Research involving humans

The term “research involving humans” refers to scientific research in areas such as medicine, psychology and biology. 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 applying it continues to lie 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.

In essence the Human Research Act and accompanying ordinances significantly improve clarity and transparency by comparison with the various cantonal and federal rules that used to apply. They do much to assure the necessary improvements in professionalism and quality in this important but risky area of society.

Role of the FOPH

The FOPH’s main 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.

Coordination Office for Human Research

The Coordination Office for Human Research (kofam) ensures that the ethics committees and other supervisory authorities are coordinated and communicate. It also informs the public about the work of the ethics committees.

Evaluation of the Human Research Act

The Human Research Act was evaluated between 2017 and 2019. While its provisions are essentially fit for purpose, there is a need for improvements in a number of areas.

Clinical trials on medicinal products for human use in the EU

As of January 31, 2022, new regulations for clinical trials of medicinal products will become effective in the EU/EEA area. This change does not directly affect the conduct of clinical trials with medicinal products in Switzerland.

Portal for clinical trials in Switzerland (SNCTP)

Clinical trials in Switzerland must be published on the research portal. The online portal has been redesigned to facilitate this procedure. The portal can be found on the website of the Portal for Human Research (www.kofam.ch), which is operated by the FOPH.

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.

Current legislative project: Revision of Ordinances

The implementing provisions for the Human Research Act are being revised by the FOPH. The HRA Ordinances are being adapted 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.