7 found
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  1.  45
    Moral Gridlock: Conceptual Barriers to No‐Fault Compensation for Injured Research Subjects.Leslie Meltzer Henry - 2013 - Journal of Law, Medicine and Ethics 41 (2):411-423.
    The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...)
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  2.  25
    Respect and Dignity: A Conceptual Model for Patients in the Intensive Care Unit.Leslie Meltzer Henry, Cynda Rushton, Mary Catherine Beach & Ruth Faden - 2015 - Narrative Inquiry in Bioethics 5 (1A):5A-14A.
  3.  8
    Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects.Leslie Meltzer Henry - 2013 - Journal of Law, Medicine and Ethics 41 (2):411-423.
    The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on (...)
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  4.  50
    Revising the Common Rule: Prospects and Challenges.Leslie Meltzer Henry - 2013 - Journal of Law, Medicine and Ethics 41 (2):386-389.
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  5.  37
    Research with Pregnant Women: New Insights on Legal Decision‐Making.Anna C. Mastroianni, Leslie Meltzer Henry, David Robinson, Theodore Bailey, Ruth R. Faden, Margaret O. Little & Anne Drapkin Lyerly - 2017 - Hastings Center Report 47 (3):38-45.
    U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. (...)
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  6.  23
    Deciphering Dignity.Leslie Meltzer Henry - 2010 - American Journal of Bioethics 10 (7):59-61.
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  7.  26
    What is Fair Participant Selection?Leslie Meltzer Henry & James Childress - unknown
    The U.S. regulations for the protection of humans in biomedical and behavioral research were "born in scandal and reared in protectionism." This paper discusses the evolution of these regulations and the gaps that still persist in the ongoing effort to strike a balance between protecting vulnerable populations from research risks and providing all individuals and groups with an equal opportunity to benefit from research. In particular, this paper focuses on racial, social, and economic inequities in the selection of research participants; (...)
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