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  1. Which Benefits Can Justify Risks in Research?Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden & on Behalf of the Trials@Home Consortium - forthcoming - American Journal of Bioethics:1-11.
    Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...)
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  • What we worry about when we worry about the ethics of clinical research.David Wendler - 2011 - Theoretical Medicine and Bioethics 32 (3):161-180.
    Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals (...)
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  • A framework for risk-benefit evaluations in biomedical research.Annette Rid & David Wendler - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • La Frontera: Responsibly Managing Borders and Boundaries in Clinical Ethics.L. B. Mccullough - 2010 - Journal of Medicine and Philosophy 35 (1):1-6.
    The papers in the 2010 “Clinical Ethics” number of the Journal of Medicine and Philosophy explore issues along La Frontera, the borders and boundaries of clinical ethics. The first three papers in this “Clinical Ethics” number of the Journal explore borders and boundaries drawn within clinical ethics, concerning the moral standing of complementary and alternative medicine, palliative sedation, and induced abortion and feticide. The fourth and fifth papers explore the borders and boundaries between research ethics and clinical ethics.
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  • Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.Neil C. Manson - 2017 - Journal of Medicine and Philosophy 42 (6):720-739.
    Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an “informational fallacy.” The aim in the second part of the paper is to provide a better approach to making sense of (...)
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