Doris Schroeder

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any research stakeholder who opposes double standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding

Achieving equity in international research is one of the pressing concerns of the twenty-first century. In this era of progressive globalization, there are many opportunities for the deliberate or accidental export of unethical research practices from high-income regions to low- and middle-income countries and emerging economies. The export of unethical practices, termed “ethics dumping,” may occur through all forms of research and can affect individuals, communities, countries, animals, and the environment. Ethics dumping may be the result of purposeful exploitation but often arises from lack of awareness of good ethical and governance practice. This chapter describes the work of the TRUST project toward counteracting the practice of ethics dumping through the development of tools for the improvement of research governance structures. Multi-stakeholder consultation informs all of TRUST’s developments. Most importantly, this gives voice to marginalized vulnerable groups and indigenous people, who have been equal and active partners throughout the project. At the heart of the TRUST project is an ambitious aim to develop a Global Code of Conduct for Research in Resource-Poor Settings. Uniquely, the Code provides guidance across all research disciplines in clear, short statements, focusing on research collaborations that entail considerable imbalances of power, resources and knowledge and using a new framework based on the values of fairness, respect, care, and honesty. The code was recently adopted by the European Commission as a reference document for Horizon 2020 and Horizon Europe.

Global bioethics is a bold project. In its moderate form, it aims to find solutions to the dilemmas posed by modern medicine and the biological sciences through intercultural understanding of human obligations and opportunities. In its more ambitious form, it endeavors to cover all possible ethical problems arising with regard to life and living things on earth. Given the ambitiousness of even the moderate aim, it is unsurprising that disputes are frequent and agreements are scarce. One of the most contentious issues is whether human rights should play an important role in global bioethics or not. a

This open access collection of AI ethics case studies is the first book to present real-life case studies combined with commentaries and strategies for overcoming ethical challenges. Case studies are one of the best ways to learn about ethical dilemmas and to achieve insights into various complexities and stakeholder perspectives. Given the omnipresence of AI ethics in academic, policy and media debates, the book will be suitable for a wide range of audiences, from scholars of different disciplines (e.g. AI science, ethics, politics, philosophy, economics) to policy-makers, lobbying NGOs, teachers and the educated public.

The European debate around genetically modified foods was one of the most sustained and ardent public discussions in the late 1990s. Concerns about risks to human health and the environment were voiced alongside claims that healthier foods can be produced more efficiently and in a more environmentally friendly manner using the new technology. The aims of this paper are to test the usefulness of Stephen Toulmin’s argumentation model for the analysis of public debates almost 50 years after it was first introduced, and to establish whether any of the parties in the genetically modified food debate used seriously flawed argumentation. The paper argues that Stephen Toulmin’s argumentation model can be useful in three ways when analysing public debates. Firstly, incomplete or flawed claims can be defeated by exposing missing or mismatching argumentation elements; all examined arguments in the GM debate were well formulated. Secondly, weaknesses in argumentation can be identified by making explicit warrants and backing; in the GM case, this allowed the identification of points of attack for counter-argumentation. Thirdly, analysing the type of backing used, allows inferences about the persuasion approach taken. The industrialists employed ethical principles as their backing much more than the scientists and environmentalists, a surprising result.

This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.

