As part of departmental research efforts into research involving humans, the FOPH commissions studies on specific issues. The findings of these studies form the basis of the evaluation of the law. An overview of the projects so far can be found below.
- Quality and Transparency in Clinical Research
- Statistics and survey on the implementation of the Swiss Human Research Act (HRA)
- Costs of randomised clinical trials in Switzerland before and after enactment of the legislation on human research
- What the general public know and think about human research and the rules governing it
- The regulation of biobanks and health databases in Europe: A comparative law study
- Implementation of the requirements for further use of biological material and data
- Linguistic analysis of “comprehensibility” in research involving humans
- Rules governing damages and liability in human research
- Pilot study: categorisation of clinical trials
- Enforcement by the supervisory authorities before the entry into force of the Human Research Act (HRA)
- Updating the risk analysis
Quality and transparency in clinical research
Clearly structured and comprehensive trial protocols are essential to ensuring the quality of clinical trials, in particular with regard to the following aspects:
- Safety and welfare of participating persons
- Significance of the data obtained
- Successful completion of the trials
- Credibility of the findings
Incomplete protocols can have detrimental consequences for patients, decision-making processes in health policy, the scientific community and society as a whole.
The aim of the government research project was to compare approved randomised clinical trials from 2012 and 2016 (before and after the Human Research Act came into force). It looked at the effect of two separate elements on the correctness and completeness of trial protocols, namely the international recommendations for the minimum content of protocols (SPIRIT) and the Human Research Act. The project also examined the issue of transparency, in particular how many of the trials in the study were recorded in a register before being launched.
Statistics and survey on the implementation of the Swiss Human Research Act (HRA)
This three-part departmental research project, commissioned by the FOPH in collaboration with swissethics, enables for the first time a comprehensive quantitative description of projects involving research on humans and the corresponding legal regulation. It was conducted on the basis of the BASEC electronic submission system, which has been in operation since the beginning of 2016.
Overarching report covering all three sub-projects (statistics, survey and jurisdictional inquiries)
In this section the most important results of all three sub-projects were examined and set in context with each other.
Sub-project 1: Descriptive statistics on research within the scope of the Swiss Human Research Act
Research projects submitted to and approved by the cantonal ethics committees in 2016 and 2017, plus the processes used for approval and the times taken to process them, were described statistically on an aggregate basis and by various different characteristics. This was done using uniformly gathered structured data from BASEC, the ethics committee’s electronic system for submitting applications. This process will be repeated for the years 2018 to 2020 to provide statistics enabling a longer-term evaluation of the development of projects involving re-search on humans in Switzerland.
Sub-project 2: Survey of researchers on implementation of the Human Research Act
All researchers who used BASEC in the year 2017 to submit a project involving research on humans for approval were questioned about their attitudes and their experience with the legal regulations and the e-forcement of these regulations by the authorities responsible (cantonal ethics committees and Swissmedic).
Sub-project 3: Characteristics of jurisdictional inquiries
A survey of researchers who had submitted so-called jurisdictional inquiries (clarifications of responsibility) via BASEC was conducted. Thanks to this survey and an analysis of the documents submitted in connection with jurisdictional inquiries, it was possible to identify demarcation problems and uncertainty experienced by researchers in dealing with the regulations on research involving humans.
Costs of randomised clinical trials in Switzerland before and after enactment of the legislation on human research
A research team from the University of Basel was mandated by the FOPH to investigate the effects that the legislation on human research will have on the costs and workloads entailed by randomised clinical trials in Switzerland.
The individual cost components and time inputs required for planning and executing a clinical trial were listed in a standardised form. The result is a user-friendly tool that will assist clinical researchers in planning and carrying out their studies.
Despite intensive work, the study’s authors only succeeded to a very limited extent in allocating standard costs to the listed cost items and comparing the trial-preparation costs before and after enactment of the legislation on human research. This was attributed firstly to a lack of information about the clinical trials (especially with regard to industry-financed studies) and secondly to data-protection considerations.
The study’s authors found a discrepancy between the reported very high costs associated with randomised clinical trials on the one hand and the lack of transparent and valid evidence on the other. It is strongly recommended that tools be used to improve the planning and monitoring of costs and workloads involved in clinical trials.
Table for planning and monitoring of costs and workloads involved in clinical trials (copyright Speich et al 2019, PLOSone)
What the general public know and think about human research and the rules governing it
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. It 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.
