This report presents the condensed results of our efforts to create an ethics assessment framework for European Union member states. At the core of our efforts has been the development of proposals for good practices for ethics assessment, including the development of ethics assessment units and the protocols of these units. We have developed a general toolkit for such assessment, as well as specialised tools and toolkits for specific types of organisations and scientific fields. In addition, we have developed recommendations for the general institutional structure of ethics assessment in the EU and its member states.
Ethics Assessment Organisations’ Expectations about a Joint Framework
In the report, we first presented the results of our analysis of stakeholders’ expectations about an European framework for ethics assessment of research and innovation. The analysis was based on 153 interviews with different kinds of stakeholders, both ethics assessors and non-assessors, who were asked to share their opinions on the desirability and possibility of such a framework. Of all interview respondents, 51.6 percent thought it would be desirable to have a shared European framework, and 30 percent were conditionally positive on the desirability of the framework. Many interviewees cited as potential benefits the unification, harmonisation and convergence of EA principles and procedures. They also highlighted two major challenges for the development of a common framework. The first is to achieve harmonisation of ethical principles and procedures, while at the same time allowing for differences between countries and scientific fields. The second is for the framework to function at a general level to account for differences between countries, cultures, ethical values, philosophies, and scientific fields, while at the same time providing useful tools for solving concrete ethical dilemmas.
Ethical Principles and Issues
We subsequently proposed a framework of ethical issues and principles that is applicable to a broad range of R&I activities. This framework firstly lists key ethical issues and principles that apply to all types of research, following three dimensions: professional conduct, research practice and societal impacts. Examples of shared ethical issues and principles are accountability, respect for colleagues, stewardship, scientific freedom, scientific integrity, openness, beneficence, and social responsibility. Secondly, our framework specifies the principles and issues that apply to specific research contexts: research aimed at technological innovations, research involving human subjects, personal data, animals, environmental risks or significant aspects of human society and culture. The issues and principles in these categories include: reduction of dual use harms, precaution, fairness, respect for human research subjects, respect for privacy, avoidance of bias, protection of vulnerable people, respectful treatment of animals in experiments, care for animal research subjects, avoidance of harm towards animals, safety, social responsibility, sustainability, responsible conduct of research, freedom and independence of research, scientific integrity, respect for biodiversity and cultural diversity, protection of communities, and responsible treatment of cultural heritage.
Ethics Assessment Procedures
Next, we outlined recommendations for best practices in Ethics Assessment Units. These recommendations are structured around a series of parameters common to all EAUs that review R&I activity: composition and expertise; appointment and training; procedures prior to assessment; procedures during assessment; procedures after assessment; supervision; quality assurance; efficiency considerations; organisational and cultural factors. For example, we recommended that the membership of an EAU be arranged so that it encourages rigorous discussion and evaluation of R&I activity – which could best be achieved by including members who are competent (technically, ethically, and administratively), independent of the researchers and the institutions involved, diverse in backgrounds and expertise, and representative of the communities affected by their decisions. Another recommendation holds that the assessment procedure be designed to ensure that the conducted R&I activity (1) protects stakeholders from undue risk and harm, (2) ensures that participation in research, trials and similar activities related to the R&I activity is voluntary, (3) determines if the research or innovation methods are appropriate, and (4) aims to increase the awareness of the ethical impact of R&I. Finally, to highlight one last recommendation, we have proposed that EAUs consider using a modified version of the Plan-Do-Check-Act (PDCA) process for quality assurance of ethics assessment.
Ethical Impact Assessment
We then presented an overview of SATORI’s Framework for Ethical Impact Assessment. This framework can be used by governance bodies to establish new regulations in relation to ethical impact assessment in R&I; by research funding organisations to establish procedures for conducting EIAs in the projects they fund; and by local research organisations and companies in order to establish internal procedures for conducting an EIA in their R&I projects. Our framework presents the EIA process as a series of five stages: the EIA threshold analysis stage, the ethical impact anticipation and determination stage, the ethical impact evaluation stage, the remedial actions stage, and the review and audit stage. The threshold analysis stage of an EIA determines the kind of EIA procedure that could be implemented in an R&I project (small-scale, mid-range, or full-scale EIA). In the EI anticipation and determination stage, the persons involved in the EIA try to map the ethical impacts that might occur in the context of the R&I project and put them on a timeline (short-term, medium-term, and long-term impacts). The EI evaluation stage assesses the relative severity of the potential impacts, the likelihood of their occurrence, and any potential value conflicts that may arise. In the remedial actions stage, remedial actions may be designed and performed in response to the negative impacts found and analysed during EI anticipation & determination and EI evaluation stages. The review and audit stage of an EIA, finally, is aimed at ensuring independent evaluation of the EIA process and, if necessary, independent corrective intervention in it.
