I. Glenn Cohen

Holly Fernandez Lynch

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. Contributors Adam 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

Perspectives on the Future

Human Subjects Research Regulation

Barbara E. Bierer

Suzanne M. Rivera

Legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in research using human biospecimens. Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research. After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators. Contributors Rebecca A. Anderson, Heide Aungs, Avery Avrakotos, Mark Barnes, Jill Barnholtz-Sloan, Benjamin Berkman, Barbara E. Bierer, Mark A. Borreliz, Jeffrey R. Botkin, Dan Brock, Ellen Wright Clayton, I. Glenn Cohen, Lisa Eckstein, Barbara J. Evans, Emily Chi Fogler, Nanibaa' A. Garrison, Pamela Gavin, Aaron J. Goldenberg, Christine Grady, Kate Gallin Heffernan, Marylana Saadeh Helou, Sara Chandros Hull, Elisa A. Hurley, Steven Joffe, Erin P. Johnson, Julie Kaneshiro, Aaron S. Kesselheim, Isaac Kohane, David Korn, Russell Korobkin, Bernard Lo, Geoffrey Lomax, Kimberly Hensle Lowrance, Holly Fernandez Lynch, Bradley A. Malin, Karen J. Maschke, Eric M. Meslin, P. Pearl O'Rourke, Quinn T. Ostrom, David Peloquin, Rebecca Pentz, Jane Perlmutter, Ivor Pritchard, Suzanne M. Rivera, Erin Rothwell, Andrew P. Rusczek, Rachel E. Sachs, Carol Weil, David Wendler, Benjamin Wilfond, Susan M. Wolf

Ethics and Policy Implications

Specimen Science

Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research. After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators.

The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law, with contributions from the most eminent scholars in the field. The Handbook paints with broad thematic strokes the major features of American healthcare law and policy, its recent reforms including the Affordable Care Act, its relationship to medical ethics and constitutional principles, and how it compares to the experience of other countries. It explores the legal framework for the patient experience, from access through treatment, to recourse (if treatment fails), and examines emerging issues involving healthcare information, the changing nature of healthcare regulation, immigration, globalization, aging, and the social determinants of health. This Handbook provides valuable content, accessible to readers new to the subject, as well as to those who write, teach, practice, or make policy in health law.

The Oxford Handbook of U.S. Healthcare Law

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

The Challenges of Regulating Drugs and New Technologies

FDA in the Twenty-First Century

The Globalization of Health Care is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas - medical tourism, medical migration (the physician "brain drain"), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented.

Legal and Ethical Issues

The Globalization of Health Care

Mark A. Hall

David Orentlicher

Mary Anne Bobinski

Financial and ethical issues are integrated into this concise and engaging treatment of Bioethics and Public Health Law. The complex relationship between patients, providers, the state, and public health institutions are explored through high-interest cases, informative notes, and compelling problems. The updated Fourth Edition includes recent cases and developments in biotechnology, including stem cell research and gene patents, and updates to HIPPA coverage, DNA research, and bio-banks. Discussions of confidentiality and informed consent include new legislative and judicial responses to posthumous reproduction and the challenges arising from international reproductive tourism.

Bioethics and Public Health Law

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

Henry T. Greely

Carmel Shachar

Nita A. Farahany

Examines the ethical, legal, and regulatory challenges presented as genomics become commonplace, easily available consumer products.

Ethical and Legal Considerations

Consumer Genetic Technologies

Nicholas Bagley

Health Care Law and Ethics, Ninth Edition offers a relationship-oriented approach to health law—covering the essentials, as well as topical and controversial subjects. The book provides thoughtful and teachable coverage of every aspect of health care law. Current and classic cases build logically from the fundamentals of the patient/provider relationship to the role of government and institutions in health care. The book is adaptable to both survey courses and courses covering portions of the field. Key Features: New authors Nick Bagley and Glenn Cohen Incorporated anticipated changes to the Affordable Care Act More current cases and more streamlined notes, including ones on medical malpractice, bioethics, and on finance and regulation More coverage of “conscientious objection” and “big data” - Discussion of new “value based” methods of physician payment - Expanded coverage of “fraud and abuse” Current issues in public health (e.g., Ebola, Zika) and controversies in reproductive choice (e.g., Hobby Lobby) Coverage of cutting-edge genetic technologies (e.g., gene editing and mitochondrial replacement)

Health Care Law and Ethics

Anita Silvers

Michael Ashley Stein

Examines how the framing of disability has serious implications for legal, medical, and policy treatments of disability.

