Download or read book Developing and Testing an Ethical Framework to Link International Clinical Research to Justice in Global Health written by Bridget Frances Pratt and published by . This book was released on 2012 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: The thesis considers whether international research should contribute to the reduction of global health disparities and, if so, how the enterprise should do so. To answer these questions, I systematically analyse cosmopolitan and middle ground theories of justice in order to determine if they support the conduct of international health research. I then investigate which theory, if any, can provide the most comprehensive guidance about what is owed by external research actors from high-income countries to parties in low and middle-income countries and is, therefore, best-equipped to serve as the basis of a justice framework for international research. The analysis reveals that the human rights cosmopolitan theories of Thomas Pogge and Henry Shue, Peter Singer's consequentialist cosmopolitan theory, and Jennifer Ruger's health capability paradigm each provide grounds for the contention that international research should advance justice in global health. Of these theories, the health capability paradigm is selected to serve as the starting point of a justice framework for international clinical research.Relying on premises derived from the health capability paradigm, I develop the 'research for health justice' framework. The framework provides guidance on how four key aspects of international clinical research should be structured so that the enterprise most effectively reduces health disparities between and within countries. Those four aspects are: the research target, research capacity strengthening, ancillary care, and post-trial benefits. The framework identifies the obligations of multilaterals, governments, research funders, sponsors, and investigators towards putting this model of international clinical research into practice.The thesis then utilises empirical methods to test the theoretical concepts that it develops. To determine whether high-income country governments meet their obligations under the 'research for health justice' framework, I evaluate the alignment of research law and policy in the United States and United Kingdom against its requirements. Neither country is shown to have enacted research law and policy similar to that called for by the framework. Due to their sustained commitment to technology transfer legislation, both countries' health research systems are organised to promote domestic economic ends rather than health equity. To establish whether and how research funders, sponsors, and investigators meet their obligations under the 'research for health justice' framework, case study research was performed on an ongoing equity-oriented international clinical trial-the Shoklo Malaria Research Unit's vivax malaria treatment trial. Data were collected utilising a mix of qualitative research methods and analysed according to the principles of thematic analysis. The results demonstrate that international clinical research can meet ethical requirements linking it to justice in global health, even in difficult circumstances (i.e., where a research population largely cannot access its government health system). Framework requirements were largely upheld by Wellcome Trust (funder), Oxford University (sponsor), and investigators on the vivax malaria treatment trial. A number of factors facilitated adherence to the requirements, including chief investigators' intentions and practices and the Shoklo Malaria Research Unit's dual role as a research unit and health care provider.

Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Download or read book Ethical Innovation for Global Health written by Chieko Kurihara and published by Springer Nature. This book was released on 2023-12-16 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume captures the recent changes and evolution in ethics in research involving humans and provides future directions to achieve alternative drug development strategies for equitable global health. It presents ethical considerations in current day clinical trials and new trends of ethics in research. It also describes the historical context, illustrates the process in alternative paradigms to achieve democracy after World War II, how the framework of ethics in research was established in different regions, and policies implemented to protect research participants from the exploitation of new drug development. The book is organized into three themed parts: relevant constructions from Brazil, South Africa, Taiwan, South Korea, and Japan; historical and international perspectives of principles of ethics in research; and alternative frameworks of clinical development and innovation. Ethical Innovation for Global Health: Pandemic, Democracy and Ethics in Research is an informative resource for academic researchers, the global pharmaceutical industry, regulators, civil society and other role players involved in global health. It is contributed to by leaders in global policy development in research ethics, and experts in drug development activities with its trajectory being global health. The COVID-19 pandemic, as a global disaster, necessitated not only socio-economic but also cultural transformation. While effective vaccines were developed under a successful new methodology, there remains inequity of distribution of these vaccines globally. The book re-engages with the notion of the primacy of distributing results of scientific innovation to those who most require the benefits.

Download or read book An Ethical Framework for Global Governance for Health Research written by Kiarash Aramesh and published by Springer Nature. This book was released on 2019-11-13 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive description and ethical analysis of one of the most challenging areas: international health research. Furthermore, it provides a vivid portrait of the current situation of global governance for health research and its main challenges and suggests a comprehensive and universal ethical framework based on the existing theories and frameworks. This work is a must-read for all the students, scholars, professionals, activists, and policy-makers who are involved or interested in the global health research enterprise and its governance and ethics.

