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  1. The limitations of "vulnerability" as a protection for human research participants.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):44 – 49.
    Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...)
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  • Pediatric Research Regulations Under Legal Scrutiny: Grimes Narrows Their Interpretation.Loretta M. Kopelman - 2002 - Journal of Law, Medicine and Ethics 30 (1):38-49.
    In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...)
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  • Pediatric Research Regulations under Legal Scrutiny: Grimes Narrows Their Interpretation.Loretta M. Kopelman - 2002 - Journal of Law, Medicine and Ethics 30 (1):38-49.
    In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...)
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  • Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
    Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...)
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