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Challenging Cases in Clinical Research Ethics

Challenging Cases in Clinical Research Ethics PDF Author: Benjamin Wilfond
Publisher:
ISBN: 9781032370958
Category : Clinical trials
Languages : en
Pages : 0

Book Description
Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features: - Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise - Supplemented by short introductions to each section - Focus on ethical rather than regulatory issues - Essential reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies.

Challenging Cases in Clinical Research Ethics

Challenging Cases in Clinical Research Ethics PDF Author: Benjamin Wilfond
Publisher:
ISBN: 9781032370958
Category : Clinical trials
Languages : en
Pages : 0

Book Description
Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features: - Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise - Supplemented by short introductions to each section - Focus on ethical rather than regulatory issues - Essential reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies.

Ethical Issues in Clinical Research

Ethical Issues in Clinical Research PDF Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
ISBN: 1451152779
Category : Medical
Languages : en
Pages : 302

Book Description
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor Settings PDF Author: Patricia A. Marshall
Publisher: World Health Organization
ISBN: 9241563389
Category : Medical
Languages : en
Pages : 89

Book Description
This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

Tough Decisions

Tough Decisions PDF Author: John M. Freeman
Publisher: Oxford University Press
ISBN: 9780195090420
Category : Medical
Languages : en
Pages : 246

Book Description
Tough Decisions places readers in realistic composites of cases the authors have actually seen or managed where they must make tough medical decisions. What happens in them often depends on the reader's decisions and thus gives a sense of pressures that bear on clinical-decision making.

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics PDF Author: Ezekiel J. Emanuel
Publisher: OUP USA
ISBN: 0199768633
Category : Medical
Languages : en
Pages : 848

Book Description
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

The Ethical Challenges of Human Research

The Ethical Challenges of Human Research PDF Author: Franklin G. Miller
Publisher: Oxford University Press
ISBN: 0199896208
Category : Law
Languages : en
Pages : 347

Book Description
This book contains 22 essays on the ethics of research involving human subjects written over a 15-year period. Topics addressed include the ethics of clinical trials, controversial study designs, and informed consent.

Research Ethics Consultation

Research Ethics Consultation PDF Author: Marion Danis
Publisher: OUP USA
ISBN: 0199798036
Category : Medical
Languages : en
Pages : 274

Book Description
The National Institutes of Health Clinical Center's Bioethics Consultation Service draws on a decade of experience to share a collection of their most interesting and informative research ethics consultations. The result is insight into the ethical issues that arise in clinical research and the practice of research ethics consultation.

Ethical and Legal Issues in Neurology

Ethical and Legal Issues in Neurology PDF Author: Timothy Lahey
Publisher: Elsevier Inc. Chapters
ISBN: 0128080876
Category : Medical
Languages : en
Pages : 472

Book Description
The increasing conduct of clinical research in low- and middle-income countries (LMIC) is motivated by the desire to promote host country access to biomedical research, to enhance LMIC access to modern clinical care, and opportunities to conduct research with simpler regulatory requirements and at lower cost. Yet clinical research in LMIC is associated with ethical risks beyond those of clinical research conducted in high-income countries (HIC). Ethical challenges particular to clinical research in LMIC include the conduct of placebo-controlled clinical trials in LMIC despite HIC availability of effective comparator interventions, obtaining informed consent despite power inequities, and the obligation of HIC researchers to redress health disparities in LMIC. This chapter covers these and additional ethical challenges of clinical research in LMIC, and proposes ways to navigate these challenges through awareness, regulatory oversight, consultation, and collaboration with LMIC investigators and community representatives. With its ethical challenges properly managed, clinical research in LMIC provides historic opportunities to bring biomedical research and better healthcare infrastructure to countries previously left behind in the modern rush to biomedical innovation.

Challenging Cases in Clinical Research Ethics

Challenging Cases in Clinical Research Ethics PDF Author: Benjamin S Wilfond
Publisher: CRC Press
ISBN: 1000989879
Category : Law
Languages : en
Pages : 518

Book Description
Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features: • Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise • Supplemented by short introductions to each section • Focus on ethical rather than regulatory issues • Essential reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies.

Ethics and Research with Children

Ethics and Research with Children PDF Author: Eric Kodish
Publisher: Oxford University Press
ISBN: 0195171780
Category : Medical
Languages : en
Pages : 376

Book Description
In this edited volume, a diverse group of scholars present and discuss challenging cases in the field of pediatric research ethics. After years of debate and controversy, fundamental questions about the morality of pediatric research persist: Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research that involves young children? What should be the role of the older child in decisions about research participation? How do the dynamics of hope and desperation influence decisions about research involving dying children? Should children or their parents be paid for participation in research? What about economic incentives for doctors, researchers and the pharmaceutical industry? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? Following an introductory overview by editor Eric David Kodish, the book is divided into three sections of case studies: Research Involving Healthy Children, Research Involving At Risk Children, and Research Involving Children with Serious Illness. Each case raises compelling ethical issues, and the analysis presented in each chapter illuminate the challenges posed across a wide spectrum of both research protocols and stories of individual case-based approach, this book provides a balanced and through account of the enduring dilemmas that arise when children become research subjects.