Holly Fernandez Lynch

Holly Fernandez Lynch is Executive Director at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a member of the faculty at Harvard Medical School's Center for Bioethics.

  • Specimen Science

    Specimen Science

    Ethics and Policy Implications

    Holly Fernandez Lynch, Barbara E. Bierer, I. Glenn Cohen, and 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

    • Hardcover $45.00 £38.00
  • Human Subjects Research Regulation

    Human Subjects Research Regulation

    Perspectives on the Future

    I. Glenn Cohen and 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

    • Hardcover $66.00 £55.00
    • Paperback $35.00 £28.00
  • Conflicts of Conscience in Health Care

    Conflicts of Conscience in Health Care

    An Institutional Compromise

    Holly Fernandez Lynch

    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.

    • Hardcover $34.00 £28.00
    • Paperback $4.75 £3.99