Global discussions are ongoing on how to stimulate antibiotic research and development in order to provide patients with new antibiotics able to address the challenges of antimicrobial resistance. In this supplement, we present nine articles derived from the research performed as part of the Innovative Medicine Initiative-funded DRIVE-AB project and others. These publications provide new evidence and arguments in the debate around economic incentives to stimulate antibiotic innovation, including characteristics, implementation and governance.

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s (...) when theoretical knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

There is a gap between the methods and techniques discussed in planning and management literature, and practitioners’ experiences of agricultural research and extension. This gap is attributable to the fact that outcomes of research and extension (R&E) initiatives are shaped by the interactions of contending coalitions that form around issues or approaches and promote or oppose them. This framework is used to elucidate the development of technologies and methodologies in the past. Implications are drawn for future planning (...) and management, based on seeing the use of methods and techniques in terms of the broader social and political contexts of research and development. (shrink)

Concern about the commercialization of research is rising, notably in testing new drugs. The problem involves oversimplified, polarizing assumptions about research and development (R&D) and intellectual property (IP). To address this problem this paper sets forth a more complex three phase RT&D process, involving Scientific Research (R), Technological Innovation (T), and Commercial Product Development (D) or the RT&D process. Scientific research and innovation testing involve costly intellectual work and do not produce free goods, but (...) rather require IP regulation. RT&D processes involve an unrecognized IP shift from a common IP right in public goods like information and knowledge to private IP in products and other hard assets. The question then is, what kind of IP right: private or common? Since scientific research and innovation testing require openness about adverse findings, and wide, low cost diffusion of results, they require a common, inclusive IP right. Common IP is appropriate to both sharing knowledge goods and recovering the cost of production. Research is furthermore compatible with commercialization and support by other social interests. On the other hand it is incompatible with the exclusionary private IP rights that permit restrictive publication or total suppression of information. Private IP rather than commercialization conflicts with the openness requirements of scientific research and innovation testing. Commercial funding, however, is in principle compatible with research and testing, especially when regulated by a common IP right. This reflects a pragmatic view of the fundamental interconnections of knowledge and other social interests. (shrink)

The traditional and emerging roles of the major research entities in the United States are reviewed. Particularly controversial has been the university's emerging role of applied researcher in addition to its traditional role of basic researcher. Private, for-profit research laboratories have vociferously objected to the funding of university applied research by both the federal government and private industry. The funding of university research by these latter two entities is then reviewed and discussed. In addition to the (...) ethical issue of whether university applied research should be funded, there is apparently another ethical issue regarding how the recipient universities are selected. In essence, if the universities intrusions are merely into untended areas, the first ethical issue seems less serious. Such may be the case if private laboratories are not equipped to perform the research. Of course, the second issue of which university should receive the funding remains. The apparently strengthening ties between universities and private industry are then reviewed. Direct ties between universities and industry still account for a very small part of university research. But impediments to cooperation are melting away as universities market their services to private industry. The authors contend that the government encourages cooperative ventures between universities and industry. They pose questions for all sides and suggest further areas of study should these joint ventures continue as they seem most likely to do. Much of the literature has leaned toward criticism of these joint efforts. Martin Kenney, in the February, 1987 issue of The Journal of Business Ethics, offered one of the more extensive efforts in his criticism of cooperative industrial/university research. Kenney concentrated on the area of biotechnology research. The present article avoids specific areas of research and takes a broad view of these cooperative research efforts. It is less critical than Kenney of the cooperation between industry and universities. (shrink)

In this paper we report on our experiences with using network analysis to discern and analyse ethical issues in research into, and the development of, a new wastewater treatment technology. Using network analysis, we preliminarily interpreted some of our observations in a Group Decision Room session where we invited important stakeholders to think about the risks of this new technology. We show how a network approach is useful for understanding the observations, and suggests some relevant ethical issues. We (...) argue that a network approach is also useful for ethical analysis of issues in other fields of research and development. The abandoning of the overarching rationality assumption, which is central to network approaches, does not have to lead to ethical relativism. (shrink)

