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

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

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

Project Officers Vacant, Assistant Director Debbie Gaudreau, ext Paul Hudobenko, ext ORSP Main Number

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).

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

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 If it involves radiation and other chemical hazards, contact the Office of Research Safety at ext. 2250

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

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

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

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

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

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

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 Personal Service Agreements – Debby Anderson 1616

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

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