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The Convergence of Research and Clinical Practice: Institutional Review Board Review of Humanitarian Use Device Applications

Elisa J. Gordon and Sean Philpott
Journal of Empirical Research on Human Research Ethics: An International Journal
Vol. 3, No. 4 (December 2008), pp. 81-98
Published by: Sage Publications, Inc.
DOI: 10.1525/jer.2008.3.4.81
Stable URL: http://www.jstor.org/stable/10.1525/jer.2008.3.4.81
Page Count: 18
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The Convergence of Research and Clinical Practice: Institutional Review Board Review of Humanitarian Use Device Applications
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Abstract

WE SURVEYED IRB CHAIRS IN THE United States to ascertain whether their IRBs have clarity regarding their FDA-mandated role in reviewing humanitarian use device (HUD) applications, which are neither research devices nor fully tested treatments. Of 2,588 Chairs, 469 (18%) completed the survey, almost half of whom (44%) reported review of a HUD application within the previous five years. Findings suggest that many IRB Chairs are confused about what HUDs are, how to review HUD applications, and why IRBs should review them. We recommend that the FDA clarify their policies so that Chairs can provide the guidance necessary for IRBs to more effectively and consistently review HUD applications, and thereby better protect HUD-treated patients.

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