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.

A balanced proposal that protects both a patient's access to care and a physician's ability to refuse to provide certain services for reasons of conscience. Physicians in the United States who refuse to perform a variety of legally permissible medical services because of their own moral objections are often protected by “conscience clauses.” These laws, on the books in nearly every state since the legalization of abortion by Roe v. Wade, shield physicians and other health professionals from such potential consequences of refusal as liability and dismissal. While some praise conscience clauses as protecting important freedoms, opponents, concerned with patient access to care, argue that professional refusals should be tolerated only when they are based on valid medical grounds. In Conflicts of Conscience in Health Care, Holly Fernandez Lynch finds a way around the polarizing rhetoric associated with this issue by proposing a compromise that protects both a patient's access to care and a physician's ability to refuse. This focus on compromise is crucial, as new uses of medical technology expand the controversy beyond abortion and contraception to reach an increasing number of doctors and patients. Lynch argues that doctor-patient matching on the basis of personal moral values would eliminate, or at least minimize, many conflicts of conscience, and suggests that state licensing boards facilitate this goal. Licensing boards would be responsible for balancing the interests of doctors and patients by ensuring a sufficient number of willing physicians such that no physician's refusal leaves a patient entirely without access to desired medical services. This proposed solution, Lynch argues, accommodates patients' freedoms while leaving important room in the profession for individuals who find some of the capabilities of medical technology to be ethically objectionable.

An Institutional Compromise

Conflicts of Conscience in Health Care

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

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

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

Holly Fernandez Lynch

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