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.

Law/Ethics

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and "omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. - Features input from experts in the field dedicated to translating scientific research from bench to bedside and back - Provides expanded coverage of global clinical research - Contains hands-on, practical suggestions, illustrations, and examples throughout - Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

A legal reference for practicing physicians is a necessary adjunct to their professional practice library in today's highly regulated and litigious world. Medical Care Law was written to help practicing physicians avoid legal conflicts, and to prevent legal problems rather than treat them. Written with the practicing physician in mind, this book is also valuable to a variety of health professionals, including physician executives, medical directors, nurse administrators, advanced practice nurses, case managers, risk managers, legal nurse consultants, health care administrators, public health professionals, and attorneys. In addition To The traditional legal issues affecting medical practitioners, Medical Care Law addresses the legal pitfalls in today's volatile health care landscape, including managed care, health care fraud and abuse, compliance plans, and working with non-physician providers.

This unique Irish law book is a core text for any student of medicine, dentistry, radiography, physiotherapy, psychiatry or nursing, as well as legal practitioners advising clients in this area. Medical Law in Ireland (originally titled: Clinical Practice and the Law) brings together all applicable Irish law in an easy-to-read style and provides clear day-in day-out guidance for clinical practitioners, students and legal practitioners working in Ireland. This new edition sees an added emphasis on those areas of interest to legal practitioners, however there remains a wealth of information for those working in medical fields. Of particular note in this regard are the chapters on Clinical Negligence, Consent to Medical Treatment, End of Life, and Coroners Law and Other Issues arising after Death. These are all given in-depth treatments which provide the necessary information for those in day-to-day practice as well as those with an academic interest. Recent legislative changes are taken into account such as 2015's Montgomery vs Lanarkshire Health Board, as well as cases from the Medical Council. The two chapters on mental health reflect the growing importance need for clarity in this area. Author Simon Mills trained and qualified first as a doctor before moving into law. Now a barrister, he has specialized in medical law and brings both aspects of his experience to his work. His areas of particular interest are in clinical negligence, professional regulatory law, mental capacity and coroners' inquests.

Written by a highly respected academic and experienced textbook author, Medical Law: Core Text provides a lively and engaging overview of the key topics of the medical law syllabus.

Medical Law and Ethics covers the core legal principles, key cases, and statutes that govern medical law alongside the key ethical debates and dilemmas that exist in the field to ensure that the law is firmly placed in context. Carefully constructed features highlight these debates, drawing out the European angles, religious beliefs, and feminist perspectives which influence legal regulations. Other features such as 'a shock to the system', 'public opinion' and 'reality check' introduce further socio-legal aspects and contribute to the lively and engaging manner in which the subject is approached. Online Resource Centre This book is accompanied by an Online Resource Centre which includes: Bibliography and further reading Links to key cases Author video podcast Web links Links to key sites with information on medical law and ethics

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Published in conjunction with the American Health Information Management Association (AHIMA), the Fourth Edition of Medical Records and the Law is once again the ideal text for programs in HIM as well as a valuable reference resource for health professionals and those in the legal profession. Providing a useful resource to those in the legal profession, it addresses the substantial changes brought about by HIPAA and the growth of electronic health record systems and electronic data networks, retaining and updating the discussion of state laws affecting the use and disclosure of health informat

Replete with references to primary sources and the secondary literature, this major undertaking provides a comprehensive exposition of English medical law, from the organization of health care to the legal meaning of death.