•  110
    Studying benefit in gene transfer research
    with Gail E. Henderson
    IRB: Ethics & Human Research. forthcoming.
  •  59
  •  49
    Protection of human subjects and scientific progress: Can the two be reconciled?
    with Kathleen Cranley Glass, David B. Resnik, Stephen Olufemi Sodeke, Halley S. Faust, Rebecca Dresser, C. D. Herrera, David Orentlicher, and Lynn A. Jansen
    Hastings Center Report 36 (1): 4-9. 2006.
  •  48
    Athlete or Guinea Pig? Sports and Enhancement Research
    with Richard Robeson
    Studies in Ethics, Law, and Technology 1 (1). 2007.
  •  46
    Loss of Possession: Concussions, Informed Consent, and Autonomy
    with Richard Robeson
    Journal of Law, Medicine and Ethics 42 (3): 334-343. 2014.
    The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implem…Read more
  •  36
    Biodefense Research and the U.S. Regulatory Structure Whither Nonhuman Primate Moral Standing?
    with Rebecca L. Walker
    Kennedy Institute of Ethics Journal 21 (3): 277-310. 2011.
    Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and …Read more
  •  36
    Bad Blood Thirty Years Later: A Q&A with James H. Jones
    with James H. Jones
    Journal of Law, Medicine and Ethics 40 (4): 867-872. 2012.
    Historian James H. Jones published the first edition of Bad Blood, the definitive history of the Tuskegee Syphilis Experiment, in 1981. Its clear-eyed examination of that research and its implications remains a bioethics classic, and the 30-year anniversary of its publication served as the impetus for the reexamination of research ethics that this symposium presents. Recent revelations about the United States Public Health Service study that infected mental patients and prisoners in Guatemala wi…Read more
  •  35
    Vulnerability to influence: A two-way street
    with Gail E. Henderson and Arlene M. Davis
    American Journal of Bioethics 4 (3). 2004.
    This Article does not have an abstract
  •  32
    What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011
    with Gail E. Henderson, Eric T. Juengst, Kristine Kuczynski, and Marsha Michie
    Journal of Law, Medicine and Ethics 40 (4): 1008-1024. 2012.
    In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of …Read more
  •  25
    RAC Oversight of Gene Transfer Research: A Model Worth Extending?
    Journal of Law, Medicine and Ethics 30 (3): 381-389. 2002.
    Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.C…Read more
  •  24
    Conscience, Courage, and “Consent”
    with Mark A. Hall
    Hastings Center Report 46 (2): 30-32. 2016.
    On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates …Read more
  •  22
    An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial
    with Robert M. Nelson and Ken Kipnis
    American Journal of Bioethics 10 (10): 5-8. 2010.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme?, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme? and saline in the field and, still without consent, randomized between PolyHeme? and blood after arrival at an eme…Read more
  •  22
    Nanomedicine First-in-Human Research: Challenges for Informed Consent
    Journal of Law, Medicine and Ethics 40 (4): 823-830. 2012.
    First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also consi…Read more
  •  22
    There's A Lot We Don't Know (and We Ought to Say So)
    American Journal of Bioethics 13 (12): 20-21. 2013.
    No abstract
  •  20
    Who's Winning the IRB Wars? The Struggle for the Soul of Human Research
    Perspectives in Biology and Medicine 61 (3): 450-464. 2018.
    One of my favorite bioethics quotes is nearing 50 years old:Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be threatened by the erosion of th…Read more
  •  19
    Defining and Describing Benefit Appropriately in Clinical Trials
    Journal of Law, Medicine and Ethics 28 (4): 332-343. 2000.
    Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fra…Read more
  •  18
    The ethics committee as greek chorus
    HEC Forum 8 (6): 346-354. 1996.
  •  18
    Shaping Our Selves: On Technology, Flourishing, and a Habit of Thinking by Erik Parens
    Kennedy Institute of Ethics Journal 26 (1): 5-10. 2016.
    In Shaping Our Selves, Erik Parens offers both a personal history of bioethics and a cleverly clarifying lens to train on disputes in bioethics about emerging technologies. The question for readers is whether this lens, as useful as it is, leaves too much outside our field of vision. Parens, born in 1957, comes from the first wave of bioethics scholars—those of us who still mostly happened into bioethics as a field, before it was sufficiently well-established to be identified as a career pathway…Read more
  •  16
    Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
    with Joseph E. Andrews, J. Brian Moore, Richard B. Weinberg, Mysha Sissine, Sabina Gesell, Jacquie Halladay, Wayne Rosamond, Cheryl Bushnell, Sara Jones, Paula Means, Diana Omoyeni, and Pamela W. Duncan
    Journal of Medical Ethics 44 (8): 560-566. 2018.
    Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the fea…Read more
  •  16
    An open letter to institutional review boards considering northfield laboratories' polyheme® trial
    with Ken Kipnis and Robert M. Nelson
    American Journal of Bioethics 6 (3). 2006.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an eme…Read more
  •  16
    Research Ethics: Reexamining Key Concerns
    Journal of Law, Medicine and Ethics 40 (4): 865-866. 2012.
  •  14
    Athletes Are Guinea Pigs
    with Richard Robeson
    American Journal of Bioethics 13 (10). 2013.
    No abstract
  •  14
    Transparency in Neonatal Intensive Care
    Hastings Center Report 22 (3): 18-25. 1992.
  •  12
    The Importance of Amicable and Productive Disagreement
    Journal of Medicine and Philosophy 40 (3): 286-288. 2015.
  •  11
    Genetic Research as Therapy: Implications of “Gene Therapy” for Informed Consent
    with Larry R. Churchill, Myra L. Collins, Stephen G. Pemberton, and Keith A. Wailoo
    Journal of Law, Medicine and Ethics 26 (1): 38-47. 1998.
    In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that …Read more
  •  11
    Experimental Treatment Oxymoron or Aspiration?
    Hastings Center Report 25 (4): 6-15. 1995.