Working with DSP

(main phone) 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:  Routing forms are in UIRIS research-information-system-uiris  Confidentiality Agreements (CDAs) Non-Monetary Routing Form  Clinical Trial Agreements (CTAs) 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: controls-home For questions or concerns Pat Cone-Fisher ( ) Loren LeClair ( ) Export Control Coordinator Division of Sponsored Programs or

or University of Iowa Division of Sponsored Programs 2 Gilmore Hall