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  1. When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?Stephanie R. Morain, Steven Joffe & Emily A. Largent - 2019 - American Journal of Bioethics 19 (4):11-18.
    Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...)
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  • Litigation in Clinical Research: Malpractice Doctrines versus Research Realities.E. Haavi Morreim - 2004 - Journal of Law, Medicine and Ethics 32 (3):474-484.
    Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...)
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  • The truth about the truth: What matters when privacy and anonymity can no longer be promised to those who participate in clinical trial research?Ann Freeman Cook & Helena Hoas - 2013 - Research Ethics 9 (3):97-108.
    The ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 states across (...)
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  • The Law of Mass Action.Howard Trachtman - 2006 - American Journal of Bioethics 6 (4):72-74.
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  • Innovation in Human Research Protection: The AbioCor Artificial Heart Trial.E. Haavi Morreim, George E. Webb, Harvey L. Gordon, Baruch Brody, David Casarett, Ken Rosenfeld, James Sabin, John D. Lantos, Barry Morenz, Robert Krouse & Stan Goodman - 2006 - American Journal of Bioethics 6 (5):W6-W16.
    Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...
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  • Role-Differentiated Morality: The Need to Consider Institutions, Not Just Individuals.Ronald A. Lindsay - 2006 - American Journal of Bioethics 6 (4):70-72.
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  • 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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  • Exploring the Potential for Moral Hazard When Clinical Trial Research is Conducted in Rural Communities: Do Traditional Ethics Concepts Apply?Ann Freeman Cook & Helena Hoas - 2015 - HEC Forum 27 (2):171-187.
    Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who conducted clinical trials with (...)
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  • Clinicians or Researchers, Patients or Participants: Exploring Human Subject Protection When Clinical Research Is Conducted in Non-academic Settings.Ann Freeman Cook & Helena Hoas - 2014 - AJOB Empirical Bioethics 5 (1):3-11.
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