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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Risk Level, Research Oversight, and Decrements in Participant Protections

Risk Level, Research Oversight, and Decrements in Participant Protections

(p.45) 3 Risk Level, Research Oversight, and Decrements in Participant Protections
Human Subjects Research Regulation

Ana S. Iltis

The MIT Press

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.

Keywords:   expedited review, minimal risk, research oversight, research risk

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