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Papers on the Clinical Trials Industry

 

 

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2006 “Co-ordinating ‘Ethical’ Clinical Trials: The Role of Research Coordinators in the Contract Research Industry.” Sociology of Health and Illness 28 (6): 678-394.
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2006 “Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry.” Kennedy Institute of Ethics Journal 16 (3): 251-268.
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2007 “Governing Human Subjects Research in the USA: Individualized Ethics and Structural Inequalities.” Science & Public Policy 34 (2): 117-126.
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2007 “Coming Soon to a Physician Near You: Medical Neoliberalism and Pharmaceutical Clinical Trials.” Harvard Health Policy Review 8 (1): 61-70.
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2007 “'Ready-to-Recruit' or 'Ready-to-Consent' Populations?: Informed Consent and the Limits of Subject Autonomy.” Qualitative Inquiry 13 (6): 875-894.
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2008 “Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials.” Social Science & Medicine 66 (12): 2495-2505.
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2008 “Institutional Mistrust in the Organization of Pharmaceutical Clinical Trials.” Medicine, Health Care, & Philosophy 11 (4): 403-413.
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2008 “Direct-to-Consumer Responsibility: Medical Neoliberalism in Pharmaceutical Advertising and Drug Development.” (with Lorna M. Ronald). In S.M. Chambre & M. Goldner (Eds.), Patients, Consumers, and Civil Society (Advances in Medical Sociology, Volume 10) (pp. 29-51). Brighton, UK: Emerald Publishing.
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2010 “Re-inscribing Gender within New Modes of Medical Expertise: The Investigator-Coordinator Relationship in the Clinical Trials Industry.” Gender, Work & Organization 17 (2): 150-173.
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2010 “Sex, Gender, and Pharmaceutical Politics: From Drug Development to Marketing” (with Lorna M. Ronald). Gender Medicine 7 (4): 357-370.
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2012 “United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study” (with Corey A. Kalbaugh). PLoS Medicine 9 (7): e1001271.
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2012 Altruism in Clinical Research: Coordinators’ Orientation to their Professional Roles (with Corey A. Kalbaugh). Nursing Outlook 60 (3): 143-148.

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2013 Expanding the Frame of ‘Voluntariness’ in Informed Consent: Structural Coercion and the Power of Social and Economic Context. Kennedy Institute of Ethics Journal 23 (4): 355-379.

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2014 “Tracking the Pharmaceutical Pipeline: Clinical Trials and Global Disease Burden” (with Marci D. Cottingham & Corey A. Kalbaugh). Clinical and Translational Science 7 (4): 297-299.

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2015 “Peering into the Pharmaceutical ‘Pipeline’: Investigational Drugs, Clinical Trials, and Industry Priorities” (with Marci D. Cottingham & Corey A. Kalbaugh). Social Science & Medicine 131: 322-330.

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2019 Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework.” (with Rebecca L. Walker). Ethics & Human Research 41 (1): 4-14.

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2019 “Research Payment and Its Social Justice Concerns.” American Journal of Bioethics 19 (9): 35-36.

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2022
Ethical Criteria for Improved Human Subject Protections in Phase I Healthy Volunteer Trials” (with Rebecca L. Walker, Douglas MacKay, Margaret Waltz, & Anne D. Lyerly). Ethics & Human Research 44 (5): 2-21.

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2023 “Exclusion of Women from Phase I Trials: Perspectives from Investigators and Research Oversight Officials”(with Margaret Waltz & Anne D. Lyerly). Ethics & Human Research 45 (6): 19-30.

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2024. “Healthy Volunteers.” In D. MacKay & A. Iltis (Eds.)., Oxford Handbook of Research Ethics (pp. 769-784). New York: Oxford University Press.

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