The regulation of biobanks and health databases in Europe: A comparative law study
This report is a comparative law study on biobanks and health databases in Europe. It presents the legislation applicable in a number of European countries along with a range of international texts, such as the Taipei Declaration and the regulations of the European Union and the Council of Europe. A comparison is made by looking at topics related to the subject, such as biobank governance, participant protection, data protection and supervisory authorities. The main purpose of this study is to obtain an overview of the systems selected by the various countries, and of the advantages and disadvantages they entail.
Implementation of the requirements for further use of biological material and data
If data or biological material produced during the treatment of diseases or in research projects – i.e which is already available – is to be used for research purposes, certain requirements of the Human Research Act (HRA) must be observed. For example, persons from whom the data or samples originate must have agreed to their re-use, and research projects in which these data and projects are used must be approved by an ethics committee. The departmental research project investigated how researchers and licensing authorities implement the requirements of the HRA, how complex the implementation is, and what effects can be observed on re-use research.
Linguistic analysis of “comprehensibility” in research involving humans
People may only be involved in a research project if, among other requirements, they have given their informed consent. For this consent to be valid, the information provided must be “comprehensible” (Article 16 of the Human Research Act, HRA). The formal requirement that all documents containing information for participants must be comprehensible is therefore a fundamentally significant aspect of research involving humans. This departmental research project takes a linguistic look at how the comprehensibility requirement is implemented by researchers and oversight authorities.
The project consists of the following modules:
1. On the basis of a report surveying the available research literature, a methodological approach or “comprehensibility model” was developed as the foundation for analysis conducted in the subsequent sub-projects.
2. By way of a case study, the comprehensibility of the Model of General Consent 2017/1 (general consent model) published by the Swiss Academy of Medical Sciences (SAMS) and swissethics was evaluated.
3. Ethics committees must check the comprehensibility of documentation provided to potential participants. The third module shows what concepts of comprehensibility this check is based on for three selected ethics committees.
4. Researchers must inform people who are considering taking part in a research project. The fourth sub-project investigates researchers’ concepts and procedures concerning information.
The intention is to use the findings from these four projects to develop measures to further improve comprehensibility.
Rules governing damages and liability in human research
Only shortly after the Human Research Act (HRA) came into force, a motion was submitted to parliament (the Swiss National Council) calling for an amendment of the law reversing the burden of proof in favour of trial participants (subjects). According to the motion, the onus should be on the sponsor of the study to prove that there is no connection between the research procedure and the impairment suffered, rather than on the subject to prove that there is a connection between the two.
To get a thorough overview of the legal situation and the practical relevance of liability issues, the FOPH commissioned asim (the Swiss Academy of Insurance Medicine) at University Hospital Basel to investigate the issues related to the liability regime in practice, and in particular to undertake an international comparison of the question of burden of proof.
Pilot study: categorisation of clinical trials
The Human Research Act (HRA) has entailed a number of changes, one of the most important of which is a system for categorising research projects (risk classification). This system closely follows the approach to categorising projects recommended by the Organisation for Economic Co-operation and Development (OECD) and approved by that organisation in 2013. Before the HRA entered into force, the Clinical Trial Unit at the University of Bern conducted a scientific pilot study to test the categorisation approach.
Various countries and regions, including the European Union, are currently working on or implementing new rules for conducting clinical trials. They all take account of the system of categorisation recommended by the OECD. For this reason, the findings of the pilot study are attracting a great deal of international interest.
Enforcement by the supervisory authorities before the entry into force of the Human Research Act (HRA)
This departmental research project addresses the impact of the HRA on enforcement by the federal authorities cantonal ethics committees. The project takes the form of a before and after investigation.
INTERFACE Politikstudien Forschung Beratung GmbH examined the situation before the FRA entered into force by analysing data and documents and conducting guided interviews.
The investigation of the situation after entry into force is scheduled for 2017/18.
Overview of research involving humans in Switzerland
There is still no comprehensive description of research involving humans in Switzerland in its qualitative and quantitative totality. For this reason the Büro für Arbeits- und Sozialpolitische Studien (BASS) research bureau has been commissioned to draw up an overview of human research in Switzerland.
Updating the risk analysis
The Federal Constitution requires lawmakers to regulate certain research activities if, and only if, the related risks make this necessary. Some 20 years after parliament called for legislation, a project was therefore initiated to update the original risk analysis from a sociological perspective.
Last modification 03.10.2019