Download or read book Globalization and Health written by Belinda Bennett and published by Springer Science & Business Media. This book was released on 2006-06-21 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within contemporary society, globalization has emerged as a key concern at the centre of ethical, legal and policy debates relating to health care. Conflicts between public interests and individual rights, the challenge of regulating health professionals and access to health services, and the effects of a global market all feature prominently in these discussions. As a result of globalization, these issues can no longer be understood solely within the political boundaries that define traditional notions of individuals and communities. Rather, solutions demand a global conception of rights and obligations, which in turn requires new approaches to health policy formulation and a reevaluation of existing ethical and legal frameworks. In essence, the impact of globalization on human health is testing the robustness of modern regulatory systems, legal doctrines and ethical paradigms. PUBLIC HEALTH: DEVELOPING GLOBAL CONCERNS The interconnectedness of the global economy presents new challenges in public health. While globalization has facilitated improvements in health care, it has also created new hazards and avenues for the exploitation of vulnerable persons. It is becoming increasingly apparent that both national and international responses are required. Indeed, as the chapters in this section convey, public health is rightly a global concern. Globalization has led to a sharing of both risks and responsibilities in public health. Belinda Bennett reminds us of the ease with which infectious diseases can spread within the global community, given the speed of modern travel and trade.

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Beyond Consent written by Jeffrey P. Kahn and published by Oxford University Press. This book was released on 1998-09-03 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patients with cancer and AIDS now clamor for access to clinical trials. Federal policies governing research that once emphasized protecting subjects from dangerous research now promote access to clinical research. Have claims about justice and access to the benefits of research eclipsed concerns about consent and protection from risks? How can we make good and fair decisions about the selection of subjects and other questions of justice in research? Beyond Consent examines the concept of justice and its application to human subject research through the different lenses of important research populations: children, the vulnerable sick, captive and convenient populations, women, people of color, and subjects in international settings. To set the stage for this examination, and introductory chapter addresses the evolution of research policies. After a look at specific subject populations, the authors discuss the concept of justice for research with human subjects in the future and analyze justice throughout the research enterprise.

Download or read book Exploitation and Developing Countries written by Jennifer S. Hawkins and published by Princeton University Press. This book was released on 2008-08-24 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction : Why exploitation? / Jennifer S. Hawkins and Ezekiel J. Emanuel -- Research ethics, developing countries, and exploitation : a primer / Jennifer S. Hawkins -- Case studies : the Havrix trial and the Surfaxin trial -- Exploitation in clinical research / Alan Wertheimer -- Testing our drugs on the poor abroad / Thomas Pogge -- Broadly utilitarian theories of exploitation and multinational clinical research / Richard J. Arneson -- Kantian ethics, exploitation, and multinational clinical trials / Andrew W. Siegel -- Exploitation and the enterprise of medical research / Alisa L. Carse and Margaret Olivia Little -- Exploitation and placebo controls / Jennifer S. Hawkins -- Addressing exploitation : reasonable availability versus fair benefits / Ezekiel J. Emanuel.

Download or read book Post Trial Access to Drugs in Developing Nations written by Evaristus Chiedu Obi and published by Springer. This book was released on 2017-07-26 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in developing countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries – patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular.

Download or read book Double Standards in Medical Research in Developing Countries written by Ruth Macklin and published by Cambridge University Press. This book was released on 2004-05-27 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.

Download or read book Ethical and Policy Issues in International Research Commissioned papers and staff analysis written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Ethical and Policy Issues in International Research Report and recommendations of the National Bioethics Advisory Commission written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book International Ethical Guidelines for Biomedical Research Involving Human Subjects written by Council for International Organizations of Medical Sciences and published by World Health Organization. This book was released on 1993 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Annexes.

