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. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

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. (shrink)

Policy makers from around the world are trying to emulate successful innovation systems in order to support economic growth. At the same time, innovation governance systems are being put in place to ensure a better integration of stakeholder views into the research and development process. In Europe, one of the most prominent and newly emerging governance frameworks is called Responsible Research and Innovation. This article aims to substantiate the following points: The concept of RRI and the concept of justice can (...) be used to derive similar ethical positions on the nano-divide. Given the ambitious policy aims of RRI, the concept may be better suited to push for ethical outcomes on access to nanotechnology and its products rather than debates based on justice issues alone. It may thus serve as a mediator concept between those who push solely for competitiveness considerations and those who push solely for justice considerations in nano-technology debates. The descriptive, non-normative Systems of Innovation approaches should be linked into RRI debates to provide more evidence on whether the approach advocated to achieve responsible and ethical governance of research and innovation can indeed deliver on competitiveness. (shrink)

Dying before one’s time has been a prominent theme in classic literature and poetry. Catherine Linton’s youthful death in Wuthering Heights leaves behind a bereft Heathcliff and generations of mourning readers. The author herself, Emily Brontë, died young from tuberculosis. John Keats’ Ode on Melancholy captures the transitory beauty of 19th century human lives too often ravished by early death. Keats also died of tuberculosis, aged 25. “The bloom, whose petals nipped before they blew, died on the promise of the (...) fruit” is how Percy Bysshe Shelley expressed his grief over Keats’ death. Emily Dickinson wrote So Has a Daisy Vanished, being driven into depression by the early loss of loved ones from typhoid and tuberculosis. (shrink)

In a widely cited 2003 article, DiMasi, Hansen, and Grabowski estimated the cost of pharmaceutical research and development to be $1.1 billion per new medicine coming onto the market in 2001. They also estimate that this cost is going up at a real rate of 7.4% annually. According to these estimates, the innovation cost per new medicine today is about $2.1 billion or $2.65 billion.