Clinical Trials In Latin America Where Ethics And Business Clash

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Clinical Trials in Latin America: Where Ethics and Business Clash

Author : Nuria Homedes
Publisher : Springer Science & Business Media
ISBN 13 : 3319013637
Total Pages : 301 pages
Book Rating : 4.3/5 (19 download)

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Book Synopsis Clinical Trials in Latin America: Where Ethics and Business Clash by : Nuria Homedes

Download or read book Clinical Trials in Latin America: Where Ethics and Business Clash written by Nuria Homedes and published by Springer Science & Business Media. This book was released on 2013-11-29 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Controversies in Latin American Bioethics

Author : Eduardo Rivera-López
Publisher : Springer
ISBN 13 : 303017963X
Total Pages : 243 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis Controversies in Latin American Bioethics by : Eduardo Rivera-López

Download or read book Controversies in Latin American Bioethics written by Eduardo Rivera-López and published by Springer. This book was released on 2019-06-19 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bioethics and Vulnerability

Author : Florencia Luna
Publisher : Rodopi
ISBN 13 : 9042020733
Total Pages : 205 pages
Book Rating : 4.0/5 (42 download)

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Book Synopsis Bioethics and Vulnerability by : Florencia Luna

Download or read book Bioethics and Vulnerability written by Florencia Luna and published by Rodopi. This book was released on 2006 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents some of the challenges bioethics in Latin America faces today. It considers them through the lenses of vulnerable populations, those incapable of protecting their own interests, such as the illiterate, women in societies disrespectful of their reproductive rights, and research subjects in contexts where resources are scarce.

Global Clinical Trials

Author : Richard Chin
Publisher : Academic Press
ISBN 13 : 9780123815385
Total Pages : 522 pages
Book Rating : 4.8/5 (153 download)

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Book Synopsis Global Clinical Trials by : Richard Chin

Download or read book Global Clinical Trials written by Richard Chin and published by Academic Press. This book was released on 2011-05-06 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Ethical Innovation for Global Health

Author : Chieko Kurihara
Publisher : Springer Nature
ISBN 13 : 9819961637
Total Pages : 331 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Ethical Innovation for Global Health by : Chieko Kurihara

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.

Ethical Research

Author : Ulf Schmidt
Publisher : Oxford University Press
ISBN 13 : 0190224185
Total Pages : 496 pages
Book Rating : 4.1/5 (92 download)

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Book Synopsis Ethical Research by : Ulf Schmidt

Download or read book Ethical Research written by Ulf Schmidt and published by Oxford University Press. This book was released on 2020-04-21 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Global Clinical Trials Playbook

Author : Menghis Bairu
Publisher : Academic Press
ISBN 13 : 0124158609
Total Pages : 320 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis Global Clinical Trials Playbook by : Menghis Bairu

Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-06-12 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Global Research Ethics

Author : Caren J. Frost
Publisher : Taylor & Francis
ISBN 13 : 1000898431
Total Pages : 183 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Global Research Ethics by : Caren J. Frost

Download or read book Global Research Ethics written by Caren J. Frost and published by Taylor & Francis. This book was released on 2023-06-29 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Routledge Handbook to the History and Society of the Americas

Author : Olaf Kaltmeier
Publisher : Routledge
ISBN 13 : 1351138693
Total Pages : 490 pages
Book Rating : 4.3/5 (511 download)

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Book Synopsis The Routledge Handbook to the History and Society of the Americas by : Olaf Kaltmeier

Download or read book The Routledge Handbook to the History and Society of the Americas written by Olaf Kaltmeier and published by Routledge. This book was released on 2019-04-12 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Policy in Countries with Developing Healthcare Systems

Author : Zaheer-Ud-Din Babar
Publisher : Springer
ISBN 13 : 3319516736
Total Pages : 430 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Pharmaceutical Policy in Countries with Developing Healthcare Systems by : Zaheer-Ud-Din Babar

Download or read book Pharmaceutical Policy in Countries with Developing Healthcare Systems written by Zaheer-Ud-Din Babar and published by Springer. This book was released on 2017-03-27 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Humanity and Inhumanity in the German-Speaking World

