Zachary M. Schrag
- Published in print:
- 2014
- Published Online:
- January 2015
- ISBN:
- 9780262027465
- eISBN:
- 9780262320825
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262027465.003.0024
- Subject:
- Biology, Bioethics
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 ...
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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.Less
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.
