Kennedy Institute of Ethics journal
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Kennedy Inst Ethics J · Jun 2004
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 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.
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Kennedy Inst Ethics J · Jun 2004
Social contract theory and just decision making: lessons from genetic testing for the BRCA mutations.
Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection--e.g., patents--of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniel's and Sabin's "accountability for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation.