SATORI A reasoned proposal for shared approaches to ethics assessment in the European context

This report presents a comprehensive proposal for a common ethics assessment framework for research and innovation (R&I) in the European Union member states. It details recommendations for good practices for ethics assessment, which includes the development of ethics assessment units and the protocols of these units. More specifically, the report presents a general toolkit for ethics assessment of R&I, as well as specialised tools and toolkits for specific types of organizations that deal with ethics assessment, and for different scientific fields. In addition, the report offers recommendations for the general institutional structure of ethics assessment in the EU and its member states. Due to the length of this report, a summary of its findings and recommendations is available. There are also several annexes that expand on particular sections of the report. These a nnexes are also available on the website of the SATORI project. In chapter 2, we analyse the stakeholders’ expectations about the intended outcome of the SATORI project: a shared European framework for ethics assessment of R&I. This analysis is based on 153 interviews with different kind s of stakeholders, including both et hics assessors and non - assessors. Both benefits and obstacles were identified and are listed in this chapter. Furthermore, three main challenges are identified: the differences in ethics/values, the need for stakeholder buy - in, and the need for the ethics assessment framework to be a long - term process. Nonetheless, it is found that a significant majority of interviewees were positive or conditionally positive towards the desirability of a common approach to ethics assessment in R&I. In chapter 3, we propose a framework of ethical issues and principles, which are applicable to a broad array of types of scientific R&I. The research areas discussed in depth are the natural sciences, the engineering sciences, and the medical and life sciences, information and communication technology (ICT), Internet research, the social sciences, and the humanities. It provides a basis of ethical issues and principles that apply to all types of research. It also specifies the principles and issues that apply to specific research contexts. This chapter also includes a section on how potential conflicts between ethical principles may be resolved. In chapter 4, we outline recommendations for best practice in Ethics Assessment Units (EAUs). These recommendations are structured around a series of parameters common to all EAUs that review R&I activity. These parameters include the appropriate composition of an EAU, the appointment, training, and expertise of its members, the procedures for performing assessment, and how to assess the quality and efficiency of the EAU’s work. The cultural and organisational factors that may affect the work of an EAU are also briefly considered. The chapter concludes with a summary of the recommendations presented within it. In chapter 5, we offer a short overview of the Common Framework for Ethical Impact Assessment (EIA) that is described further in Annex 1. This chapter can be used by governance bodies to set up new regulations with regard to ethics assessment in R&I , research funding organisations to set up new procedures for conducting EIAs in the projects they fund , and by local research organisations and companies for establishing internal procedures for conducting an EIA of the R&I projects they organise. In section 6, we present recommendations for specialised forms of ethics assessment and guidance. Specifically, we outline standards, tools and best practices for (1) policy - oriented assessment and guidance of new developments and practices in R&I (with a focus on governmental organisations, national ethics committees, and civil society organisations); (2) guiding, assessing and supporting ethical professional behaviour by scientists and innovators; an d (3) the ethics assessment of innovation and technology development plans. In chapter 7, we discuss ethics assessment (EA) and ethics guidance (EG) in the context of four specific types of organisation: universities, civil society organisations, industry and research funding organisations. In chapter 8, we outline proposals for the institutional structure of ethics assessment in eight types of organisations that perform ethics assessment in the EU member states: universities, national science academies, RFOs, RECs, NECs, academic and professional organisations, CSOs, and companies. In addition, we present recommendations for the institutionalisation of ethics assessment in selected European countries. I n chapter 9, we assess the compatibility of existing ethics assessment frameworks with the SATORI framework. This covers international regulations and guidelines as well as the approaches to ethics assessment in the United States and China. Finally, in chapter 10, we present a summary of the recommendations contained in this report, and conclude in chapter 11 with a list of the annexes to this report. May 19, 2017 (revised version), (Original report completed December 7, 2016), Deliverable D4.1