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Division of Sponsored Programs

Division of Sponsored Programs. Working with DSP. DSP Contract Negotiators. 335-2123 (main phone) dsp-contracts@uiowa.edu Wendy Beaver Diana Boeglin Jessica Boyle Erin Brothers Pat Cone-Fisher Caite Flaherty Kathie Gonzales Linda Jones Loren LeClair Angi Roemerman

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Division of Sponsored Programs

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  1. Division of Sponsored Programs Working with DSP

  2. DSP Contract Negotiators 335-2123 (main phone) dsp-contracts@uiowa.edu Wendy Beaver Diana Boeglin Jessica Boyle Erin Brothers Pat Cone-Fisher Caite Flaherty Kathie Gonzales Linda Jones Loren LeClair Angi Roemerman Ryan Ross

  3. Starting a CDA or CTA • “How to” information: http://dsp.research.uiowa.edu/how • Routing forms are in UIRIS http://dsp.research.uiowa.edu/university-iowa-research-information-system-uiris • Confidentiality Agreements (CDAs) Non-Monetary Routing Form • Clinical Trial Agreements (CTAs) UI Proposal Routing Form

  4. What to Route - CDAs • 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

  5. What to Route - CTAs • 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

  6. CTA Process Overview • 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)

  7. Budgets • 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

  8. CTA Process Overview • 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

  9. CTA Process Overview • Requirements for Release of Contract and IRB Approval: • Fully signed contract AND • IRB approval for the study • AAAN is issued/MFK is assigned

  10. CTA Negotiating Points • 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.

  11. CTA Negotiating Points • 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

  12. Export Controls • 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

  13. Export Controls 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

  14. Export Controls 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

  15. Export Controls For additional information: http://dsp.research.uiowa.edu/export-controls-home For questions or concerns Pat Cone-Fisher (335-3582) Loren LeClair (335-2120) Export Control Coordinator Division of Sponsored Programs Patricia-cone-fisher@uiowa.edu, Loren-LeClair@uiowa.edu or Export-control@uiowa.edu

  16. Contact DSP 335-2123 or dsp-contracts@uiowa.edu University of Iowa Division of Sponsored Programs 2 Gilmore Hall

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