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.

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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:

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.

The evolution of human research legislation

The federal legislation on human research replaces a confusing and incomplete array of different laws, implementing an article of the Federal Constitution that allows the Confederation to enact rules governing research.

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 Federal Office of Public Health is responsible for evaluating the efficacy of the Human Research Act (HRA). The results of this evaluation form the basis of any suggested improvements.

Clinical trials on medicinal products for human use in the EU

From 2019 there will be new regulations in the EU governing clinical trials on medicinal products. The FOPH is assessing the impact of these new rules on research in Switzerland and closely monitoring further developments.

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.

Legislation

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.

Last modification 17.08.2018

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
E-mail

The FOPH operates the Coordination Office for Human Research (kofam)

www.kofam.ch

E-mail

Print contact

https://www.bag.admin.ch/content/bag/en/home/medizin-und-forschung/forschung-am-menschen.html