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.

The primary aim of the HRA is to protect people who make themselves available as “subjects” of research. A secondary aim is to assure a favourable framework for research involving humans. Ultimately it is designed to assure quality and transparency in human research.

The FOPH conducts individual departmental research projects to monitor the impact of the law. The findings of these projects go into an evaluation report addressed to the Federal Council. This forms the basis for any recommendations for improving the legislation.

Departmental research forms the basis

The departmental research commissioned by the FOPH addresses political, economic and social questions. It is practical, problem-oriented and as a rule interdisciplinary, functioning as an interface between science and practice. The findings of this research form the basis of subsequent evaluation.  

Evaluation to monitor impact

The evaluation serves to monitor the impact of government action. Evaluating efficacy in this way enables the FOPH to explain the actual social and economic impact of legislation on human research to politicians, the authorities and members of the public. For the purposes of the evaluation the FOPH combines the findings of departmental research projects, augmented if required with the findings of other studies. The resulting evaluation report forms the basis for any improvements to the law and accompanying ordinances.

Procedure

To generate material for evaluating the impact of the HRA, the Human Research and Ethics Section of the FOPH has initiated various departmental research projects between 2012 and 2019. Responsible for the evaluation conducted on this basis is the FOPH’s Evaluation and Research Service, which operates on a centralised basis independently of the specialist units. The Human Research and Ethics Section and Evaluation and Research Service communicate regularly and provide mutual support in the process of gathering information.

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.

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 03.10.2018

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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

Print contact

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