Application Routing, Submission and Related Processes

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, sponsors FA 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 FA rate
  information
• If no FA 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