This book provides a thorough introduction to research ethics and ethically responsible research practice in a research organization. It is relevant for all research areas. Morality, however, is not something one can just “learn”. Therefore, the book is written with a different basic tone than regular textbooks, so that it makes the reader aware of how morality plays a role in the various daily tasks one has in a research organization. The book conveys knowledge and (...) experience material about the society’s and the research community’s view of how different ethical issues should be solved. From this, the reader will acquire the basic ethical principles they need to know and understand and be aware of, in order to be qualified in an ethical context as employees of a research organization, and to be able to deal with common ethical issues associated with research. (shrink)

Nanomaterials have attracted much interest in the medical field and related applications as their distinct properties in the nanorange enable new and improved diagnosis and therapies. Owing to these properties and their potential interactions with the human body and the environment, the impact of nanomaterials on humans and their potential toxicity have been regarded a very significant issue. Consequently, nanomaterials are the subject of a wide range of cutting-edge research efforts in the medical and related fields to thoroughly probe (...) their potential beneficial utilizations and their more negative effects. We posit that the lack of standardization in the field is a serious shortcoming as it has led to the establishment of methods and results that do not ensure sufficient consistency and thus in our view can possibly result in research outputs that are not as robust as they should be. The main aim of this article is to present how NanoDiaRA, a large FP7 European multidisciplinary project that seeks to investigate and develop nanotechnology-based diagnostic systems, has developed and implemented robust, standardized methods to support research practices involving the engineering and manipulation of nanomaterials. First, to contextualize this research, an overview of the measures defined by different regulatory bodies concerning nanosafety is presented. Although these authorities have been very active in the past several years, many questions remain unanswered in our view. Second, a number of national and international projects that attempted to ensure more reliable exchanges of methods and results are discussed. However, the frequent lack of publication of procedures and protocols in research can often be a hindrance for sharing those good practices. Subsequently, the efforts made through NanoDiaRA to introduce standardized methods and techniques to support the development and utilization of nanomaterials are discussed in depth. A series of semi-structured interviews were conducted with the partners of this project, and the interviews were analyzed thematically to highlight the determined efforts of the researchers to standardize their methods. Finally, some recommendations are made toward the setting up of well-defined methods to support the high-quality work of collaborative nanoparticle-based research and development projects and to enhance standardization processes. (shrink)

In his paper entitled “Ethics and the Funding of Research and Development at Universities”1 Spier examines some of the potential problems of the relationship between 1) corporate sponsors of research and 2) the universities (and faculty) that receive that funding. Citing “He who pays the piper, calls the tune,” Spier suggests that a better way of funding research would be to “set up a dedicated publicly sponsored research establishment” with the stated goal of achieving particular (...) technical or engineering objectives. (Spier cited the successful Animal Virus Research of the UK as an example). Spier states that researchers at these establishments are “not subjected to the triple requirement to teach, research and administer as are university members, so they do not have to face the same ethical challenges of the academics.” This paper will examine the stated dangers of public/corporate research partnerships and whether the proposed alternative shares equally troubling ethical issues. (shrink)

Global science expansion and the ‘skills premium’ in labor markets have been extensively discussed in the literature on the global knowledge economy, yet the focus on, broadly-speaking, knowledge-related personnel as a key factor is surprisingly absent. This article draws on UIS and OECD data on research and development personnel for the period 1980 to 2015 for up to N = 82 countries to gauge cross-national trends and to test a wide range of educational, economic, political and institutional determinants (...) of general expansion as well as expansion by specific sectors and country groups. Findings show that, worldwide, the number of personnel involved in the creation of novel and original knowledge has risen dramatically in the past three decades, across sectors, with only a few countries reporting decrease. Educational and economic predictors show strong effects. Expansion is also strongest in those countries embedded in global institutional networks, yet regardless of a democratic polity. I discuss the emergence of ‘knowledge work’ as a mass-scale and worldwide phenomenon and map out consequences for the analysis of such a profound transformation, which involves both an educated workforce and the strong role of the state. (shrink)

Today there are multiple implantable medical devices on the market. The type of implants that interface the body’s tissues has been considered to have particular strong ethical implications. This article describes a development of a novel practice for ethical assessment and reflection within medical device research and development of non-CE marked medical devices, taking the perspective of both the ethicist and the researcher. The research case was an EU funded project where the aim was to develop (...) and compare the efficiency of invasive and non-invasive technological medical devices to create meaningful sensations as a novel therapy for phantom limb pain. An Independent Ethical Advisor with a regulatory and advisory role was assigned to the project, allowing us to investigate the projects deliberate incorporation of ethics. In the article we suggest and applied a novel framework based on action research for combining ethical assessment with building ethical reflection. The case analyse five different activities / elements: 1) the use of informed consent; 2) a survey amongst the research partners; 3) a workshop session; 4) observation of consortium meetings; and 5) an interview with a participating patient. (shrink)