Download or read book Moral Entanglements written by Henry S. Richardson and published by Oxford University Press. This book was released on 2012-09-04 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The philosopher Henry Richardson's short book is a defense of a position on a neglected topic in medical research ethics. Clinical research ethics has been a longstanding area of study, dating back to the aftermath of the Nazi death-camp doctors and the Tuskegee syphilis study. Most ethical regulations and institutions (such as Institutiional Review Boards) have developed in response to those past abuses, including the stress on obtaining informed consent from the subject. Richardson points out that that these ethical regulations do not address one of the key dilemmas faced by medical researchers -- whether or not they have obligations towards subjects who need care not directly related to the purpose of the study, termed "ancillary care obligations." Does a researcher testing an HIV vaccine in Africa have an obligation to provide anti-retrovirals to those who become HIV positive during the trial? Should a researcher studying a volunteer's brain scan, who sees a possible tumor, do more than simply refer him or her to a specialist? While most would agree that some special obligation does exist in these cases, what is the basis of this obligation, and what are its limits? Richardson's analysis of those key questions and the development of his own position are at the heart of this book, which will appeal to bioethicists studying research ethics, to policy makers, and to political and moral philosophers interested in the obligations of beneficence, one of the key issues in moral theory. " 'Philosophy recovers itself,' wrote John Dewey, 'when it ceases to be a device for dealing with the problems of philosophers and becomes a method, cultivated by philosophers, for dealing with the problems of men.' Henry Richardson confronts a problem in the ethics of medical research that is often (as his many real-life examples show) a matter of life and death. The problem is unexplored and quite difficult: Richardson finds he must craft new theory to deal with it. The theory he creates shows how we become morally entangled with others without intending to, as we enter into intimacies with them. This theory of moral entanglement is a genuine discovery in philosophy, with application across a wide range of human relationships. Since the theory was designed for medical researchers it also provides a bespoke ethical framework, as well as specific guidance, for researchers in the field. This book shows practical philosophy at its best: inspired by real problems, responding with powerful solutions." -- Leif Wenar, Chair of Ethics, King's College London "A medical researcher investigating transmission of malaria may find that a subject has another disease. Does the researcher have an obligation to devote some of the team's resources to treating this disease? The traditional principles of research ethics do not ask much less answer this important question. In this theoretically and practically rich book, Henry Richardson seeks to provide an answer and to identify issues that need further exploration. He argues that "ancillary care obligations" are explained by "moral entanglement" and cannot be justified by traditional principles of justice or the duty to rescue. He is admirably soft-hearted and tough-minded in combining his long demonstrated philosophical acuity with a deep knowledge of the problems on the ground. Richardson's book is characterized by great generosity towards those who need help, towards the problems faced by researchers, and towards the scholarly community - even those with whom he disagrees." - Alan Wertheimer, Senior Research Scholar, Department of Bioethics, National Institutes of Health "In this important book, Henry Richardson sculpts a new path for research ethics, one that focuses on ethical obligations of ancillary-care in clinical trials and medical research, particularly in developing countries, but with relevance throughout the world. In Moral Entanglements, Richardson extends the reach of his analysis both deep within and outside the research itself, recognizing the broader moral backdrop relevant for society-wide judgments of justice, and the special relationships that exist within the medical research context, about what is or is not owed research participants in situations of medical need. Rather than leave such important decisions up to the vagaries of politics or ad hoc assessments, this book sets out a comprehensive theoretical framework with principles to guide such decisions in the everyday lives of both medical researchers and research participants. This book significantly contributes to the ethics of ancillary-care in medical and public health research and judiciously enlightens questions and potential resolutions to these vital global and domestic problems." - Jennifer Prah Ruger, Associate Professor, Yale Schools of Public Health and Medicine

Download or read book Ethics in Global Health written by Ruth Macklin and published by Oxford University Press. This book was released on 2012-05-01 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a collection of Ruth Macklin's previously published articles that appeared in scholarly journals or as chapters in books. Dr. Macklin's pioneering work in ethics and global health spans more than two decades. The articles in this volume range from a chapter in a book published in 1989 to a journal article currently in press. The essays fall into two broad categories: policy and practice, and multinational research. Topics in the first category include cultural beliefs and attitudes regarding family planning, long-acting contraception, abortion, and more broadly, policies and practices affecting women's health. Two essays dealing with justice focus on HIV/AIDS: how developing country governments might distribute medications fairly to all who are in need; and what obligations do industrialized countries and world leaders have to provide affordable medications to developing countries. A theme that runs throughout the essays is a defense of the universality of ethical principles, despite cultural differences that exist around the globe. The section on multinational research includes articles on international ethics guidance documents, such as the Declaration of Helsinki; discussion of the obligations of researchers and sponsors when they conduct research in developing countries; what constitutes exploitation when research is conducted in resource-poor countries; and, as in the first section of the book, the application of universal ethical principles to the global research enterprise. The author criticizes the view that double standards in research are acceptable: one standard for rich countries, and a lower standard for developing countries. Several essays deal with sensitive and controversial ethical aspects of research on reproductive health and HIV/AIDS.