Work Package 1:
Comparative analysis of ethics assessment practices
-
Deliverable 1.1: Ethical assessment of R&I: a comparative analysis
Task Leader: TRI
-
Main Report: Ethical assessment of R&I: a comparative analysis
This deliverable offers a detailed picture of the de facto ethics assessment landscape in the European Union and other countries with regard to approaches, practices and institutions for ethics assessment across scientific fields, different kinds of organisations that carry out assessment, and different countries. The deliverable is based on in-depth study of ethics assessment in ten countries in the European Union, and the United States (US) and China, as well as studies of particular organisations in other EU countries. This main report summarises the results of work package 1 of the SATORI project and provides a comparative analysis of ethics assessment in the scientific fields, organisations and countries investigated.
The annex to the report consists of detailed studies of ethics assessment in different scientific fields, types of organisations and countries, in addition to a number of reports on major principles, issues and approaches in ethics assessment.
-
Annex 1: Principles and Approaches in Ethics Assessment
-
1.a Ethical Impact Assessment and Conventional Impact Assessment
This report aims to make a conceptual comparison of assessment approaches of research and innovation that focus on impacts, with special attention to ethical approaches. The report discusses two ethical approaches that focus on impacts, Ethical Technology Assessment and Ethical Impact Assessment. These approaches will be compared and contrasted with approaches in the broader fields of technology assessment (TA) and impact assessment (IA), including environmental impact assessment (EIA) and social impact assessment (SIA). Having a better understanding of the place of the new concepts within the family of previously developed assessment forms will help to contextualize the concepts within the existing field of procedural innovations around science, technology and innovation (STI) policy.
-
Scientific research is a conscious and systematic approach to acquire knowledge, based on theories, methods and standards that have been developed through the history of scientific disciplines. The terms “research integrity” and “good research practice” refer to ideals for how research ought to be performed.
-
The aim of this report is to analyse social responsibility as a principle in ethics assessment and ethical guidance of research and innovation (R&I). This section will introduce the principle, both in its use in relation to individual scientists and engineers, and its use in the notion of corporate social responsibility (CSR) in industry. The next section will discuss different understandings and applications of this principle in the major divisions of science, namely the medical and life sciences, social sciences, humanities, natural sciences and engineering. The third section will discuss the notion of corporate social responsibility in more detail. The fourth section will list important organisations, conference series and publication series that are concerned with social responsibility in science and engineering, while the fifth section will discuss national and international legislation, regulation and frameworks related to the principle. The sixth and final section contains literature references for the principle.
-
This report on human subjects research provides an overview of the use of humans in research in different scientific fields, examines central values and principles central for the area, in addition to providing a discussion of some key ethical issues. Section 2 provides a basic description of human subject research, including a short historical overview. Section 3 provides a brief description of regulatory frameworks in the area. Section 4 offers a discussion on human participation in social science and the humanities. Section 5 introduces and discusses ethical principles and values prevalent in human subjects research and introduces some key ethical issues.
-
A starting point for the discussion about institutional integrity is the concept of integrity and distinguishing between personal integrity and institutional integrity. Integrity refers to principled behaviour. Dictionaries define integrity as the firm adherence to a code of moral values and principles, incorruptibility and soundness, uprightness and honesty, and consistency between one’s actions and one’s principles, methods and measures.
-
1.f The use of animals in research
This report discusses the use of animals in research. It provides a basic description on the use of animals in research, examines EU legislation for the protection of animals used for scientific purposes, the values and principles prevalent in the area, and key ethical issues. It also looks at the key organisations, institutionalisation, international frameworks and protocols and other relevant issues.
-
This report aims to study and discuss the ethical aspects of risk assessment and management, and how risk plays a role in the ethical assessment of research. It introduces the central concepts – risk and ethics – and examines the different phases of the risk management process from the ethical point of view. It also describes the ethical principles used to determine whether the risks of conducting research are acceptable. The increasing complexity of systems, products and services due to new technological and social developments is making risk assessment and management more challenging and emphasizes the need to consider ethical issues systematically in the risk assessment process.
-
-
Annex 2: Ethics Assessment in Different Fields
-
This report tackles ethical values and issues and their institutionalisation in the natural sciences. The focus here is on chemistry and physics, with some mention of the earth sciences. Biology, medical sciences and emerging technologies are excluded as they are the subject of other SATORI reports. This also entails that human subjects research issues are given less attention here. More consideration is therefore given to issues concerning scientific integrity and societal responsibility.
