinances

The implementing ordinances accompanying the Federal Human Research Act lay down more precisely the ethical, scientific and legal requirements that have to be taken into account when conducting research on human beings. They build on the risk-adapted approach to regulation adopted in the federal constitution and law.

There are four implementing ordinances: the Clinical Trials Ordinance (ClinO), the Ordinance on Clinical Trials with Medical Devies (ClinO-MD), the Human Research Ordinance (HRO) and the HRA Organisation Ordinance (OrgO-HRA).

Documents

Note: Explanatory reports on the ClinO-MD, its adaptation in the context of the non-updating of the MRA, as well as its adaptation due to the enactment of the IvDO can be found on FOPH's internet site Revision of Swiss medical devices legislation under "Documents".

• Verfassungsartikel über die Forschung am Menschen (in German) (PDF, 465 kB, 30.04.2010)
• Botschaft zum Verfassungsartikel über die Forschung am Menschen (PDF, 618 kB, 12.09.2007)
• Botschaft zum Entwurf eines Bundesgesetzes über die Forschung am Menschen (in German) (PDF, 828 kB, 07.12.2009)
• Erläuternder Bericht (in German) (PDF, 513 kB, 19.09.2013)Erläuternder Bericht über die Verordnungen zum Humanforschungsgesetz

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• KMU-Verträglichkeitstest (in German) (PDF, 1 MB, 19.11.2009)
• Regulierungsfolgenabschätzung (in German) (PDF, 2 MB, 19.09.2013)Regulierungsfolgenabschätzung zum Entwurf des Ausführungsrechts des Humanforschungsgesetzes (HFG)
• Überblick über die Humanforschung in der Schweiz (in German) (PDF, 1 MB, 15.10.2013)Schlussbericht vom 30. August 2013

Links

• 03.3007 - Motion on research on humans, constitutional basis
• 07.072 – Federal Council business, constitutional provision
• 98.3543 - Motion to create a federal law on medical research involving humans
• 09.079 - Federal Council business: research involving humans, federal act
• Bericht über die Ergebnisse des Vernehmlassungsverfahrens zum Vorentwurf einer Verfassungsbestimmung und eines Bundesgesetzes über die Forschung am Menschen (only in German, French and Italian)

Legislation

Last modification 24.05.2022