Evaluation of the Human Research Act

The Federal Office of Public Health ordered an analysis of the effectiveness of the Human Research Act (HRA). The results of the evaluation form the basis for several proposals for improvement.

As part of the evaluation, the FOPH analysed over the course of the past few years the specific effects of the Human Research Act. The question at the core of the evaluation was whether the aims of the HRA are being achieved: primarily the protection of research participants and of persons who make their health-related data or their blood or tissue samples available for research. On the other hand, the HRA is also intended to create favourable conditions for human research. And, last but not least, it aims to help ensure quality and transparency in human research. The FOPH’s centralised “Evaluation and Research Service”, which is independent of the main units, was in charge of the evaluation; it commissioned the Institute of Political Science of the University of Zurich, in collaboration with KEK-CDC Consultants, with carrying it out.

In addition to the evaluation team’s own surveys, the evaluation report for the attention of the Federal Council also includes the results of individual research projects, the so-called “departmental research projects”. These projects were instigated by the FOPH’s Human Research Section between 2012 and 2019.
The evaluation report concludes that the human research regulations are fundamentally appropriate but that there is room for improvement. It specifies 13 recommendations.

The FOPH has evaluated the results of the evaluation and submitted several proposals for further action to the Federal Council (see FOPH report). On 6 December 2019, the Federal Council acknowledged the results of the evaluation and decided to undertake a partial revision of the HRA’s ordinance legislation. A bill for consultation is to be made available to the Federal Council in 2022. At the same time, measures to improve enforcement are to be defined and implemented in coordination with the cantons and the enforcement authorities.

The following items will be at the centre of the ordinance legislation’s planned revision:

  • with regard to organising implementation, the tasks and powers of the enforcement authorities;
  • in the context of research with health-related personal data and biological material, information for and consent from affected persons;
  • with regard to international developments, EU legislation; and finally
  • transparency in the context of the publication of research results.

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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 03.08.2021

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Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Bern
Tel. +41 58 463 51 54

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