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At least 1,495 records · Page 83Linked to original sources
PubMed2004

Risk standards for pediatric research: rethinking the Grimes ruling.

In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well.

Baltimore↗
PubMed2005

Bioethics as politics: the limits of moral expertise.

The increasing reliance upon, and perhaps the growing public and professional skepticism about, the special expertise of bioethicists suggests the need to consider the limits of moral expertise. For all the talk about method in bioethics, we, bioethicists, are still rather far off the mark in understanding what we are doing, even when we may be going about what we are doing fairly well. Quite often, what is most fundamentally at stake, but equally often insufficiently acknowledged, are inherently political, essentially contested visions of the most compelling and attractive forms of life for individuals and social organization. The current situation in bioethics parallels similar debates in eighteenth-century jurisprudence, especially Jeremy Bentham's withering critique of the prevalent forms of judicial argument and his own, equally unsuccessful, attempt to develop a decision-making procedure in ethics that would operate on a plane above politics. The risk, both then and now, is that we will fail to appreciate the wide range of reasonable disagreement that will remain past the point of extended reflection and discussion.

Advisory Committees↗
PubMed1988

Gray v. Romeo.

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Attitude↗