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Patient Involvement in an All-inclusive Societal Approach to Animal Research Ethics, Policy and Oversight

Research Project | 1 Project Members

In most countries, including Switzerland, all non-human animal-based experiments are submitted to animal experimentation oversight bodies to evaluate their scientific relevance relative to animal welfare concerns (harm-benefit analysis) and decide whether they should proceed. Within the framework of the harm-benefit analysis (HBA), animal research may thus be justified by legitimate interests of society, in particular, human medical and healthcare advancement. However, patients, who are generally cited as the end beneficiaries of biomedical research using animals, have had little say in animal research ethics, policy, regulation, and the licensing of animal research projects. This project aims to understand and ethically analyse the current decision-making process and decision criteria of the HBA. It also aims to identify legitimate decision criteria from a diverse stakeholder perspective, including people affected by health conditions. Finally, it aims to explore patient and public involvement (PPI) as a notion in animal research endeavours to clarify the decision criteria. The project uses mixed methods: first, a comprehensive analysis of the literature to understand and analyse the current decision-making process, followed by the use of a combination of quantitative and qualitative (online surveys with qualitative components and focus groups) methodologies to collect novel data from diverse stakeholders (scientists, patients, students, the general public and members of oversight bodies) in Swiss society. Since limited openness about animal research evaluation is believed to undermine public trust, this research will create awareness by bringing the discussion about animal research to Swiss society. In effect, clarifying decision criteria by involving diverse groups of stakeholders will increase public trust in the regulation and evaluation of animal research. Finally, exploring the aspects of patients’ involvement in oversight bodies will push the boundaries of PPI in preclinical research and contribute to the public debate about the legitimacy of animal research, paving the way for more societally acceptable and agreeable policies regarding animal experimentation.

Developing Ethics for Automation: New Paradigms of Equity & Trust

Research Project | 4 Project Members

Background and Rationale
As technological advancements accelerate and automation – particularly artificial intelligence (AI) – continues to progress at an unprecedented pace, we witness not only the transformation of industries but also profound changes in our daily lives. However, as these technologies become increasingly integrated into society, they also give rise to significant ethical concerns.
Automated systems can be integrated into society in a way that conforms with pre-existing societal paradigms (including trust, explainability and privacy), or in accordance with new paradigms that may prove more ethical, given the potential benefits of automation. When a trade-off is required to achieve efficiency (sacrificing data privacy, for instance), we must learn what level of compromise is acceptable, or desirable. In this research, we investigate two key questions: What is fairness in the context of automation? And how should existing ethical paradigms, including trust, explainability and privacy, be modified for automated systems?

Objectives and Aims
This project aims to investigate the implications of public opinion and automation literacy on the ethics of automation, and on public behaviour across various contexts.
In order to achieve its aim, the project will:
Explore the relationship between automation literacy, trust, explainability and data privacy
Investigate the effects of automation transparency, as well as increased automation literacy, among end-user behaviour
Evaluate existing fairness models in automation so as to refine and extend their application to diverse contexts
Examine public opinion on fairness in automation across various contexts.
Examine public opinion on data privacy and explore methods for public data sharing to enhance the efficiency of automated systems while ensuring compliance with consent and data protection standards.

Methods
This study will adopt a mixed methods approach. Qualitative data will be collected through semi-structured interviews with individuals from the general Swiss public and focus groups with experts from different fields (healthcare, energy systems, transportation) to explore public views and attitudes, as well as the influence of automation literacy on ethical considerations in automation. Building on these insights, a nationwide quantitative survey will be designed to target Swiss citizens.

THINK 3R-sTrategies and Harm-benefIt analysis

Research Project | 6 Project Members

Background: The law requires scientists to argue that the 3Rs (replacement, reduction, refinement) have been maximized, i.e. that the same benefits could not have been achieved with lower impact on animal welfare. Guidelines developed by the Swiss Academies of Arts and Sciences explain how scientists need to fill in the required forms and to carry out harm-benefit-analysis (HBA). The guidelines refer to the instrumental and goal-related necessity of experiments, the classification of harms, as well as to the "legitimate interests of society" defined by Art. 137 of the Animal Protection Ordinance. Whether a particular experiment is acceptable is typically evaluated on a case-by-case basis and needs to be approved by a cantonal animal ethics committee (AEC). The Swiss guidelines don't provide specific orientation (e.g. concrete case examples) which types of balancing of interests or cut-off points are considered acceptable. International studies show considerable inconsistency as to how AECs and their individual members evaluate animal protocols. As long as inconsistencies remain poorly understood and opaque, they can be a source of decreased confidence of society in the decision-making process. Studies have shown that limited openness surrounding animal research undermines public trust. Transparency, on the contrary, improves public perceptions. A broader discussion of cases will bring transparency to the context of public debate and advance ethically sound, consistent decision-making. Objectives and methods: 1. Identify strategies designed to improve consistency of research project evaluations and assess critically how they integrate the 3Rs with HBA: Carry out a literature review and ethical analysis on decision-making aids that have been proposed (I) to evaluate and integrate multiple-stakeholder views in decision-making and (II) to promote systematic, accountable practice for HBA by AECs. As these aids - discourse or metric models - have been predominantly developed in the EU or North America, we will examine to which extent they are useful and appropriate in the Swiss legal and administrative context. 2. Obtain novel Swiss comparative qualitative and quantitative data on how and why the public (using clickworkers, n=1000) and relevant stakeholders (see 2a.) make decisions concerning ethical acceptability of a selection of realistic and concrete animal experiments by putting them in the hypothetical role of AEC members that decide on acceptance or rejection of these experiments and making them explain the reasons for their decisions. The cases will be first evaluated by an expert "gold standard" (ethicists and scientists). 2a. Understand factors that influence decision making (role and understanding of the 3Rs, weighing of interests, emotional or other psychological factors, influence of decision-aids identified in 1.) and test decision tipping points by using a convergent parallel mixed methods design (questionnaires, focus groups, participatory multiple-criteria decision analysis [MCDA]). We will compare decision making of the public with that of groups that are likely to benefit (patients, n=200), and actors involved in animal research and its ethical approval (100 junior and 100 senior scientists, 50 AEC members and cantonal administrators); 800 students (psychology, biology, pharmaceutical sciences) from 4 universities (Basel, Lausanne, Fribourg, EPFL) are included to test the influence of teaching interventions. 2b. Use these insights into the decision-making process to identify barriers to appropriate 3R and HBA understanding and implementation in different stakeholder groups. 2c. Develop innovative methods of teaching (e.g. mock AEC settings involving students as AEC members integrating different decision-aids resulting from step 1., see above) and test the influence of teaching on decision making. 3. Combine results from 1. and 2. to foster participatory decision making. The aim is to promote increased knowledge and transparent dialogue in different stakeholder groups in Swiss society about consistent ways to implement the 3Rs and weighing of interests, based on empirical findings and related to concrete cases. Assemble a collection of case examples (made available online) where arguments of the gold standard are explained and compared to findings from the empirical surveys. Importance and benefits: This interdisciplinary project fills a highly important theoretical and practical research gap concerning decision making about which animal experiments are ethically acceptable. It is of high value for several national and international academic debates, as well as of direct practical value for Swiss stakeholders as it advances not only understanding of the 3Rs and HBA, but also their implementation. By putting participants in the role of hypothetical AEC members the empirical part functions as participatory educational intervention that increases transparency and ethical reflection in Switzerland.