1. Application Routing, Submission and Related Processes Don C. Saha, PhD Director, ORSP Department of Research Administration and Finance

2. Grant Application Process Internal Process – Routing of an application External process – review and notification

3. Application Routing Process Identify your Project Officer at ORSP Speak to your Project Officer Start working on the application – Budget (checklist, face page, sponsor’s F&A rate documentation – Routing Form – Research Proposal

4. Project Officers Vacant, Assistant Director Debbie Gaudreau, ext. 2434 Paul Hudobenko, ext. 3951 ORSP Main Number - 4040

5. Application Routing Fill out the Routing Form Attach necessary documentations – Non-federal, guidelines including the F&A rate information – If no F&A costs allowed, provide documentation If salary support is less than the % effort, written approval is required from the Associate Dean for Finance (SOM), Associate Dean for Research (SODM).

6. Application Routing (Contd…) Sign (PI) the Application and the Routing Form Get all signatures – Co-Principal Investigators or Co-investigators – Department Head/Division Chief – Dean or Associate/Assistant Deans – Associate Dean for Finance/Associate Dean for Research

7. Application Process (Contd…) If it involves human subjects, contact the IRB Office (D. Gibb, ext. 3054) If it involves animal, contact the ACC (A. Pohl, ext. 4129) If it involves infectious agents, carcinogenic substances, rDNA or HIV, contact the Biological Safety Officer, Ron Wallace, PhD at ext. 3781 If it involves radiation and other chemical hazards, contact the Office of Research Safety at ext. 2250

8. Human Subjects Just-in-time applications can be approved by the ORSP without IRB approval for submissions Clinical Trials Proposals will not be approved by the ORSP without IRB and Clinical Trials Office approvals Under no circumstances research can be conducted without IRB approval

9. Animal Research Proposals Just-in-time applications can be approved by the ORSP pending ACC approval for submissions Under no circumstances research can be conducted without ACC approval

10. Research Safety Chemical and other, Steve Jacobs, ext 2723 Radiation Safety – Hospital, Andres Sinisterra ext. 2250 Radiation Safety – Research, Jim Fomenko ext. 2250 Biological Safety, Ron Wallace, PhD, CIH, ext. 3781 or 2723 Select Agents – Combined list, 83 agents or substances

11. Select Agents What is the agent? Whether it exceeds the threshold limit? If it does – Know if we are approved – Know who will be involved Foreign students or workers from the following countries are not allowed to work on such projects: Cuba, Iran, Libya, North Korea, Sudan, and Syria

12. Export Control Administered under Export Administration Regulations (EAR) by the Bureau of Industry Security (BIS) arm of the Department of Commerce Materials or data that have potential military use received or sent to certain individuals or countries Also, materials that can be used in terrorist activities

13. Material Transfer Agreements Incoming MTAs – Financial – Intellectual property rights – Data ownerships and publication rights – Governing Law – Liability and Indemnity Outgoing MTAs ( Center for Science & Technology Commercialization ) – Export Control – Intellectual property rights

14. Agreements and Contracts Research Contracts or Sub-contracts – ORSP Income Generating Contracts – Martin Powell, 2284 Clinical Trials – Office of Clinical and Translational Research. For Agreement - Judy Gilson, ext. 2742; for budget, Judi Kulko - ext. 1395 Personal Service Agreements – Debby Anderson 1616

15. Clinical Trials Use Clinical Trials Routing Form Clinical Trials – Judy Gilson, ext. 2742; for budget, Judith Kulko, ext. 1395 NIH-supported Clinical Trials – special requirements

16. Application Process (Contd…) Bring the completed application with the signed Routing Sheet to ORSP – Either hand it to the Executive Assistant or leave it on the basket marked “Application” – Please do not forget to date stamp it We will call you when it is ready or need additional documentation or clarification