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  1. Clinical Research in Context: Reexamining the Distinction between Research and Practice.J. A. Anderson - 2010 - Journal of Medicine and Philosophy 35 (1):46-63.
    At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry by identifying crucial contextual constraints on (...)
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  • The Clinical Investigator as Fiduciary: Discarding a Misguided Idea.E. Haavi Morreim - 2005 - Journal of Law, Medicine and Ethics 33 (3):586-598.
    One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...)
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  • Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research.David Orentlicher - 2005 - Hastings Center Report 35 (5):20.
    When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective. Making treatment conditional on research participation will help researchers complete badly needed studies.
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  • Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...)
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  • Doctor vs. scientist?Lynn A. Jansen - 2008 - Hastings Center Report 38 (2):3-3.
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  • Avoiding a jekyll-and-Hyde approach to the ethics of clinical research and practice.Trudo Lemmens & Paul B. Miller - 2002 - American Journal of Bioethics 2 (2):14 – 17.
    (2002). Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice. The American Journal of Bioethics: Vol. 2, No. 2, pp. 14-17.
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  • Phase IV research: innovation in need of ethics.G. J. M. W. van Thiel & J. J. M. van Delden - 2008 - Journal of Medical Ethics 34 (6):415-416.
    Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to protect (...)
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  • Clinical ethics versus clinical research.Paul S. Appelbaum & Charles W. Lidz - 2006 - American Journal of Bioethics 6 (4):53 – 55.
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