18 found
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  1. Expanding the Frame of "Voluntariness" in Informed Consent: Structural Coercion and the Power of Social and Economic Context.Jill A. Fisher - 2013 - Kennedy Institute of Ethics Journal 23 (4):355-379.
    Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher has the (...)
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  2.  50
    Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research.Rebecca L. Walker, Marci D. Cottingham & Jill A. Fisher - 2018 - Journal of Medicine and Philosophy 43 (1):83-114.
    Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...)
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  3.  20
    Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.Jill A. Fisher - 2015 - Science, Technology, and Human Values 40 (2):199-226.
    Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...)
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  4.  37
    To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials.Lisa McManus & Jill A. Fisher - 2018 - AJOB Empirical Bioethics 9 (2):82-90.
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  5.  17
    Mission Creep or Mission Lapse? Scientific Review in Research Oversight.Margaret Waltz, Jill A. Fisher & Rebecca L. Walker - 2023 - AJOB Empirical Bioethics 14 (1):38-49.
    Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...)
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  6.  30
    Research Payment and Its Social Justice Concerns.Jill A. Fisher - 2019 - American Journal of Bioethics 19 (9):35-36.
    Volume 19, Issue 9, September 2019, Page 35-36.
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  7.  67
    Procedural misconceptions and informed consent: Insights from empirical research on the clinical trials industry.Jill A. Fisher - 2006 - Kennedy Institute of Ethics Journal 16 (3):251-268.
    : This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...)
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  8.  29
    Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.Lisa McManus, Arlene Davis, Rebecca L. Forcier & Jill A. Fisher - 2019 - Journal of Law, Medicine and Ethics 47 (2):323-333.
    While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...)
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  9.  30
    Institutional mistrust in the organization of pharmaceutical clinical trials.Jill A. Fisher - 2008 - Medicine, Health Care and Philosophy 11 (4):403-413.
    In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians (...)
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  10.  30
    Introduction.Raymond de Vries & Jill A. Fisher - 2013 - Cambridge Quarterly of Healthcare Ethics 22 (4):389-390.
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  11.  25
    "My Body is One of the Best Commodities": Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials.Rebecca L. Walker & Jill A. Fisher - 2019 - Kennedy Institute of Ethics Journal 29 (4):305-331.
    In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...)
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  12.  20
    Global Efforts to Protect Healthy Volunteers.Jill A. Fisher - 2023 - Hastings Center Report 53 (4):2-2.
    Clinical trials on healthy volunteers generate unique ethical challenges both because participants accept potential physical risks without the possibility of direct medical benefit and because participants’ financial motivations to enroll in trials could lead to their exploitation. Despite the large volume of published empirical studies and ethical analyses of healthy volunteer research, there has been little concerted effort to change how healthy‐volunteer research is overseen or regulated. A new collaborative effort to do so is the VolREthics (Volunteers in Research and (...)
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  13.  96
    Tattooing the Body, Marking Culture.Jill A. Fisher - 2002 - Body and Society 8 (4):91-107.
    This article examines the complex relationship between power and the physical and social practices of tattooing in contemporary United States. Briefly tracing the history of tattooing from ancient Greece to contemporary America, I highlight the temporal and geographical changes in the practices and perceptions of tattooing. In addition to creating a historical narrative, I situate the sociocultural practice of tattooing the body for the tattooist and the `tattooee'. This investigation into body inscription serves as a means to elucidate the contemporary (...)
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  14.  12
    “Death and Taxes”: Why Financial Compensation for Research Participants is an Economic and Legal Risk.Margaret Waltz, Arlene M. Davis & Jill A. Fisher - 2023 - Journal of Law, Medicine and Ethics 51 (2):413-425.
    In the US, research payments are technically taxable income. This article argues that tax liability is a form of possible economic and legal risk of paid research participation. Findings are presented from empirical research on Phase I healthy volunteer trials. The article concludes by discussing the implications of these findings for the informed consent process, as well as for broader ethical issues in whether and how payments for research participation should be regulated.
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  15.  24
    Correction to: Picking and Choosing Among Phase I Trials.Jill A. Fisher, Torin Monahan & Rebecca L. Walker - 2020 - Journal of Bioethical Inquiry 18 (1):193-193.
    The article "Picking and Choosing Among Phase I Trials", written by Jill A. Fisher, Torin Monahan and Rebecca L. Walker, was originally published Online First without Open Access. After publication in volume 16, issue 4, page 535-549 the author decided to opt for Open Choice and to make the article an Open Access publication.
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  16.  43
    Companion Animal Studies: Slipping Through a Research Oversight Gap.Rebecca L. Walker & Jill A. Fisher - 2018 - American Journal of Bioethics 18 (10):62-63.
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  17.  51
    Playing Patient, Playing Doctor: Munchausen Syndrome, Clinical S/M, and Ruptures of Medical Power. [REVIEW]Jill A. Fisher - 2006 - Journal of Medical Humanities 27 (3):135-149.
    This article deploys sadomasochism as a framework for understanding medical practice on an institutional level. By examining the case of the factitious illness Munchausen syndrome, this article analyzes the operations of power in the doctor-patient relationship through the trope of role-playing. Because Munchausen syndrome causes a disruption to the dyadic relationship between physicians and patients, a lens of sadomasochism highlights dynamics of power in medical practice that are often obscured in everyday practice. Specifically, this article illustrates how classification and diagnosis (...)
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  18.  16
    Review of Donald W. Light and Antonio F. Maturo, Good Pharma: The Public-Health Model of the Mario Negri Institute1. [REVIEW]Jill A. Fisher - 2017 - American Journal of Bioethics 17 (2):W9 - W10.
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