Document Detail


The convergence of research and clinical practice: institutional review board review of humanitarian use device applications.
MedLine Citation:
PMID:  19385757     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Elisa J Gordon; Sean Philpott
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of empirical research on human research ethics : JERHRE     Volume:  3     ISSN:  1556-2646     ISO Abbreviation:  J Empir Res Hum Res Ethics     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2009-04-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101273949     Medline TA:  J Empir Res Hum Res Ethics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  81-98     Citation Subset:  -    
Affiliation:
Northwestern University.
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