Clinical Trials In Latin America Where Ethics And Business Clash

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​

This book offers a first rate selection of academic articles on Latin American bioethics. It covers different issues, such as vulnerability, abortion, biomedical research with human subjects, environment, exploitation, commodification, reproductive medicine, among others. Latin American bioethics has been, to an important extent, parochial and unable to meet stringent international standards of rational philosophical discussion. The new generations of bioethicists are changing this situation, and this book demonstrates that change. All articles are written from the perspective of Latin American scholars from several disciplines such as philosophy and law. Working with the tools of analytical philosophy and jurisprudence, this book defends views with rational argument, and opening for pluralistic discussion.

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.

At the heart of research with human beings is the moral notion that the experimental subject is altruistic, and is primarily concerned for the welfare of others. Beneath the surface, however, lies a very different ethical picture. Individuals participating in potentially life-saving research sometimes take on considerable risks to their own well-being. Efforts to safeguard human participants in clinical trials have intensified ever since the first version of the World Medical Association's Declaration of Helsinki (1964) and are now codified in many national and international laws and regulations. However, a comprehensive understanding of how this cornerstone document originated, changed, and functions today does not yet exist in the sphere of human research. Ethical Research brings together the work of leading experts from the fields of bioethics, health and medical law, the medical humanities, biomedicine, the medical sciences, philosophy, and history. Together, they focus on the centrality of the Declaration of Helsinki to the protection of human subjects involved in experimentation in an increasingly complex industry and in the government-funded global research environment. The volume's historical and contemporary perspectives on human research address a series of fundamental questions: Is our current human protection regime adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science? How important has the Declaration been in non-Western regions, for example in Eastern Europe, Africa, China, and South America? Why has the bureaucratization of regulation led to calls to pay greater attention to professional responsibility? Ethical Research offers insight into the way in which philosophy, politics, economics, law, science, culture, and society have shaped, and continue to shape, the ideas and practices of human research.

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Global Research Ethics is a guide for students and their instructors as well as practitioners and researchers to understand topics linked to research ethics from a more global perspective. Research plays a key role in identifying health disparity trends and evaluating interventions to improve the health and well-being of the populations at the individual, local, national, and global levels. Conducting ethically sound research is imperative in these contexts. This book (a) uses case studies to offer examples of current research ethical dilemmas and (b) considers regulatory and cultural frameworks in a number of country contexts that highlight diverse methods of identifying and managing these ethical dilemmas. Chapters cover different types (groups) of participants, issues in research, and ways of doing research; then each chapter looks at least three exemplar case studies with at least two analytical commentaries. Case studies include health and social care research, and originate from countries such as Brazil, Chile, South Africa, Botswana, Australia and New Zealand, as well as the U.S. and U.K. The different viewpoints showcased will allow for dialogue to ensue about the ways in which populations and topics in research need to be conceptualized. Global Research Ethics is suitable for all undergraduates and postgraduates on research methods courses in the social and health sciences. It provides academic researchers, students, and community partners with guidelines to reflect on as they develop their own research studies.

The colonial heritage and its renewed aftermaths – expressed in the inter-American experiences of slavery, indigeneity, dependence, and freedom movements, to mention only a few aspects – form a common ground of experience in the Western Hemisphere. The flow of peoples, goods, knowledge and finances have promoted interdependence and integration that cut across borders and link the countries of North and South America together. The nature of this transversally related and multiply interconnected region can only be captured through a transnational, multidisciplinary, and comprehensive approach. The Routledge Handbook to the History and Society of the Americas explores the history and society of the Americas, placing particular emphasis on collective and intertwined experiences. Forty-four chapters cover a range of concepts and dynamics in the Americas from the colonial period until the present century: The shared histories and dynamics of Inter-American relationships are considered through pre-Hispanic empires, colonization, European hegemony, migration, multiculturalism, and political and economic interdependences. Key concepts are selected and explored from different geopolitical, disciplinary, and epistemological perspectives. Highlighting the contested character of key concepts that are usually defined in strict disciplinary terms, the Handbook provides the basis for a better and deeper understanding of inter-American entanglements. This multidisciplinary approach will be of interest to a broad array of academic scholars and students in history, sociology, political science cultural, postcolonial, gender, literary, and globalization studies.

A comprehensive and granular insight into the challenges of promoting rational medicine, this book serves as an essential resource for health policy makers and researchers interested in national medicines policies. Country-specific chapters have a common format, beginning with an overview of the health system and regulatory and policy environments, before discussing the difficulties in maintaining a medicines supply system, challenges in ensuring access to affordable medicines and issues impacting on rational medicine use. Numerous case studies are also used to highlight key issues and each chapter concludes with country-specific solutions to the issues raised. Written by highly regarded academics, the book includes countries in Africa, Asia, Europe, the Middle East and South America.