Specialised Forms of Ethical Assessment and Guidance
Next, we presented recommendations for specialised forms of ethics assessment and guidance. Specifically, we outlined standards, tools and best practices for (1) policy-oriented assessment and guidance of new developments and practices in R&I; (2) guiding, assessing and supporting ethical professional behaviour by scientists and innovators; and (3) the ethics assessment of innovation and technology development plans. With regard to policy-oriented assessment and guidance, we recommended, for example, that governmental organisations directly involve CSOs and non-ethicists or lay persons in the ethics assessment and guidance processes, and that they take into account the value of democracy in the composition of ethics guidance and assessment bodies. In relation to guiding, assessing and supporting ethical professional behaviour by scientists and innovators, we recommended, for example, that researchers abide by ethical standards that include principles such as objectivity and impartiality, truthfulness and transparency, honesty and openness, respect and fairness, conformity to regulation, guidelines and good practices, integrity in international cooperation, and social responsibility. Finally, with regard to ethics assessment of innovation and technology development plans, we proposed, among other things, increased stakeholder participation in the EIA process for building projects in urban areas (given their large potential impacts on communities), and an EIA that is more principle-driven for (consumer) product development.
Ethics Assessment and Ethics Guidance by Specific Types of Organisations
We subsequently discussed ethics assessment and guidance in the context of four specific types of organisations: universities, CSOs, industry and RFOs. We recommended that universities develop generalised codes of ethics (not focused on any specific discipline) which explicitly address researcher conduct in R&I, that these codes be implemented in their curricula and institutional strategies, and that research integrity boards investigate alleged breaches of the codes of ethics in an independent, fair and credible way. For CSOs, we recommended increased involvement in RECs as representatives for specific vulnerable groups or interests, and the creation of ethics-assessment-related CSO networks for the exchange of best practices. For industry, we outlined as number of good practices, which include defining responsibility for ethics assessment along all levels of the organisation, setting a company-wide strategy for ethics assessment based on a structured, step-by-step procedure (e.g., the Plan, Do, Check, Act cycle), and ensuring transparency and responsibility in the ethics assessment process. Finally, we recommended that RFOs establish procedures for in-house ethics assessment going beyond what is required by law, and focus their evaluations on issues and principles specific to the field of research to which the proposal under consideration belongs, among other things.
Proposals for the Institutional Structure of Ethics Assessment in the European Union and its Constituent Countries
We then outlined proposals for the institutional structure of ethics assessment in eight types of ethics-assessment-performing organisations in the EU member states: universities, national science academies, RFOs, RECs, NECs, academic and professional organisations, CSOs, and companies. In addition, we presented recommendations for the institutionalisation of ethics assessment for selected European countries. We recommended, for example, that university associations and national academies of sciences should, with the help of professional organisations, establish and commit to a joint framework that would set general standards at a national level regarding RECs in the higher education system. In addition, we recommended that NECs broaden their focus to encompass all other scientific fields besides the medical and life sciences, thus instituting special sub-committees for different disciplines. We further recommended that academic and professional organisations create forums for the consolidation of developments in ethics assessment. Lastly, with regard to national institutional structures, we recommended, for example, that in countries without a NEC, governments establish a NEC to coordinate RECs, develop EA and guidance procedures, and provide a platform for discussion and cooperation on ethics assessment.
Assessing the Compatibility of Existing Ethics Assessment Frameworks with the SATORI Framework
Finally, we argued for the compatibility of existing ethics assessment frameworks with the SATORI framework. Our framework does not seem to have any clear areas of conflict with international regulations or guidelines. General human rights guidelines helped guide the inauguration of formal ethics assessment, and SATORI draws heavily on the notion of human rights issues and principles as a basis for ethics assessment and guidance. Therefore, there is an obvious synergy between them. And even though international regulations may operate in different fields, the procedures they offer for their own implementation affirm the type of approach that SATORI suggests. As with SATORI, the regulations advocate for policy discussions to include all relevant stakeholders, including local actors, private industry, NGOs and diverse community members (racially and by gender). Even so, national priorities may produce priority conflicts with the SATORI approach, such as the drive to grow economies in line with historical precedents for industrialization that may not account for current ethical considerations. Where this issue arises, the ethical deliberation principles advocated by the SATORI framework can be applied to provide a conduit for addressing the underlying issues and principles.