-
This is a report on ethics assessment of research and innovation in engineering. In a broad sense, ethics assessment of engineering refers to any kind of assessment, evaluation, review, appraisal or valuation of research or innovation within engineering that makes use of ethical principles or criteria. The report will cover both the academic traditions of ethics assessment in engineering and the institutionalisation of it in different types of organisations, including
national and international standards and legislation. It is part of a larger study of the SATORI project that focuses on ethics assessment of research and innovation in five scientific fields: the humanities, the medical sciences, the social sciences, the natural sciences, and engineering.-
Information technology (IT) is the application of computers and telecommunications equipment to store, retrieve, transmit and manipulate data. The term is commonly used as a synonym for computers and computer networks, but it also encompasses other information distribution technologies, such as smartphones, robotics and Artificial Intelligence (AI). Furthermore, IT is often used to designate practices that are made possible by computers and telecommunications, such as social media, e-commerce and computer games. Several industries are associated with information technology, broadly categorisable as computer hardware, software, electronics, semiconductors, internet, telecom equipment, e-commerce and computer services.
-
-
This is a report on ethics assessment of medical and life sciences. Ethics assessment concerns the question what is good and bad or right and wrong about a certain technology or practice. Such assessments help organisations determine to what extent ethical standards should influence decision making at both organisational and individual levels. The aim of this report is to cover both the academic and non-academic traditions of ethical assessment, and the institutionalisation of ethics assessment in different types of organisations, including national and international standards and legislation. This report is a part of a larger study of the SATORI project.
-
2.c.1 Neurosciences and Neurotechnologies
This contribution first offers a basic description of neurosciences. The chapter is divided into the description of neuroimaging, novel neurotechnologies, and neuroenhancement. The following chapter analyses the ethics issue debate in international medical journals, medical ethics journals, ethics journals, and in reports of National Bioethics Commissions who have worked on the issues grouped according to the three fields identified in the previous chapter. Finally the study offers a list of organisations which are leading the ethics debate in the field as well as a short description of the related institutional setting for reviewing research in the field of neurosciences, and a short description of the international legal framework governing therapeutic interventions in the neurosciences. A list of relevant journals and key publications rounds up the report.
-
The possibility of repairing or replacing tissue or organ function lost due to age, disease, damage or congenital defects, using human stem cells (hSCs), raises deep ethical issues, often evoking strong emotions. Even with increased support for research projects in transplantation, there remains an enormous need for Regenerative Medicine (RM) therapies. In the last decade, research in these areas has been translated into early clinical trials with mixed results, raising hope amongst patients. There are many different sources of hSCs, each having their own advantages and disadvantages. The various types of hSCs are based upon a taxonomy devised by Professor Austin Smith, as published in Nature in 2006. One significant factor that has influenced the course of hSCs research is the ethics surrounding their use.
-
Agriculture – basic description and features
The production, transformation and distribution of food and other agricultural products, generally accepted as routine aspects of daily life around the world, have a long history - the domestication of plants and animals began already 12,000 years ago in different parts of the world. Since that time, in most parts, agricultural practices have undergone significant changes from simple cultivation of crops and rearing of livestock. Agriculture has become intertwined with technological advances.
-
-
This report on ethical assessment of research and innovation in social sciences is a part of a comparative study across scientific fields and disciplines within a wider analysis of EU and international practices of ethical assessment, made by the SATORI project. Ethical assessment in this analysis covers any kind of review or evaluation of research and innovation based on ethical principles. The report will focus on academic traditions of ethics assessment in the field, various types of (national and international) organisations involved in assessment and relevant legislation.
-
2.d.2 Internet Research Ethics
The development of the Internet and other communications technologies have seen a parallel growth in the development and use of technologically -
based research methodologies. In particular, the Internet has emerged as a major data resource for research across disciplines, ranging from the social sciences to arts and humanities, medical and biomedical sciences and the natural sciences.
-
This report on ethical assessment of research and innovation in humanities is a part of a comparative study across scientific fields and disciplines within a wider analysis of EU and international practices of ethical assessment, conducted by the SATORI project. Ethical assessment in this analysis covers any kind of review or evaluation of research and innovation based on ethical principles. The report will focus on academic traditions of ethics assessment in the field, various types of (national and international) organisations involved in assessment and relevant legislation.