Responsible Research and Innovation (RRI) has emerged as a science policy framework that attempts to import broad social values into technological innovation processes whilst supporting institutional decision-making under conditions of uncertainty and ambiguity. When looking at RRI from a ‘principled’ perspective, we consider responsibility and justice to be important cornerstones of the framework. The main aim of this article is to suggest a method of realising these principles through the application of a limited Rawlsian Difference Principle in the distribution of public funds for research and innovation. There are reasons why the world's combined innovative capacity has spewed forth iPhones and space shuttles but not yet managed to produce clean energy or universal access to clean water. (Stilgoe 2013, xii) I derive great optimism from empathy's evolutionary antiquity. It makes it a robust trait that will develop in virtually every human being so that society can count on it and try to foster and grow it. It is a human universal. (de Waal 2009, 209) Responsible Research and Innovation (RRI) has emerged as a science policy framework that attempts to import broad social values into technological innovation processes whilst supporting institutional decision-making under conditions of uncertainty and ambiguity. In this respect, RRI re-focuses technological governance from standard debates on risks to discussions about the ethical stewardship of innovation. This is a radical step in Science & Technology (S&T) policy as it lifts the non-quantifiable concept of values into the driving seat of decision-making. The focus of innovation then goes beyond product considerations to include the processes and – importantly – the purposes of innovation (Owen et al. 2013, 34). Shared public values are seen as the cornerstone of the new RRI framework, while market mechanisms and risk-based regulations are of a secondary order. What are the values that could drive RRI? There are different approaches to the identification of public values. They can be located in democratically agreed processes and commitments (such as European Union treaties and policy statements) or they can be developed organically via public engagement processes. Both approaches have advantages and disadvantages. For instance, although constitutional values can be regarded as democratically legitimate, their application to specific technological fields can be difficult or ambiguous (Schroeder and Rerimassie 2015). On the other hand, public engagement can accurately reflect stakeholder values but is not necessarily free from bias and lobbyist agenda setting. We argue that if RRI is to be more successful in resolving policy dilemmas arising from poorly described and uncertain technological impacts, basic universal principles need to be evoked and applied. When looking at RRI from a ‘principled’ perspective, we consider responsibility and justice to be important cornerstones of the framework. One could describe them in the following manner: Research and innovation should be conducted responsibly. Publicly funded research and innovation should be focused fairly on socially beneficial targets. Research and innovation should promote and not hinder social justice. The main aim of this article is to suggest a method of realising these principles through the application of a limited Rawlsian Difference Principle in the distribution of public funds for research and innovation. This paper is in three parts. The first part discusses the above principles and introduces the Rawlsian Difference Principle. The second part identifies how RRI is currently applied by public funding bodies. The third part discusses the operationalisation of the Rawlsian Difference Principle in responsible funding decisions.

Indigenous Peoples, Consent and Benefit Sharing is the first in-depth account of the Hoodia bioprospecting case and use of San traditional knowledge, placing it in the global context of indigenous peoples’ rights, consent and benefit-sharing. It is unique as the first interdisciplinary analysis of consent and benefit sharing in which philosophers apply their minds to questions of justice in the Convention on Biological Diversity (CBD), lawyers interrogate the use of intellectual property rights to protect traditional knowledge, environmental scientists analyse implications for national policies, anthropologists grapple with the commodification of knowledge and, uniquely, case experts from Asia, Australia and North America bring their collective expertise and experiences to bear on the San-Hoodia case. While much of the focus is on bioprospecting and natural product development, Indigenous Peoples, Consent and Benefit-Sharing also draws important lessons about informed consent and benefit-sharing from the health sciences and sectors such as mining. Policymakers around the world are under significant pressure to resolve the challenges of implementing the CBD. This book’s analysis and recommendations will help them. ‘It is good to see philosophers engaging with the UN Convention on Biological Diversity, and doing so by looking in depth at a real situation in which it has been invoked.’ Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University

Ethics dumping is a global phenomenon involving the ‘off-shoring’of research. Research that would be prohibited, severely restrictedor regarded as highly patronizing in high-income regions is instead conducted inresource-poor settings. Twenty-eight case studies of ethics dumping were examined through inductive thematic analysis to reveal predisposing factors from the perspective of researchers from high-income regions. Six categories were agreed and further illuminated: Patronizing conduct, unfair distribution of benefits and/or burdens, culturally inappropriate conduct, double standards, lack of due diligence and lack of transparency. The ultimate aim of the paper is to deepen understanding of thesehighly unethical practicesamongst academics who stand against poverty, leading to theirfurther reduction.

