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  1. Exploitation and International Clinical Research: The Disconnect Between Goals and Policy.Danielle M. Wenner - 2018 - In David Boonin (ed.), Palgrave Handbook of Philosophy and Public Policy. Cham: Palgrave Macmillan. pp. 563-574.
    A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...)
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  • Barriers to Effective Deliberation in Clinical Research Oversight.Danielle M. Wenner - 2016 - HEC Forum 28 (3):245-259.
    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value (...)
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  • What the ANPRM Missed: Additional Needs for IRB Reform.Charles W. Lidz & Suzanne Garverich - 2013 - Journal of Law, Medicine and Ethics 41 (2):390-396.
    Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.
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  • What the ANPRM Missed: Additional Needs for IRB Reform.Charles W. Lidz & Suzanne Garverich - 2013 - Journal of Law, Medicine and Ethics 41 (2):390-396.
    The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of (...)
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