-
-
Annex 3: Ethics Assessment in Different Types of Organizations
-
3.a Research Ethics Committees
The aim of this report is to analyse and compare how ethics assessment of research and innovation is performed by Research Ethics Committees (RECs) in the European Union, Norway, Serbia, the United States and China. This report is based on online and offline documentation, previously published reports, and interviews with representatives of organisations in eleven countries. Nine representative European countries were selected for in-depth study, including seven EU members and one candidate for EU membership, and one non-EU (non-candidate) member: Austria, France, Germany, the Netherlands, Norway (non-EU member), Poland, Serbia (an EU candidate country), Spain and the United Kingdom. The main source for the in-depth study is interviews. Based on these interviews, we have compiled tables for all interviewed organizations, that are included as an annex to this report.
-
3.b National Ethics Committees
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation is performed by National Ethics Committees (NECs) in the European Union (EU) and the United States (US). The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in 13 different Committees in the EU and at international and regional level. In the report, it will be investigated how these NECs are organised. It will be studied how NECs are institutionally embedded, how they perform ethics guidance and with what aims, and what the perceived strengths and weaknesses of their work are.
-
3.c Research Funding Organisations
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation is performed by funding organisations in Europe, China, and the United States (US). The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in nine different countries (seven European countries, China, and the US) and Institutions of the European Union (EU). Seven representative European countries have been singled out for in-depth study, including six EU member states (Austria, Germany, the Netherlands, Poland, Spain, United Kingdom) and one candidate for EU membership (Serbia). In the report, it will be studied how Research Funding Organisations are institutionally embedded, how they perform ethics assessment and with what aims, and what the perceived strengths and weaknesses are
-
3.d National Science Academies and Academic & Professional Organisations
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation is performed by national science academies and academic and professional organisations in the European Union, the United States and China. The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in ten different countries and at the EU and global international level. Eight representative European countries were singled out for in-depth study, including seven EU members and one candidate for EU membership: Austria, France, Germany, the Netherlands, Poland, Serbia (EU candidate country), Spain and the United Kingdom. This report investigates how national science academies and academic and professional organisations are organised in these countries, in China, the US and, if applicable, at the EU and global international level. It considers the situation in other EU member states and candidate and studies how organisations of this type are institutionally embedded, how they perform ethics assessment and guidance and with what aims, and what are the perceived strengths and weaknesses of their participation in ethics assessment and guidance.
-
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation is performed by universities in the European Union, the United States and China. The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in ten different countries and at the EU and global international level. Eight representative European countries have been singled out for in-depth study, including seven EU members and one candidate for EU membership: Austria, France, Germany, the Netherlands, Poland, Serbia (EU candidate country), Spain and the United Kingdom. In the report, it will be investigated how universities are organised in these countries, in China, the US and at the EU and global international level. The situation in other EU member states and candidate countries will be considered as well. It will be studied how organisations of this type are institutionally embedded, how they perform ethics assessment and guidance and with what aims, and what are the perceived strengths and weaknesses of their participation in ethics assessment and guidance.
-
3.f Government and Government-Funded Organisations
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation is performed by Government and Government-Funded Organisationsin the European Union, the United States and China.The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in ten different countries and at the EU and global international level. Eight representative European countries were singled out for in-depth study, including seven EU members and one candidate for EU membership: Austria, France, Germany, the Netherlands, Poland, Serbia (EU candidate country), Spain and the United Kingdom. An Italian organisation has been included as well, see Table 1. This report investigates how Government and Government-Funded Organisations are organised in these countries, China, the US and, if applicable, at the EU and global international level. The report also considers the situation in other EU memberstates and candidate countries. It studies how organisations of this type are institutionally embedded, how they perform ethics assessment and guidance and with what aims, and what are the perceived strengths and weaknesses of their participation in ethics assessment and guidance.
-
3.g Civil society organisations
The aim of this report is to analyse and compare the way in which ethics assessment and ethical guidance of research and innovation is performed by Civil Society Organisations in the European Union, the United States and China. The report is based on online and offline documentation, previous published reports, and interviews with representatives of organisations in ten different countries and at the EU and global international level. Eight representative European countries have been singled out for in-depth study, including seven EU members and one candidate for EU membership: Austria, France, Germany, the Netherlands, Poland, Serbia (EU candidate country), Spain and the United Kingdom. The report describes how Civil Society Organisations are organised in these countries, in China, the US and, where relevant, at the EU and global levels. The situation in other EU member states and candidate countries will be considered as well. The report offers insights into the ways in which organisations of this type are institutionally embedded, how they perform ethics assessment and guidance and with what aims, and what are the perceived strengths and weaknesses of their participation in ethics assessment and guidance.