Author : Mererid Puw Davies
Publisher : UCL Press
ISBN 13 : 1787357716
Total Pages : 240 pages
Book Rating : 4.7/5 (873 download)

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Book Synopsis Medical Humanity and Inhumanity in the German-Speaking World by : Mererid Puw Davies

Download or read book Medical Humanity and Inhumanity in the German-Speaking World written by Mererid Puw Davies and published by UCL Press. This book was released on 2020-04-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Humanity and Inhumanity in the German-Speaking World is the first volume dedicated to exploring the interface of medicine, the human and the humane in the German-speaking lands. The volume tracks the designation and making through medicine of the human and inhuman, and the humane and inhumane, from the Middle Ages to the present day. Eight individual chapters undertake explorations into ways in which theories and practices of medicine in the German-speaking world have come to define the human, and highlight how such theories and practices have consolidated, or undermined, notions of humane behaviour. Cultural analysis is central to this investigation, foregrounding the reflection, refraction and indeed creation of these theories and practices in literature, life-writing and other discourses and media. Contributors bring to bear perspectives from literary studies, film studies, critical theory, cultural studies, history, and the history of medicine and psychiatry. Thus, this collection is historical in the most expansive sense, for it debates not only what historical accounts bring to our understanding of this topic. It encompasses too investigation of life-writing, documentary, and theory and literary works to bring to light elusive, paradoxical, underexplored – yet vital – issues in history and culture.

White Coat, Black Hat

Author : Carl Elliott
Publisher : Beacon Press
ISBN 13 : 0807061441
Total Pages : 233 pages
Book Rating : 4.8/5 (7 download)

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Book Synopsis White Coat, Black Hat by : Carl Elliott

Download or read book White Coat, Black Hat written by Carl Elliott and published by Beacon Press. This book was released on 2011-09-13 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: By New Yorker and Atlantic writer Carl Elliott, a readable and even funny account of the serious business of medicine. A tongue-in-cheek account of the changes that have transformed medicine into big business. Physician and medical ethicist Carl Elliott tracks the new world of commercialized medicine from start to finish, introducing the professional guinea pigs, ghostwriters, thought leaders, drug reps, public relations pros, and even medical ethicists who use medicine for (sometimes huge) financial gain. Along the way, he uncovers the cost to patients lost in a health-care universe centered around consumerism.

Ethical Conduct of Clinical Research Involving Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Conflict of Interest in Medical Research, Education, and Practice

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309145449
Total Pages : 436 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Conflict of Interest in Medical Research, Education, and Practice by : Institute of Medicine

Download or read book Conflict of Interest in Medical Research, Education, and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Code of Ethics for Nurses with Interpretive Statements

Author : American Nurses Association
Publisher : Nursesbooks.org
ISBN 13 : 1558101764
Total Pages : 42 pages
Book Rating : 4.5/5 (581 download)

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Book Synopsis Code of Ethics for Nurses with Interpretive Statements by : American Nurses Association

Download or read book Code of Ethics for Nurses with Interpretive Statements written by American Nurses Association and published by Nursesbooks.org. This book was released on 2001 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pamphlet is a succinct statement of the ethical obligations and duties of individuals who enter the nursing profession, the profession's nonnegotiable ethical standard, and an expression of nursing's own understanding of its commitment to society. Provides a framework for nurses to use in ethical analysis and decision-making.

Women and Health Research

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030904992X
Total Pages : 286 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Women and Health Research by : Institute of Medicine

Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Clinical Ethics

Author : Albert R. Jonsen
Publisher : McGraw-Hill Companies
ISBN 13 :
Total Pages : 212 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Clinical Ethics by : Albert R. Jonsen

Download or read book Clinical Ethics written by Albert R. Jonsen and published by McGraw-Hill Companies. This book was released on 1992 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Ethics introduces the four-topics method of approaching ethical problems (i.e., medical indications, patient preferences, quality of life, and contextual features). Each of the four chapters represents one of the topics. In each chapter, the authors discuss cases and provide comments and recommendations. The four-topics method is an organizational process by which clinicians can begin to understand the complexities involved in ethical cases and can proceed to find a solution for each case.