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Do you really know what you are in for when you sign a routing form?University of ColoradoDenver | Anschutz Medical CampusBrown Bag Panel PresentationThursday, June 23, 2011
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Internally, the three “I’s” govern the approval process for most research activities
• IACUC• IRB• IBC• And also the
Radiation Safety Committee
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A vast array of regulatory
entities underpin the approvals in boxes 5, 6, 7, and 8a & 8bDOD, NIH,
CDC, and/or USDAAAALAC,
DOD, HHS, NIH, CDC,
and/or USDA
HHS, NIH, DEA, and
FDA
DOD, NRC, DOE, FBI and
State Regulators
DOD, HHS, NIH, CDC, FBI and/or
USDA
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Take-Aways
1. You do not need to be the subject matter expert in all of these areas.
2. Get to know your EHS staff and committee members
3. Committee approval could take several months – do Just-In-Time processes apply?
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When this box is checked on the routing form, there’s a lot that goes on behind the scenes down the hall from the Offices of Grants and Contracts at UC Denver – the Who, What, Where and When of COI!
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Postaward Certifications:
Effort Certified Over- Commitment
Direct Expenses Scope of Work Allocation University Policy
Cost Share Commitment
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Do you really know what it means to commit cost share?
How will you use the budget?
So you are going to be conducting a trial? Tell us about it!
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Electronic Routing Process
PI/Administrator Authors Proposal
PI Approval
Department Chair Review/Approval
Dean of School/College Review/Approval
Grants & Contracts Review
• Steps inserted when required
• Rejections sent back to PI and/or Administrator for correction
• If updated, routing restarts with PI
• Grants & Contracts return proposal with no further routing required, regardless of updates needed