-
3.i Standards, certification and accreditation organisations
This report looks at some organisations that focus on developing standards, certification and/or accreditation of ethical research, R&D organisations and professionals, involved in research and innovation. The scope of this report is limited, it does not scope out the entirety of the standards, certification and accreditation landscape, rather, it provides a brief overview of the standards, certification and accreditation organisations (some of which represent established formalised bodies, and others that are relevant but less formalised). The report is based on desktop research and draws insights from discussions with the Netherlands Standardization Institute.
-
The aim of this report is to analyse and compare how ethics assessment and ethical guidance of research and innovation, with a particular focus on Corporate Social Responsibility (CSR) strategies, is performed by industry in the European Union, the United States and China. The study analyses practices of multi- and transnational corporation (MNCs and TNCs), small and medium sized enterprises (SMEs), chambers of commerce, consultancy firms, research institutes and NGOs engaged in the topic of human rights and business. Furthermore, various sectors of industry are taken into consideration.
-
-
Annex 4: Ethics Assessment in Different Countries
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in Austria, both for the public and private sector. It analyses how the national government has put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs). Ethics assessment, as used in this report, not only refers to the field of biomedical research and innovation, in which the term “ethics assessment” is traditionally used, but also to other fields in which the balancing of risks and benefits is of importance.
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in China, both for the public and the private sector. The report will analyse how the national government has put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
This report gives an overview of ethics assessment procedures, principles and values as well as the organisational structures of four non research ethics committees. The reports shows how all four organisations operate on a non-binding basis, and are either embedded in the Danish ministries, acts as advisory councils or function as temporary issue-based organisations in university settings.
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation (R&I) in France, both for the public and private sectors. It will analyse how the national and regional government have developed organisational structures, laws, policies and procedures for ethical assessment; how both publicly funded and private research and innovation systems address ethical issues in research and innovation; and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in Germany, both for the public and private sector. We will analyse how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in the Netherlands, both for the public and the private sector. It will be analysed how the national government has put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation (R&I) systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in Poland, both for the public and private sector. It will be analysed how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in the Republic of Serbia, both for the public and private sector. It will analyse how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in Spain, both for the public and private sector. It will be analysed how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs).
-
This report offers an analysis of the existing structures and agents for the ethical assessment of research and innovation in the UK, both for the public and the private sector. It sets out how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical
assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs). -
The aim of this report is to analyse the existing structures and agents for the ethical assessment of research and innovation in the United States of America (U.S.), both for the public and private sector. It will analyse how national and regional governments have put into place organisational structures, laws, policies and procedures for ethical assessment, how both publicly funded and private research and innovation systems address ethical issues in research and innovation, and how ethical assessment plays a role in the activities of professional groups and associations for research and innovation and of civil society organisations (CSOs). We will begin by providing some basic information about the U.S. and the historical development of ethics assessment institutions in the country.
-
-
Annex 5: Ethics Assessment at the EU and Global Level
-
5.a Ethics Assessment and Guidance at the European Union Level
The aim of this report is to provide an analysis of the existing structures and agents for the ethical assessment of research and innovation in the European Union (EU), both for the public and private sectors. The report focuses on EU-level structures only and not those at the national level. The report describes how organisational structures, laws, policies and procedures for ethical assessment have been put in place at the EU level; the ways in which publicly funded and private research and innovation systems address ethical issues in research and innovation; and the role of ethical assessment in the activities of professional groups and associations for research and innovation. The report has been compiled using data gathered from public sources such as organisational websites, books, and articles, in addition to interviews carried out with representatives of some organisations mentioned here. The discussion section draws on insights from some of the SATORI stakeholder interviews.
-
5.b EA and Guidance at the Global level
The aim of this report is to analyse the excisting structures and agents for the ethical assessment and guidance of research and innovation at the global international level. This chapter offers an analysis of the ways in which organisational structures, laws, policies and procedures for ethical assessment and guidance have been put in place at the global level; the ways in which both publicly funded and private research and innovation systems address ethcial issues in research and innovation; and the role of ethical assessment in the activities of professional groups and associations for research and innovation.
-
-
Main Report: Ethical assessment of R&I: a comparative analysis