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.
Download or read book How to Practice Academic Medicine and Publish from Developing Countries written by Samiran Nundy and published by Springer Nature. This book was released on 2021-10-23 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ethical Issues in Clinical Research written by Bernard Lo and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Issues in Medical Research Ethics written by Jürgen Boomgaarden and published by Berghahn Books. This book was released on 2003 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.
Download or read book Rethinking Health Care Ethics written by Stephen Scher and published by Springer. This book was released on 2018-08-02 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.
Download or read book Ethics and Regulation of Clinical Research written by Robert J. Levine and published by Yale University Press. This book was released on 1988-01-01 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. "[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine "Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine "You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal "Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology
Download or read book The Ethics of Biomedical Research written by Baruch A. Brody and published by Oxford University Press, USA. This book was released on 1998 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the many ethical issues related to biomedical research, including the use of animals in research, research on human subjects, clinical trials, international research ethics policies, and other related topics.
Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-05-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.
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 2009-10-16 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.
Download or read book Ethics in Medical Research written by Trevor Smith and published by Cambridge University Press. This book was released on 1999-08-12 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive guide for researchers to the ethical issues raised by different kinds of biomedical research.
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Download or read book Public Trust in Medical Research written by Philip Cheung and published by CRC Press. This book was released on 2016-07-06 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: It has been claimed by fertility experts that embryos can be screened for 6,000 diseases, thereby the risk of x-linked diseases can be minimised by 'cherry-picking' male embryos that do not carry the abnormal gene. If medical scientists continue to strive for cures, genetic aberrance in human could be a phenomenon of the past...This challenging book explores issues of professional integrity and ethics underpinning medical research. It includes real-life case studies where public trust in medical research has been misplaced and encourages medical professionals to adhere to professional codes of conduct and be informed about their decision making process. It is vital reading for undergraduate and postgraduate students of medicine, law, sociology and social policy, philosophy, health related research and ethics. Practising researchers in medicine and the pharmaceutical industry, and their managers will find it invaluable. The text provides motivation for academics and educators with an interest in research and governance. Healthcare policy makers and shapers, patient rights groups, campaigners and the general media will find the information enlightening. "Over the last four decades, medicine has given hope to many people and saved many lives as a result of the ability of the physicians and surgeons to develop new treatments and innovative surgical techniques. While we can celebrate the success of medical science, we should also critically examine some of these developments against principles and in the light of public opinion." - Philip Cheung.
Download or read book Medical Ethics in Clinical Practice written by Matjaž Zwitter and published by Springer. This book was released on 2019-01-04 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses medicine from an ethical perspective, whereas books on medical ethics more commonly present ethics from a bio-medical standpoint. The book is divided into 23 chapters. The introductory chapters present some basic concepts of medical ethics, such as the relation between the legal system and ethics, ethical documents, ethical theories, and ethical analysis. The following chapters address issues of importance in all fields of medicine: respecting autonomy, communication, relations within a healthcare team, professional malpractice, limited resources, and the portrait of a physician. In turn, the third part of the book focuses on ethical aspects in a broad range of medical activities – preventive medicine, human reproduction, genetics, pediatrics, intensive care, palliative medicine, clinical research, unproven methods in diagnostics and treatment, and the role of physicians who aren’t directly responsible for patient care. The last part presents students’ seminars with case stories. The book offers a valuable resource for physicians of all specialties, students of medicine, professionals, and students from other fields devoted to human health, journalists, and general readers with an interest in 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.
Download or read book The Ethics of Medical Research on Humans written by Claire Foster and published by Cambridge University Press. This book was released on 2001-09-13 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the three main approaches to moral decision-making. It is essential reading for all medical decision-makers.
Download or read book Dark Medicine written by William R. LaFleur and published by Indiana University Press. This book was released on 2008-07-17 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of essays looks at the dark medical research conducted during and after World War II. Contributors describe this research, how it was brought to light, and the rationalisations of those who perpetrated and benefited from it.