Departemental research undertaken by the Human Research and Ethics section examines what impact the law has on specific areas of human research. The findings from individual research projects flow into the evaluation of the Human Research Act (HRA).
Protection of human beings
Analysis of the legal provisions concerning informed consent in human research
A key element in the conduct of human research projects is the provision of information about the project so that the person concerned can make an informed decision on whether to participate. Information must be provided in a comprehensible manner, as comprehensibility is the essential prerequisite for legally valid informed consent. This study investigated, from a linguistic perspective, how the comprehensibility requirement specified in the Act is implemented in practice.
Analysis of the regulation of damage and liability in human research
The Human Research Act regulates questions of liability in the event of project-related damage. In Switzerland, strict liability is applicable for research projects. This study compares legal liability provisions in eight European countries, assesses current practice in Switzerland and identifies areas where action may be required.
The primary goal of the Human Research Act and its implementing ordinances is to protect the dignity, privacy and health of human beings involved in research. In light of this, it is essential for reviews of the efficacy of the Act’s provisions to take on board the experience and perceptions of people who have taken part in clinical trials. The survey will ask participants why they chose to enrol in a clinical trial and about their experiences in the trial. The findings will help to improve the legal provisions and their implementation.
Analysis of the costs associated with the authorisation and conduct of clinical trials
One of the goals of human research legislation is to create favourable conditions for human research by standardising legal requirements throughout Switzerland and harmonising them with international guidelines. This longitudinal study analysed how the human research regulations affect the costs associated with the conduct of clinical trials. In particular, it compared the costs of preparing and conducting randomised clinical trials before and after the introduction of the HRA.
Analysis of the effects of the HRA on research involving health-related data and biological material
The human research legislation in force since 2014 also regulates research involving health related personal data and biological material from persons. Various studies were conducted to analyse, as comprehensively as possible, the effects of the HRA on this type of research and also in relation to the approval authorities. The studies focused not only on costs but on key aspects of the protection of privacy, especially data protection.
Description of the approval process for clinical trials: statistics and survey
Following the implementation of the new Human Research Act in 2014, the cantonal ethics committees developed a computerised system for handling submission and approval processes. Researchers have been able to use the system to submit applications since 1 January 2016. This investigation used the system’s structured data to produce a statistical description of the research projects that have been submitted and approved in the course of a year. In addition, people who have submitted a research project via the system were surveyed on the effectiveness of human research legislation in general and the submission and approval process in particular.
Analysis of the requirements of human research legislation with regard to quality and transparency in clinical research
This study compares two cohorts from randomised clinical trials approved in Switzerland in 2012 and 2016 (i.e. before and after the introduction of the HRA). Firstly, based on international standards, the correctness and completeness of the trial protocols submitted to the approval authorities are assessed and compared. Secondly, it investigates to what extent the trials were registered, whether they were conducted as planned and whether the results were published. Because of the duration of the trials approved in 2016, this part of the study is not expected to be completed before 2023.
Analysis of how the new EU Regulation on clinical trials on medicinal products will affect Switzerland as a research location
The Regulation on clinical trials on medicinal products for human use (EU No 536/2014) is expected to come into force at the end of 2020. By means of a prospective regulatory impact analysis, the effects on Switzerland as a research location were investigated. A risk assessment was also carried out and reference made to any need for action.
What the general public know and think about human research and corresponding rules
On 7 March 2010, the Swiss population voted in favour of the constitutional article governing human research by a substantial majority of 77.2%. This indicates that the country’s citizens felt it was important to have national legislation to govern research on humans. However, surveys carried out after the referendum showed that some voters had a somewhat sketchy knowledge of the purpose and content of the legislation in question. This study reflects how much people in Switzerland know about human research and the laws governing it and what their attitudes are eight years down the line. The survey was carried out between March and May 2018. The aim was to discover how much Swiss citizens know about research involving humans in their country, whether they feel adequately protected by the current legislation, and whether they would be willing to take part in research projects.
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.