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.

In the evaluation carried out between 2017 and 2019, the FOPH investigated the effectiveness of the Human Research Act (HRA) over the first few years after its entry into force. The evaluation focused on the question whether the aims of the HRA – protecting the dignity, privacy and health of participants, creating favourable conditions for human research, and ensuring quality and transparency – are being achieved.

Responsibility for the evaluation lay with the FOPH Evaluation and Research Service – a centralised body independent of the specialised units – which commissioned the Zurich University Department of Political Science and KEK-CDC Consultants to conduct the evaluation.

Since 2012, so-called departmental research projects on the regulation of human research have been carried out on behalf of the FOPH Human Research Section. The results of these projects (for an overview, see Departmental research projects on the Human Research Act) were taken into account in the evaluation, as well as the evaluation team’s studies.

The evaluation report, published at the end of 2019, concludes that the provisions of the HRA are essentially fit for purpose, but that there is room for optimisation. To this end, 13 recommendations are formulated (see “Evaluation des Evaluation of the Human Research Act (HRA): Summary” under “Documents”).

The FOPH assessed the results of the evaluation and, on this basis, submitted proposals for further action to the Federal Council (see “FOPH report” under “Documents”). On 6 December 2019, the Federal Council took note of the results of the evaluation and decided that, as proposed by the FOPH, a partial revision of the Ordinances associated with the HRA should be undertaken.

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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.

Further information

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.

Last modification 25.04.2023

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Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Bern
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