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This chapter provides an overview of recent diabetes prediction and prediction/prevention studies beyond the newborn period. It examines whether these studies are permissible under current federal regulations, and whether proposed modifications improve human subject protections. In the process, it is clarified whether and when children ‘at risk’ for ‘a disorder or condition’ should qualify for having ‘a disorder or condition’.

The chapter begins with Paul Ramsey's argument which offers the most prominent and persuasive argument against nonbeneficial pediatric research. Ramsey argues that nonbeneficial pediatric research is necessarily unethical because it involves exploitation, exposing those who cannot consent to risks for the benefit of others. To evaluate this argument it is necessary to consider the importance of informed consent, when is it necessary and why. The chapter then considers a number of prominent views which hold, effectively, that we do not need a justification for nonbeneficial pediatric research because such research does not raise serious ethical concern in the first place. Commentators offer a number of arguments for this view, citing the fact that the risks of most nonbeneficial pediatric research studies are low or children would consent to it if they could consent.

This chapter discusses the history of human experimentation, with special attention to cases that have helped to shape ethical guidelines and policies. It discusses important codes, such as the Nuremberg Code and the Declaration of Helsinki, and it provides an overview of U.S. federal regulations. The chapter also addresses some key concepts and principles in human research, such as informed consent, risk/benefit ratios, minimal risk, and research versus therapy.

The Department of Health and Human Services’ 2011 ANPRM is a step in the process of revising the federal regulations governing human research. Several sections of the ANPRM focus on measuring and minimizing research risks and calibrating the scope of oversight to studies’ risk levels. This chapter focuses on one risk-related proposal, the proposal to eliminate continuing review of minimal risk research that has undergone expedited review. It examines the goals of the ANPRM, defends a particular interpretation of those goals, and assesses the proposal to eliminate continuing review of previously expedited minimal risk protocols in light of those goals. For this proposal to be consistent with the ANPRM’s goals and the goals of human research regulation more generally, three false assumptions would have to be true. The proposal should be abandoned. Instead, current oversight procedures should be made more efficient.