The report entitled An Analysis of the Canadian Research and Development System for Agriculture/Food which was presented to the Science Council of Canada in July, 1991 contains many far-reaching recommendations for revisions of the research and educational components of the Agriculture/Food System in Canada. The report calls for research of holistic and interdisciplinary nature. It calls for determination of research priorities by broadly constituted committees which would include reporesentaitves heretofore not included in the process of (...) decisionmaking regarding scientific research. In addition, it calls for restructuring of the agricultural education system. The Co-editors of this Journal, believe that these recommendations should be wildely discussed and, therefore, requested publication of the Executive Summary of this Report. (shrink)

A crisis continues to brew within the pharmaceutical research and development (R&D) enterprise: productivity continues declining as costs rise, despite ongoing, often dramatic scientific and technical advances. To reverse this trend, we offer various suggestions for both the expansion and broader adoption of modeling and simulation (M&S) methods. We suggest strategies and scenarios intended to enable new M&S use cases that directly engage R&D knowledge generation and build actionable mechanistic insight, thereby opening the door to enhanced productivity. What (...) M&S requirements must be satisfied to access and open the door, and begin reversing the productivity decline? Can current methods and tools fulfill the requirements, or are new methods necessary? We draw on the relevant, recent literature to provide and explore answers. In so doing, we identify essential, key roles for agent-based and other methods. We assemble a list of requirements necessary for M&S to meet the diverse needs distilled from a collection of research, review, and opinion articles. We argue that to realize its full potential, M&S should be actualized within a larger information technology framework—a dynamic knowledge repository—wherein models of various types execute, evolve, and increase in accuracy over time. We offer some details of the issues that must be addressed for such a repository to accrue the capabilities needed to reverse the productivity decline. (shrink)

Artificial intelligence can be a game changer to address the global challenge of humanity-threatening climate change by fostering sustainable development. Since chemical research and development lay the foundation for innovative products and solutions, this study presents a novel chemical research and development process backed with artificial intelligence and guiding ethical principles to account for both process- and outcome-related sustainability. Particularly in ethically salient contexts, ethical principles have to accompany research and development powered by (...) artificial intelligence to promote social and environmental good and sustainability while preventing any harm for all stakeholders affected. (shrink)

An increase in the number of companies that publish corporate social responsibility (CSR) statements, and a rise in their ‘sustainability’ research, reflects a growing acceptance that broad ethical considerations are key for any type of company. However, little is known about how companies consider moral objectives for their research and development (R&D) activities, or the basis upon which these activities are chosen. This research involves qualitative investigation into Responsible Research and Innovation (RRI) in the Information (...) and Communication Technology (ICT) industry, comprising 30 in-depth, pan-European interviews with key personnel in the industry, and focus groups with employees at 14 different companies. Through investigation of the ‘responsible’ activities these companies currently undertake, we shed light on the types of moral goals they set and their underlying ethical standpoints. By reviewing both the responsible innovation and sustainability discourses, and presenting phenomenological evidence, we demonstrate that companies have adopted some aspects of RRI, even though it might not be recognised as such. Our findings indicate that these innovators recognise some of the ethical and societal concerns associated with their activities but their approach is often piecemeal; primary focus is upon the most immediate issues and on legal compliance, to the detriment of broader societal issues and wider challenges. We recommend explicit mechanisms that draw upon established ethical thought and practical academic work to improve companies' abilities to carry out their sustainability activities, and incorporate them into a responsible business strategy. We conclude with recommendations for innovators, corporate research and development, and policy. (shrink)

Shows how international biomedical researchers in Sri Lanka work across cultural, epistemic, economic, and power differences to accomplish clinical trials.

