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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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De minimis Risk: A Suggestion for a New Category of Research Risk

De minimis Risk: A Suggestion for a New Category of Research Risk

(p.31) 2 De minimis Risk: A Suggestion for a New Category of Research Risk
Human Subjects Research Regulation

Rosamond Rhodes

The MIT Press

This chapter argues for establishing de minimis risk as a new sub-category of research risk. It regards informed consent as an important consideration in human subject research, but not an absolute requirement. Instead it urges a more nuanced and contextual approach to determining when informed consent must be obtained. The level of risks and harms involved in participation, as well as the burdens, costs and feasibility of providing the information all have to be considered. For some studies, robust informed consent from the participant should be the standard. For others, such as biobank research, agreement based on less than full information will be adequate. And in some circumstances, such as registry and public health research, no consent is required at all. This proposal puts the focus of research ethics where it belongs, on an assessment of risks and benefits, and reduces unreasonable obstacles that have inhibited research. Allowing studies to proceed under the category of de minimis risk would strike a reasonable balance between advancing biomedical science and societal health, and the importance of respecting persons.

Keywords:   informed consent, biobanks, registry, public health, risk, benefit, respect

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