Law/Ethics

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.

Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.ContributorsAdam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

Corporate Legal Compliance Handbook, Third Edition, provides the knowledge necessary to implement or enhance a compliance program in a specific company, or in a client's company. The book focuses not only on doing what is legal or what is right--the two are both important but not always the same--but also on how to make a compliance program actually work. The book is organized in a sequence that follows how to approach a compliance program. It gives the compliance officer, consultant, or attorney a good grounding in the basics of compliance law. This includes such things as the rules about corporate and individual liability, an understanding of the basics of the key laws that impact companies, and the workings of the U.S. Sentencing Guidelines. Successful programs also require an understanding of educational techniques, good communication skills, and the use of computer tools. The effective compliance program also takes into account how to deliver messages using a variety of media to reach employees in different locations, of different ages or education, who speak different languages. Note: Online subscriptions are for three-month periods.

Written for virtually every professional and leader in the health care field, as well as students who are preparing for careers in health services delivery, this book presents a framework for developing a patient safety program, shows how best to examine events that do occur, and reveals how to ensure that appropriate corrective and preventative actions are reviewed for effectiveness. The book covers a comprehensive selection of topics including The link between patient safety and legal and regulatory compliance The role of accreditation and standard-setting organizations in patient safety Failure modes and effect analysis Voluntary and regulatory oversight of medical error Evidence-based outcomes and standards of care Creation and preservation of reports, data, and device evidence in medical error situations Claims management when dealing with patient safety events Full disclosure Patient safety in human research Managing confidentiality in the face of litigation Managing patient safety compliance through accountability-based credentialing for health care professionals Planning for the future

Continuing its superiority in the health care risk management field, this sixth edition of The Risk Management Handbook for Health Care Organizations is written by the key practitioners and consultant in the field. It contains more practical chapters and health care examples and additional material on methods and techniques of risk reduction and management. It also revises the structure of the previous edition, and focuses on operational and organizational structure rather than risk areas and functions. The three volumes are written using a practical and user-friendly approach.

Mandated Benefits 2015 Compliance Guide is a comprehensive and practical reference manual covering key federal regulatory issues that must be addressed by human resources managers, benefits specialists, and company executives in all industries. Mandated Benefits 2015 Compliance Guide includes in-depth coverage of these and other major federal regulations: Patient Protection and Affordable Care Act (PPACA) Health Information Technology for Economic and Clinical Health (HITECH) Act Mental Health Parity and Addiction Equity Act (MHPAEA) Genetic Information Nondiscrimination Act (GINA) Americans with Disabilities Act (ADA) Employee Retirement Income Security Act (ERISA) Health Insurance Portability and Accountability Act (HIPAA) Heroes Earnings Assistance and Relief Tax Act (HEART Act) Consolidated Omnibus Budget Reconciliation Act (COBRA) Mandated Benefits 2015 Compliance Guide helps take the guesswork out of managing employee benefits and human resources by clearly and concisely describing the essential requirements and administrative processes necessary to comply with each regulation. It offers suggestions for protecting employers against the most common litigation threats and recommendations for handling various types of employee problems. Throughout the Guide are numerous exhibits, useful checklists and forms, and do's and don'ts. A list of HR audit questions at the beginning of each chapter serves as an aid in evaluating your company's level of regulatory compliance. Mandated Benefits 2015 Compliance Guide has been updated to include: The Dodd Frank Act, creating an ethics training program, and practices and trends Information on payroll cards and Federal Insurance Contributions Act (FICA) tip credit New regulations and guidelines for health care reform as mandated by the Patient Protection and Affordable Care Act (PPACA) Updated requirements for certificates of creditable coverage; excepted benefits under the Health Insurance Portability and Accountability Act (HIPAA); and transaction standards The revised model general and election notices as required under PPACA Qualified Longevity Annuity Contracts and definition of spouse per the Supreme Court ruling in United States v. Windsor and updates to the Pension Benefit Guaranty Corporation's required premiums The payment of long-term disability insurance by qualified retirement plans PPACA's effect on health reimbursement arrangements; new information on the proposed $500 carryover of unused funds in health flexible spending arrangements (FSAs) and PPACA's effect on health FSAs; new material on the effect of amendments to HIPAA's excepted benefit rules on Employee Assistance Programs; and revised information on providing employee benefits to legally married same-sex couples based on the Supreme Court's decision in United States v. Windsor and the decision's effect on cafeteria plan mid-year election changes New sections on "no-fault" attendance policies and pregnancy and the Americans with Disabilities Act Information on the definition of spouse based on the Supreme Court ruling in United States v. Windsor New material on the proposed Equal Pay Report

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.