Section 1: Introduction

This is a summary of a larger report (Deliverable 4.1) that presents the outline of an ethics assessment framework for research and innovation (R&I) in the European Union member states1. It roughly follows the organisation of the larger report.

In section 2, we analyse stakeholders’ expectations about the intended goal of the SATORI project: an European framework for ethics assessment of R&I. This analysis is based on 153 interviews with different kinds of stakeholders, both ethics assessors and non-assessors. The benefits and obstacles are identified and listed in this section.

In section 3, we propose a framework of ethical issues and principles, many forms of scientific R&I. It describes a set 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.

In section 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.

In section 5, we offer a short overview of the Framework for Ethical Impact Assessment (EIA). This section can be used by governance bodies to establish new regulations with regard to ethics assessment in R&I; by research funding organisations to set up new procedures for conducting EIAs in the projects they fund; and by local research organisations and companies for setting up internal procedures for conducting an EIA in 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; and (3) the ethics assessment of innovation and technology development plans.

In section 7, we present recommendations for ethics assessment (EA), and ethics guidance (EG) by specific types of organisations: universities, civil society organisations, industry and research funding organisations.

In section 8, we outline how to conceptualize and implement cost-effectiveness and risk-benefit evaluation of ethics assessment and ethics guidance in relation to European R&I.

In section 9, we summarize the SATORI work on standardisation of ethics assessment of R&I, where the objective was to assess the feasibility of developing a standard for ethics assessment of research and innovation (R&I) and develop such a standard.

In section 10, we outline our work on policy initiatives and policy developments at the global, European, and national levels related to ethics assessment of research and innovation (R&I), covering the period 2014-2017.

In section 11, we outline proposals for the institutional structure of ethics assessment in the European Union and its constituent countries. They address the institutional setup of eight different types of ethics assessors at the European Union level.

In section 12, 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 section 13, we sketch a strategy to ensure the sustainability of the work carried out in the SATORI project and to give future actors the means to efficiently implement the recommendations.

  1. Philip Jansen, Wessel Reijers, David Douglas, Agata Gurzawska, Alexandra Kapeller, Philip Brey, Rok Benčin, Zuzanna Warso, SATORI Deliverable D4.1 A Reasoned Proposal for Shared Approaches for Ethics Assessment in the European Context, December 2016. Philip Jansen, Wessel Reijers, David Douglas, Agata Gurzawska, Alexandra Kapeller, Philip Brey, Rok Benčin, Zuzanna Warso, SATORI Deliverable D4.1 A Reasoned Proposal for Shared Approaches for Ethics Assessment in the European Context, December 2016. Link to PDF