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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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What Is This Thing Called Research?

What Is This Thing Called Research?

(p.285) 18 What Is This Thing Called Research?
Human Subjects Research Regulation

Zachary M. Schrag

The MIT Press

This chapter explores various ways of distinguishing research that should and should not be covered by human subjects regulations. Aligning regulations to the underlying statute, which only covers “biomedical and behavioral research,” would return scrutiny to the areas of concern identified by Congress. Alternatively, defining “human subjects” more narrowly as those people in the power of an investigator might focus energy on the prevention of the abuse of power. By contrast, relying on distinctions between generalizable knowledge and nongeneralizable knowledge is the very worst strategy, for in three decades policy makers have proved unable to agree on what this distinction means.

Keywords:   Biomedical research, Behavioral research, Social Science, Human Subjects, Generalizability, Regulations

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