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Women and Health Research

Women and Health Research
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 261
Release: 1994-01-01
Genre: Medical
ISBN: 0309176867

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There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.


Healthcare Research Ethics and Law

Healthcare Research Ethics and Law
Author: Hazel Biggs
Publisher: Routledge
Total Pages: 233
Release: 2009-10-16
Genre: Law
ISBN: 1135309272

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The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.


Clinical Research and the Law

Clinical Research and the Law
Author: Patricia M. Tereskerz
Publisher: John Wiley & Sons
Total Pages: 295
Release: 2012-04-24
Genre: Medical
ISBN: 1118272161

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CLINICAL RESEARCH AND THE LAW The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including: standards and duty of care conflicts of interest establishing clinical trials informed consent research contracts the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.


Manual for Research Ethics Committees

Manual for Research Ethics Committees
Author: Sue Eckstein
Publisher: Cambridge University Press
Total Pages: 584
Release: 2003-02-20
Genre: Law
ISBN: 9780521810043

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The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.


Ethics and Regulation of Clinical Research

Ethics and Regulation of Clinical Research
Author: Robert J. Levine
Publisher: Yale University Press
Total Pages: 484
Release: 1988-01-01
Genre: Language Arts & Disciplines
ISBN: 9780300042887

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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


Medical Ethics and Law

Medical Ethics and Law
Author: Dominic Wilkinson
Publisher: Elsevier Health Sciences
Total Pages: 278
Release: 2008-03-06
Genre: Medical
ISBN: 0443103372

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This is a short textbook of ethics and law aimed primarily at medical students. The book is in two sections. The first considers general aspects of ethics (in the context of medicine); the second section covers the topics identified in the 'consensus agreement'. The content of medical law is not intended to be comprehensive and relates very much to the ethical issues. The law will be updated throughout including: consent in light of Mental Capacity Act; mental health law in light of Mental Health Act; end of life (depending on outcome of Burke case and the passage of the Joffe Bill); assisted reproduction in light of expected changes in HFEA. New guidelines to be added: the guidelines and processes around medical research are under review and likely to develop and change; GMC guidelines are under continual revision (the Burke case in particular may have direct impact, but it is also likely that the confidentiality guidelines will undergo revision particularly in view of the increasing importance of genetic data). The new legal aspects outlined above will require some changes to the ethical analysis: the ethical issues of new technology will be included (cloning; transgenesis and chimera, i.e. forming organisms from more than one species) and stem-cells; resource allocation ethics is moving on to examining a wider range of issues than covered in the first edition and this will be discussed; the whole area of mental disorder and capacity to consent is an active area of ethical research and the second edition would cover some of this new work.


Privacy, Confidentiality, and Health Research

Privacy, Confidentiality, and Health Research
Author: William W. Lowrance
Publisher: Cambridge University Press
Total Pages: 203
Release: 2012-06-21
Genre: Law
ISBN: 1139510827

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The potential of the e-health revolution, increased data sharing, database linking, biobanks and new techniques such as geolocation and genomics to advance human health is immense. For the full potential to be realized, though, privacy and confidentiality will have to be dealt with carefully. Problematically, many conventional approaches to such pivotal matters as consent, identifiability, and safeguarding and security are inadequate. In many places, research is impeded by an overgrown thicket of laws, regulations, guidance and governance. The challenges are being heightened by the increasing use of biospecimens, and by the globalization of research in a world that has not globalized privacy protection. Drawing on examples from many developed countries and legal jurisdictions, the book critiques the issues, summarizes various ethics, policy, and legal positions (and revisions underway), describes innovative solutions, provides extensive references and suggests ways forward.


Ethics and Law in Modern Medicine

Ethics and Law in Modern Medicine
Author: D. Vukadinovich
Publisher: Springer Science & Business Media
Total Pages: 254
Release: 2013-03-09
Genre: Philosophy
ISBN: 9401596743

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Ethics and Law in Modern Medicine is a unique book that explores the field of medical ethics and health care decision-making through hypothetical case studies. The truly unique feature of this volume is that each chapter sets forth a hypothetical fact pattern which includes role assignments to encourage participants to actively take part in group discussions and debate the controversial and cutting-edge topics that are presented. Each chapter includes in-depth discussion questions which thoroughly explore issues raised by the hypothetical fact patterns, and suggested readings provide background for participants. Additionally, the volume contains excerpts from key statutes and case law which govern the decision-making process presented in each chapter. The volume covers a wide variety of issues including HIV, the health care rights of minors, consent and confidentiality, assisted reproductive technology, property rights in bodily organs, research ethics, religious freedom and the right to refuse care, rationing of scarce resources, surrogate decision-making, and several other traditional as well as unique ethical, legal, and social issues.


Ethics, Law and Professional Issues

Ethics, Law and Professional Issues
Author: Ann Gallagher
Publisher: Bloomsbury Publishing
Total Pages: 145
Release: 2012-03-22
Genre: Medical
ISBN: 1350310727

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This practice-based textbook explores the ethical, legal and professional issues that characterise the field of healthcare. From seeking consent to upholding patient confidentiality, it examines a broad range of professional dilemmas from everyday practice. Detailed scenarios and engaging discussions help the reader understand how best to balance ethics, the law and professional codes of conduct in order to provide the best standards of care. Whether studying on an undergraduate nursing, midwifery or healthcare related programme or an experienced practitioner, this is essential resource for people working in healthcare looking to develop an ethically, legally and professionally sound approach to practice.