Neglected and tropical diseases, pervasive in developing countries, are important contributors to global health inequalities. They remain largely untreated due to lack of effective and affordable treatments. Resource-poor countries cannot afford to develop the public health interventions needed to control neglected diseases. In addition, neglected diseases do not represent an attractive market for pharmaceutical industry. Although a number of international commitments, stated in the Millennium Development Goals, have been made to avert the risk of communicable diseases, tropical diseases still (...) remain neglected due to delays in international assistance. This delay can be explained by the form international cooperation has generally taken, which is limited to promoting countries’ national interests, rather than social justice at a global level. This restricts the international responsibility for global inequalities in health to a humanitarian assistance. We propose an alternative view, arguing that expanding the scope of international cooperation by promoting shared health and economic value at a global level will create new opportunities for innovative, effective and affordable interventions worldwide. It will also promote neglected diseases as a global research priority. We build our argument on a proposal to replace the patenting system that currently regulates pharmaceutical research with a global fund to reward this research based on actual decreases in morbidity and mortality at a global level. We argue that this approach is beneficent because it will decrease global health inequalities and promote social justice worldwide. (shrink)

In previous research, we have argued that private companies should be more open with their scientific research findings. However, our research assumed, somewhat naively perhaps, that public institutions were quite open. Recent findings have suggested otherwise, and in this paper we explore the dilemma faced by industry, universities, and society in attempting to balance the needs of openness (to rapidly advance the body of knowledge), with secrecy (to protect the economic returns to a new innovation).

NCMRD initiated the Women in Management Research Program in January 1988. One of the objectives of the program is to help managers and policy makers deal with issues arising from women's increased participation in managerial and professional jobs backing research to help arrive at solutions to the problems being encountered both by institutions and by women themselves. Significant research funds have been raised from the private sector and ten projects have been funded to date. This article describes (...) the early development of the Program and its research mandate. (shrink)

The experience with genetically modified foods has been prominent in motivating science, industry and regulatory bodies to address the social and ethical dimensions of nanotechnology. The overall objective is to gain the general public’s acceptance of nanotechnology in order not to provoke a consumer boycott as it happened with genetically modified foods. It is stated implicitly in reports on nanotechnology research and development that this acceptance depends on the public’s confidence in the technology and that the confidence is (...) created on the basis of information, education, openness and debate about scientific and technological developments. Hence, it is assumed that informing and educating the public will create trust, which will consequently lead to an acceptance of nanotechnology. Thus, the humanities and social sciences are seen as tools to achieve public acceptance. In this paper, the author argues that this is a narrow apprehension of the role of the humanities and social sciences. The humanities and social sciences have a critical function asking fundamental questions and informing the public about these reflections. This may lead to scepticism, however, the motivation for addressing the social and ethical dimensions of nanotechnology should not be public acceptance but informed judgement. The author illustrates this critical function by discussing the role, motivation and contribution of ethics as an example. Lastly, the author shows that a possible strategy for incorporating the humanities and the social sciences into nanotechnology research and development is Real-Time Technology Assessment, where the purpose is to integrate natural science and engineering investigations with ethical, legal and social science from the outset. (shrink)

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented in (...) the first part of the paper. A number of objections to the idea are thereafter discussed and rejected. (shrink)

As a result of a gradual shifting of the resourcing of universities from the public to the private sector, the academic institution has been required to acquire some of its additional funding from industry via partnerships based on research and development. This paper examines this new condition and asks whether the different mission statements or modi operandi of the university vis à vis industry throws up additional ethical issues. While there are conditions where the interactions between industry and (...) the university may be seen to be between partners with some degree of equivalence, many such interactions, lacking this balance, are in danger of generating more concerns. It should also not be forgotten that independent publicly funded research establishments may also play an important role in the production of the innovation and development needed to maintain the strength of an industrial economy. (shrink)

The present article explores the rationales of scientists and engineers for distributing moral responsibilities related technology development. On the basis of a qualitative case study, it was investigated how the actors within a research network distribute responsibilities for these issues. Rawls’ Wide Reflective Equilibrium model was used as a descriptive framework. This study indicates that there is a correlation between the actors’ ethics position and their responsibility rationale. When discussing how to address ethical issues or how to distribute (...) the responsibility for addressing them, actors with similar normative background theories referred to the same type of normative arguments. It was found that these deliberative processes could best be interpreted in terms of an interplay between different layers of morality. The case suggests that people seek coherence between these layers rather than work through them one-directionally. By distinguishing between rationales for distributing responsibilities and the actual distributions, possible sources of misunderstanding can be identified. The benefit from acknowledging these different rationales is that it enables actors to recognize the legitimacy of other people’s opinions, ultimately contributing to a responsibility distribution that is both complete and accepted by all as justified. (shrink)

