Application Routing, Submission Application Routing, Submission and Related Processesand Related Processes

Don C. Saha, PhDDirector, ORSP

Department of Research Administration and Finance

Grant Application ProcessGrant Application Process

Internal Process – Routing of an applicationExternal process – review and notification

Application Routing ProcessApplication Routing Process

Identify your Project Officer at ORSPSpeak to your Project OfficerStart working on the application

– Budget (checklist, face page, sponsor’s F&A rate documentation

– Routing Form– Research Proposal

Project OfficersProject Officers

• Vacant, Assistant Director• Debbie Gaudreau, ext. 2434• Paul Hudobenko, ext. 3951

ORSP Main Number - 4040

Application RoutingApplication 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…)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…)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

Human SubjectsHuman 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 ProposalsAnimal 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 SafetyResearch 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

Select AgentsSelect 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 ControlExport 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 AgreementsMaterial 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 ContractsAgreements 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

Clinical TrialsClinical Trials

Use Clinical Trials Routing Form Clinical Trials – Judy Gilson, ext. 2742; for

budget, Judith Kulko, ext. 1395 NIH-supported Clinical Trials – special

requirements

Application Process (Contd…)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