Research involving humans

The term “research involving humans” refers to scientific research in areas such as medicine, psychology and biology and is regulated by law in Switzerland. The main goal is to safeguard people, their dignity, privacy and health.

Benefits and risks of research involving humans

In addition to basic research, "research involving humans" focuses especially on understanding the causes of diseases and improving treatment options.

Research involving humans is of huge importance for our society, and has a bearing on personal and public health, the training of medical professionals, and diverse sectors of the economy.

But research involving humans also entails risks. For example people who make themselves available for tests of a new drug may suffer damage to their health. Another important consideration is that data gathered in the course of research relates to people’s physical characteristics and health, and therefore has to be subject to special safeguards.

For these reasons, research involving humans is governed by federal legislation. The main aim is to safeguard the health and rights of people taking part in research. A secondary aim of the regulations is to create a favourable framework for research and help assure quality and transparency.

An overview of the legislation

Since 1 January 2014 there has been a unified and comprehensive framework governing research involving humans, in the form of the Swiss Federal Human Research Act and its accompanying ordinances. While the legislation is at federal level, the main responsibility for enforcing it lies with the cantons. In particular, cantonal ethics committees examine all projects involving research on humans before they are launched. In Switzerland, research involving humans can only be conducted with the authorisation of a cantonal ethics committee. Specific research projects involving drugs or medical devices also have to be reviewed and approved by Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products.

An evaluation conducted between 2017 and 2019 showed that overall, the law had achieved its goals. However, it also concluded that it needed to be reviewed in certain areas, and to this end formulated recommendations.

As the first step in responding to these recommendations, in December 2019 the Federal Council charged the Federal Department of Home Affairs (FDHA) with a partial revision of the implementing legislation related to the Human Research Act (HRA).

On 7 June 2024 the Federal Council approved and adopted the amendments to the implementing ordinances. At the same time the Federal Council charged the FDHA with revising the HRA and submitting a draft act by the end of 2026.

Further information on the revision of the ordinances can be found on the site "Completed legislative project: Revision of Ordinances" site.

Role of the FOPH

The FOPH’s role is to help ensure efficient, uniform application of the law by coordinating the activities of the various approval bodies. It is also responsible for reviewing and evaluating the efficacy of the legal regulations. The FOPH is also in charge of generally keeping the law up to date. In particular this involves monitoring scientific and technical developments, and developments in domestic and international policy and their impact on current law.

The FOPH has separate websites with detailed information on the following areas related to the topic:

Further information

Regulation of human research in Switzerland

Research involving human beings in Switzerland is regulated by the Human Research Act and the four associated Ordinances.

Tasks of the FOPH: information and coordination

The FOPH informs the public about research involving humans and manages the Coordination Office for Human Research. The office coordinates the various supervisory authorities and ensures smooth communication between them.

Which clinical trials are taking place in Switzerland?

Key information on clinical trials is accessible in the SNCTP (Swiss National Clinical Trials Portal). The portal is on the website www.kofam.ch.

Departmental research projects on the Human Research Act

As part of departmental research efforts into human research the FOPH commissions studies on specific issues. The findings form the basis of the evaluation of the law. An overview of the projects so far can be found here.

Concluded legislative project: Revision of Ordinances

The implementing provisions for the Human Research Act have been revised by the FOPH. It has adapted the HRA Ordinances in line with national and international developments in human research.

Links
Legislation

The portal of the Federal Office of Public Health (FOPH) for human research in Switzerland

Human research legislation

In Switzerland, research involving humans is governed by the Human Research Act and its implementing ordinances. The legislation is primarily designed to safeguard the dignity, privacy and health of people involved in research.