This paper surveys a sample of current research into the education of pupils with learning difficulties. Examples of the three major established research traditions are discussed, namely the psychomedical, organisational and sociological traditions. It is argued that much of this work seeks to extend the theoretical framework associated with one or another of these traditions, but fails to overcome the common limitation of reductionism. An emerging current of work is identified which adopts an anti-reductionist perspective. The characteristics of (...) the new approach are illustrated, and a specific need for further search within this framework, focusing on the dynamics of the school development process, is identified. (shrink)

The concept of mutual responsiveness is currently based on little empirical data in the literature of Responsible Research and Innovation. This paper explores RRI’s idea of mutual responsiveness in the light of recent RRI case studies on private sector research and development. In RRI, responsible innovation is understood as a joint endeavour of innovators and societal stakeholders, who become mutually responsive to each other in defining the ‘right impacts’ of the innovation in society, and in steering the (...) innovation towards realising those impacts. Yet, the case studies identified several reasons for why the idea of mutual responsiveness does not always appear feasible or desirable in actual R&D situations. Inspired by the discrepancies between theory and practice, we suggest three further elaborations for the concept of responsiveness in RRI. Process-responsiveness is suggested for identifying situations that require stakeholder involvement specifically during R&D. Product-responsiveness is suggested for mobilising the potential of innovation products to be adaptable according to diverse stakeholder needs. Presponsiveness is suggested as responsiveness towards stakeholders that are not reachable at a given time of R&D. Our aim is to contribute to a more tangible understanding of responsiveness in RRI, and suggest directions for further analysis in upcoming RRI case studies. (shrink)

New and Emerging Science and Technology (NEST) based innovations, e.g. in the field of Life Sciences or Nanotechnology, frequently raise societal and political concerns. To address these concerns NEST researchers are expected to deploy socially responsible R&D practices. This requires researchers to integrate social and ethical aspects (SEAs) in their daily work. Many methods can facilitate such integration. Still, why and how researchers should and could use SEAs remains largely unclear. In this paper we aim to relate motivations for NEST (...) researchers to include SEAs in their work, and the requirements to establish such integration from their perspectives, to existing approaches that can be used to establish integration of SEAs in the daily work of these NEST researchers. Based on our analyses, we argue that for the successful integration of SEAs in R&D practice, collaborative approaches between researchers and scholars from the social sciences and humanities seem the most successful. The only way to explore whether that is in fact the case, is by embarking on collaborative research endeavours. (shrink)

New and Emerging Science and Technology (NEST) based innovations, e.g. in the field of Life Sciences or Nanotechnology, frequently raise societal and political concerns. To address these concerns NEST researchers are expected to deploy socially responsible R&D practices. This requires researchers to integrate social and ethical aspects (SEAs) in their daily work. Many methods can facilitate such integration. Still, why and how researchers should and could use SEAs remains largely unclear. In this paper we aim to relate motivations for NEST (...) researchers to include SEAs in their work, and the requirements to establish such integration from their perspectives, to existing approaches that can be used to establish integration of SEAs in the daily work of these NEST researchers. Based on our analyses, we argue that for the successful integration of SEAs in R&D practice, collaborative approaches between researchers and scholars from the social sciences and humanities seem the most successful. The only way to explore whether that is in fact the case, is by embarking on collaborative research endeavours. (shrink)

Ontology is a burgeoning field, involving researchers from the computer science, philosophy, data and software engineering, logic, linguistics, and terminology domains. Many ontology-related terms with precise meanings in one of these domains have different meanings in others. Our purpose here is to initiate a path towards disambiguation of such terms. We draw primarily on the literature of biomedical informatics, not least because the problems caused by unclear or ambiguous use of terms have been there most thoroughly addressed. We advance a (...) proposal resting on a distinction of three levels too often run together in biomedical ontology research: 1. the level of reality; 2. the level of cognitive representations of this reality; 3. the level of textual and graphical artifacts. We propose a reference terminology for ontology research and development that is designed to serve as common hub into which the several competing disciplinary terminologies can be mapped. We then justify our terminological choices through a critical treatment of the ‘concept orientation’ in biomedical terminology research. (shrink)

Non-lethal weapons have become an increasingly important class of weapons. Creating these armaments requires examination of ethical issues in their research and development processes. Chief a...