Disability, Health, Law, and Bioethics

Allison Hoffman

William M. Sage

The Oxford Handbook of U.S. Health Law

Nir Eyal

Norman Daniels

The identified lives effect describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. For example, during the August 2010 gold mine cave-in in Chile, where ten to twenty million dollars was spent by the Chilean government to rescue the 33 miners trapped underground. Rather than address the many, more cost effective mine safety measures that should have been implemented, the Chilean government and international donors concentrated efforts in large-scale missions that concerned only the specific group. Such bias as illustrated through this incident raises practical and ethical questions that extend to almost every aspect of human life and politics. What can social and cognitive sciences teach us about the origin and triggers of the effect? Philosophically and ethically, is the effect a "bias" to be eliminated or is it morally justified? What implications does the effect have for health care, law, the environment and other practice domains? This volume is the first to take an interdisciplinary approach toward answering this issue of identified versus statistical lives by considering a variety of perspectives from psychology, public health, law, ethics, and public policy.

An Interdisciplinary Perspective

Identified Versus Statistical Lives

Focuses on patients traveling for cardiac bypass and other legal services to places like India, Thailand and Mexico, and analyzes issues of quality of care, disease transmission, liability, private and public health insurance and the effects of this trade on foreign health care systems.

Medical Tourism, Law, and Ethics

Patients with Passports

Christopher T. Robertson

Behaviorally informed health policy? : patient autonomy, active choosing, and paternalism / Cass R. Sunstein -- Three choice architecture paradigms for healthcare policy / Russell Korobkin -- Can behavioral economics save healthcare reform? / Alan M. Garber -- Seven ways of applying behavioral science to health policy / Michael Hallsworth -- What can PPACA teach us about behavioral law & economics? / David A. Hymen and Thomas S. Ulen -- Bad medicine : does the unique nature of healthcare decisions justify nudges? / Mark D. White -- Nudging and benign manipulation for health / Nir Eyal -- The political morality of nudges in healthcare / Jonathan Gingerich -- An ethical framework for public health nudges: a case study of incentives as nudges for vaccination in rural india / Jennifer Blumenthal-Barby, Zainab Shipchandler, and Julika Kaplan -- Behavioral economics and food policy : the limits of nudging / Andrea Freeman -- Cost-sharing as choice architecture / Christopher T. Robertson -- Using behavioral economics to promote physicians' prescribing of generic drugs and follow-on biologics : what are the issues? / Ameet Sarpatwari, Niteesh K. Choudhry, Jerry Avorn, and Aaron S. Kesselheim -- Towards behaviorally informed policies for consumer credit decisions in self-pay medical markets / Jim Hawkins -- Extrinsic incentives, intrinsic motivation, and motivational crowding-out in health law and policy / Kristin Underhill -- Do financial incentives reduce intrinsic motivation for weight loss? : evidence from two tests of crowding-out / Aditi P. Sen, David Huffman, George Loewenstein, David A. Asch, Jeffrey T. Kullgren, and Kevin G. Volpp -- Affective forecasting in medical decision-making : what do physicians owe their patients? / Jennifer L. Zamzow -- Behavioral economics in the physician-patient relationship : a possible role for mobile devices and small data / Alexander M. Capron and Donna Spruijt-Metz -- The perilous promise of privacy : ironic influences on disclosure of health information / Ester Moher and Khaled El Emam -- Procedural justice by default : addressing medicare's backlog crisis / Matthew J.B. Lawrence -- Measuring the welfare effects of a nudge : a different approach to evaluating the individual mandate / Manisha Padi and Abigail R. Moncrieff -- Better off dead-paternalism and persistent unconsciousness / Sarah Conly -- Improving healthcare decisions through a shared preferences and values approach to surrogate selection / Nina A. Kohn -- Consumer protection in genome sequencing / Barbara J. Evans -- Forced to choose again : the effects of defaults on individuals in terminated health plans / Anna D. Sinaiko and Richard J. Zeckhauser -- Presumed consent to organ donation / David Orentlicher

I. Glenn Cohen

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