Download Division of Sponsored Progrms - University of Iowa College of Public

Working with DSP
335-2123 (main phone)
[email protected]
Wendy Beaver
Diana Boeglin
Jessica Boyle
Erin Brothers
Pat Cone-Fisher
Caite Flaherty
Kathie Gonzales
Linda Jones
Loren LeClair
Angi Roemerman
Ryan Ross

“How to” information:
http://dsp.research.uiowa.edu/how
Routing forms are in UIRIS
http://dsp.research.uiowa.edu/university-iowaresearch-information-system-uiris


Confidentiality Agreements (CDAs)

Clinical Trial Agreements (CTAs)
Non-Monetary Routing Form
UI Proposal Routing Form
CDAs
– Attach:
 CDA from the sponsor (Word version)
 Sponsor contact information and instructions
Helpful
Information:
 Related protocol or study title
 Link for click through CDAs
 Special instructions in comments section
CTAs




– Attach:
CTA from the sponsor (Word version)
Budget (even if it’s a draft)
Protocol
Sponsor contact information and instructions
Helpful
Information:
 Is protocol PI-initiated?
 Will there be a central IRB?
 Special instructions in comments section

Three Simultaneous Processes:

Contract Negotiation
(DSP negotiates with sponsor)

Budget Negotiation
(PI/Coordinator negotiate with sponsor)

IRB & Other Committee Approvals
(PI/Coordinator work with HSO/committees
and sponsor)

Direct Costs + 25% TDC F&A Costs = Total
◦ Include all costs (e.g., personnel, document
retention)
◦ Include non-refundable startup fees
◦ Present fully burdened budgets to industry
sponsors
 Requirements





for CTA Signature:
Agreement on contract terms (DSP lead)
Agreement on the budget (PI/Coordinator
lead)
If applicable:
Conflict of Interest in Research approval
Export Control review/approval

Requirements for Release of Contract and
IRB Approval:
Fully signed contract
AND
IRB approval for the study



AAAN is issued/MFK is assigned

AAHRPP Language
◦ New language
During and for a period of at least two years after the completion of
the study, Sponsor shall promptly report to the Investigator any
information that could directly affect the health or safety of past or
current study subjects or influence the conduct of the study, including
but not limited to the study results and information in site monitoring
reports and data safety monitoring committee reports as required by
the Protocol. In each case, the Investigator and the University shall
be free to communicate these findings to each study subject and the
IRB.

Subject Injury/Indemnification Coverage by
Sponsor
◦ UI Operations Manual II-27.1.d(2) requires
safeguards (indemnification) to protect the
University in corporate funded clinical trials
◦ Subject Injury/Indemnification Waiver Process

Export Controls are Federal laws which
regulate the export of certain items &
technology.
◦ Commerce Department (EAR) regulates the export
of items and technology which have both civil uses
and military applications
◦ State Department (ITAR) regulates the export of
items with inherently military uses
 Office of Foreign Assets Control (OFAC) lists restricted
parties
 Violations – can carry both criminal & civil sanctions
 Personal liability
Items which may be export controlled:
 Detection/protection equipment
 Biological agents and genetic elements
 Chemical agents and precursors
 Biological and Chemical processing equipment
 Lasers
 Software and Technology
If an item or technology is export controlled:
(1) Review what controls apply,
(2) Determine if Licenses are needed
(a) Physical export
(b) Deemed export
(3) If an Access Control Plan is needed
(a) Citizenship and location
If foreign Collaborators and Subcontractors:
Check Person, Entity and Country for
restrictions or sanctions precluding collaboration
For additional information:
http://dsp.research.uiowa.edu/exportcontrols-home
For questions or concerns
Pat Cone-Fisher (335-3582)
Loren LeClair (335-2120)
Export Control Coordinator
Division of Sponsored Programs
[email protected],
[email protected] or
[email protected]
335-2123
or
[email protected]
University of Iowa
Division of Sponsored Programs
2 Gilmore Hall