Trust in the "agro-food" sector has been declining in recent years reflecting a general decline of trust in traditional decision making processes. The introduction of new technologies in the production of foods re-introduces the problem of trust and highlights the parameters affecting its structure and direction. This paper discusses the issue of trust in relation to the introduction of functional foods into the market. Trust is assessed as both a philosophical and a psychological construct with particular emphasis on its communication aspects. The paper ends with specific recommendations for action in the agro-food sector

Over the past decade the welfare state has come under sustained attack not only from quarters which never approved of its policies, but also from political theorists who used to support it. With the collapse of communism, the policy of comprehensive welfare provision came under renewed scrutiny. It was argued that its impact on work incentives is most detrimental. Examining in detail current unemployment debates within Western welfare states, this book seeks to verify or refute the view that non-work is increasingly chosen by work shy individuals - the 'pathological' theory of unemployment. Drawing from a range of disciplinary perspectives - from social philosophy and the history of philosophy, to occupational psychology and feminist economics - this interdisciplinary analysis reveals that the "pathological" theory of unemployment, with its reliance on a deficient depiction of human nature and its disregard of non-pecuniary work incentives and empirical evidence on benefit fraud, cannot be upheld.

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries.

ABSTRACT Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as to enable research subjects to claim a share of the benefits to be negotiated on a case‐by‐case basis. Our conclusion on this question is: ‘No, the CBD should not be expanded to include human genetic resources.’ There are essential differences between human and non‐human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as ‘window dressing’. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization’s Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed.

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity

Responsible research and innovation (RRI) is a governance framework promoted by influential policy makers such as the European Commission and academics from the fields of science and technology studies and management. This book is the first text to serve industry. Inspired by existing Corporate Responsibility standards and principles, it offers a selection of tools that can assist practitioners in implementing RRI in business and industry. Responsible Research and Innovation (RRI) is integrative. It is a convergence of Technology Assessment (TA) and Ethics, including corporate responsibility. The task of linking RRI to existing frameworks has only just begun. This book is a welcome example, showing how Corporate Responsibility tools can drive the implementation of RRI. Prof. Armin Grunwald, Head of the Office of Technology Assessment at the German Bundestag and Head of the Institute for Technology Assessment and Systems Analysis, Karlsruhe Institute of Technology, Germany. This is a simple, short, yet encyclopaedic work designed to help business implement RRI using the many tools of Corporate Responsibility (CR) already in place, everything from ISO9001 to the Ceres Roadmap for Sustainability. It makes clear the ways in which RRI is an extension of ideas already well-developed in CR. I learned a lot reading it. Prof. Michael Davis, Senior Fellow, Center for the Study of Ethics in the Professions, Illinois Institute of Technology, USA

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity.

BMJ Editorial Campaigners are calling on policy makers at next week's sixth World Trade Organization ministerial conference in Hong Kong to make trade fairer for and improve the lives and health of the world's poorest people. This broad and important aim may dominate the headlines, but ministers will also be discussing technical issues surrounding international patenting laws. One issue with implications for the development of medical products is the tension between international patenting laws and benefit sharing requirements, which may threaten agreements on protecting biodiversity. If the biodiversity door shuts because of protests in developing countries, pharmaceutical research will be seriously hampered.

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa.

Achieving equity in international research is a pressing concern. Exploitation in any scenario, whether of human research participants, institutions, local communities, animals or the environment, raises the overarching question of how to avoid such exploitation. Agreed principles can be universally applied to research in any discipline or geographical area, whatever methodologies are employed. This chapter introduces a collection of case studies, presenting a range of up-to-date examples of exploitation in North-South research collaborations, in order to raise awareness of ethics dumping.

This collection examines how the field of ethics has developed over the past fifty years, by bringing together those articles that have been seminal in the development of the subject. Each of the six volumes carries an introduction presenting the historical context of the material, and a new index is provided to identify key philosophical themes and trends within the collection. The volumes are organized thematically, and include: * Vol.1: Nature and Scope * Vol. 2: Ethical Issues in Medicine, Technology and the Life Sciences * Vol. 3: Ethical Issues in Medicine, Technology and the Life Sciences II * Vol. 4: Environment * Vol. 5: Business/Economics * Vol. 6: Politics.

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.