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Authors
Patorno, Elisabetta
Gagne, Joshua J.
Lu, Christine Y.
Haynes, Kevin
Sterrett, Andrew T.
Roy, Jason
Wang, Xingmei
Raebel, Marsha A.
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Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (HHSF22301012T-0008)
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Article History
First Online: 15 November 2016
Compliance with Ethical Standards
:
: The Mini-Sentinel program is funded by the US FDA through contract HHSF22301012T-0008 under Master Agreement HHSF223020091006I from the Department of Health and Human Services.
: The following authors received salary support from their institutions for this work conducted under contract HHSF22301012T-0008: Elisabetta Patorno, Josh J. Gagne, Christine Y. Lu, Kevin Haynes, Andrew T. Sterrett, Jason Roy, Xingmei Wang, and Marsha A. Raebel.
: The Health and Human Services Office of Human Research Protections determined that the Common Rule does not apply to activities included in the FDA’s Sentinel Initiative. This assessment also applies to Mini-Sentinel activities such as the work detailed in this paper, as Mini-Sentinel is part of the Sentinel Initiative. Because Mini-Sentinel activities are public health activities in support of FDA’s public health mission, they are not under the purview of institutional review boards or privacy boards.
