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University of Louisville Policies & Procedures for Research and Other Sponsored Activities

CHAPTER ONE: General Information (07/15/2011)

Purpose
1.1 Definition of Sponsored Activities
Roles and Responsibilities for Research
Appendix A - Roles & Responsibilities Matrix

1.2 Offices of the Executive Vice President for Research
1.3 Office of Sponsored Programs Development
1.4 Office of Sponsored Programs Grants Administration (Grants Management)
1.5 Office of Industry Contracts
1.6 Office of Technology Transfer
1.7 Research Integrity Program
1.8 Human Subjects Protection Program
1.9 Principal Investigator/Project Director
1.10 Qualifications for Principal Investigator/Project Director Status
1.11 Unit Business Manager (or Designee)
1.12 Department Chair/Dean
1.13 Office of the Controller
1.14 Department of Audit Services

Compliance Committees
1.15 Executive Oversight Committee for Research Integrity
1.16 Research Integrity Committee

Task Forces
1.17 Human Subjects Task Force
1.18 Research Standards and Training Task Force
1.19 Conflict of Interest Task Force
1.20 Animal Welfare Task Force
1.21 Biological and Environmental Safety Task Force
1.22 Award Administration Task Force
1.23 Monitoring, Auditing and Response Task Force
1.24 HIPAA Research Task Force

CHAPTER TWO: Pre-Proposal Activities and Support (09/20/2012)

Finding Funding Opportunities
2.1 Search Process & Resources
2.2 Faculty Interest Survey and Databases
2.3 Potential Funding Sources
2.4 Types of Funding Sources
- Government Agencies
- Foundations and Other Nonprofit Organizations
- Business and Industry
2.5 Limited Submissions
2.6 Executive Vice President for Research Institutional Grant Programs
2.7 Information for Student Researchers
- Vice President for Research Undergraduate Research Scholar Grant (URS)
- Graduate Assistantships
- Student Support and Fellowships

CHAPTER THREE: Proposal Development and Budgeting (11/09/2012)

Types of Proposals
3.1 Preliminary Proposals
3.2 Formal Proposals for Financial Assistance
3.3 Material Transfer Agreements

Proposal Components
3.4 Administrative Information
3.5 Transmittal Letter
3.6 Proposal Cover Page
3.7 Abstract or Project Summary
3.8 Project Description or Proposal Narrative
- Introduction
- Problem or Needs Statement
- Specific Aims: Goals and Objectives
- Methodology
- Evaluation
- Personnel
- Biographical Sketches
- Current and Pending Support
- Facilities and Equipment
- Proposal Appendices
3.9 Proposal Budgeting
- Allowable Costs
- Budget Categories
- Salaries
- Student Salaries
- Fringe Benefits
- Equipment
- Expendable Materials and Supplies
- Tuition
- Consultants
- Subawards
- Travel
- Other Direct Costs
- Facilities and Administrative Costs (F&A)
- Calculating F&A - Modified Total Direct Costs
- Off-Campus Rate
- Industry-Sponsored Clinical Drug Study Rate
- Budget Justification
- Cost Sharing and Matching Costs
- General Guidelines for Cost Sharing

CHAPTER FOUR: Proposal Review, Approval, and Processing (07/18/2011)

4.1 Review and Approval Responsibilities
4.2 Proposal Clearance Form/Multi-Institutional Research Application
4.3 Other Pre-Submission Approvals and Requirements
- Institutional Reveiw Board (IRB)
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee
- Radiation Safety Committee
4.4 Proposal Review
4.5 Pre-Award Audits
4.6 Unfunded Proposals

CHAPTER FIVE: Award Acceptance and Account Establishment (07/18/2011)

5.1 Types of Awards
5.2 Signature Authority
5.3 Establishment of Award Speedtype
5.4 Pre-Award Costs
5.5 Post-Award Costs

CHAPTER SIX: Financial Management of Awards (07/18/2011)

6.1 Criteria for Direct Charging Costs to Sponsored Programs
- Administrative & General Purpose Costs
6.2 Cost Transfers
6.3 Rebudgeting
6.4 Deficit Policy
6.5 Effort and Salary Allocation on Sponsored Agreements
6.6 Effort Reports
6.7 Program Income
6.8 Cost-Sharing Policy for Sponsored Accounts
6.9 Uncollectable Costs
6.10 Service Center Costs

CHAPTER SEVEN: Non-Financial Management of Awards (07/11/2011)

7.1 Post-Award Changes and Approvals
- No-Cost Extensions
- Change in Principal Investigator/Project Director
- Purchasing Procedures
- Equipment Purchases
- Carry forward of Funds
7.2 Purchasing Outside Services
- External Consultants
- Subawards
7.3 Other Award Management Considerations
- Property Management/Disposition
- Intellectual Property
- Publications
- Research Data
- Freedom of Information
- Travel
7.4 Reporting and Closeout
- Reporting
- Closeout
- Final Technical Reports
- Final Invention Report
- Final Financial Reports
- Final Property Reports
- Close-Out Audit
- Residual Funds From Sponsored Projects
- Award Speedtype Closings
7.5 Record Retention
7.6 Transfer of Investigators to Other Institutions
7.6 Communications from Agencies

CHAPTER EIGHT: Industry Awards and Agreements (05/08/2007)

8.1 Industry Sponsored Agreements
8.2 Clinical Study/Trial Agreements
8.3 Service Agreements
8.4 Equipment Loan Agreements
8.5 Material Transfer Agreements
8.6 Special Considerations for Budgeting of Industry Awards

CHAPTER NINE: Research Regulations (07/18/2011)

9.1 Human Subjects Protection Program Office
- Human Subjects Protection Program (IRB)
- IRB Medical
- IRB Behavioral/Social Science/Education
- Definition of Research/What Types of Research Must be Reviewed
- Federal-Wide Assurances
- Human Subjects Protection Program Office
- IRB Policies and/or Procedures
9.2 Animal Subjects
9.3 Institutional Biosafety Committee
9.4 Radiation Safety
9.5 Laser Safety
9.6 Chemical Agents
9.7 Hazardous Chemical and Infectious Waste
9.8 Financial Conflict of Interest in Research
9.9 Misconduct in Research
9.10 Research Activities Performed by Outside Organizations
9.11 Responding to Instances of Non-Compliance
9.12 Committee Information

CHAPTER TEN: Service Centers (08/31/2010)

10.1 Definition
10.2 Regulations and Rates
10.3 Responsibilities
10.4 Establishment Procedure
10.5 User Fee 
10.6 Cost and Revenue Segregation and Allocation
10.7 Equipment
10.8 Over/Under Recovery
10.9 External Users
10.10 Service Center Inventory
10.11 Record Retention

Appendix A - Roles & Responsibilities Matrix



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