Law and Ethics in Biomedical Research

Law and Ethics in Biomedical Research
Author: Duff William Ramus Waring
Publisher: University of Toronto Press
Total Pages: 281
Release: 2006-01-01
Genre: Medical
ISBN: 0802086438

When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.

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

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.

Biomedical Ethics and the Law

Biomedical Ethics and the Law
Author: James M. Humber
Publisher: Springer Science & Business Media
Total Pages: 716
Release: 2012-12-06
Genre: Philosophy
ISBN: 1468422235

In the past few years an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, suicide, and euthanasia. Malpractice suits abound and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of existing law further questioned. In the case of abortion, for example, the laws have changed radically, and the widely pub licized recent conviction of Dr. Edelin in Boston has done little to foster a moral consensus or even render the exact status of the law beyond reasonable question.

The Ethics of Biomedical Research

The Ethics of Biomedical Research
Author: Baruch A. Brody
Publisher: Oxford University Press, USA
Total Pages: 412
Release: 1998
Genre: Medical
ISBN: 9780195090079

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.

Routledge Handbook of Medical Law and Ethics

Routledge Handbook of Medical Law and Ethics
Author: Yann Joly
Publisher: Routledge
Total Pages: 607
Release: 2014-09-19
Genre: Law
ISBN: 1134448724

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.

Legal and Ethical Regulation of Biomedical Research in Developing Countries

Legal and Ethical Regulation of Biomedical Research in Developing Countries
Author: Remigius N. Nwabueze
Publisher: Routledge
Total Pages: 335
Release: 2016-04-22
Genre: Law
ISBN: 1317106423

There has been a rapid increase in the pace and scope of international collaborative research in developing countries in recent years. This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as the role of ethics committees. Providing a detailed analysis of the law of negligence and its application to research ethics committees and their members, common law and constitutional forms of action and potential negligence claims, the book concludes by suggesting new protocols and frameworks, improved regulation and litigation. This book will be a valuable guide for students, researchers, and policy-makers with an interest in medical law and ethics, bioethics, customary law in Africa and regulation in developing countries.

Islam and Biomedical Research Ethics

Islam and Biomedical Research Ethics
Author: Mehrunisha Suleman
Publisher: Routledge
Total Pages: 193
Release: 2020-07-07
Genre: Law
ISBN: 0429575424

This book is a contribution to the nascent discourse on global health and biomedical research ethics involving Muslim populations and Islamic contexts. It presents a rich sociological account about the ways in which debates and questions involving Islam within the biomedical research context are negotiated - a perspective which is currently lacking within the broader bioethics literature. The book tackles some key understudied areas including: role of faith in moral deliberations within biomedical research ethics, the moral anxiety and frustration experienced by researchers when having to negotiate multiple moral sources and how the marginalisation of women, the prejudice and abuse faced by groups such as sex workers and those from the LGBT community are encountered and negotiated in such contexts. The volume provides a valuable resource for researchers and scholars in this area by providing a systematic review of ethical guidelines and a rich case-based account of the ethical issues emerging in biomedical research in contexts where Islam and the religious moral commitments of Muslims are pertinent. The book will be essential for those conducting research in low and middle income countries that have significant Muslim populations and for those in Muslim-minority settings. It will also appeal to researchers and scholars in religious studies, social sciences, philosophy, anthropology and theology, as well as the fields of biomedical ethics, Islamic ethics and global health..

Biomedical Ethics and the Law

Biomedical Ethics and the Law
Author: James M. Humber
Publisher: Springer Science & Business Media
Total Pages: 645
Release: 2013-03-09
Genre: Philosophy
ISBN: 1461565618

In the past few years, an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, and euthanasia. Malpractice suits abound, and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of the existing law further questioned. Take abortion, for example. Rather than settling the legal issue, the Supreme Court's original abortion decision in Roe v. Wade (1973), seems only to have spurred further legal debate. And of course, whether or not abortion is a mo rally ac ceptable procedure is still the subject of heated dispute.