Condensed Executive Summary

1.1 Introduction
1.1.1 Objective
1.1.2 Scope of the Review Process

1.2 Principal Findings


1.2.1 Conflict Review Committee
1.2.2 Principal Investigator Responsibility
1.2.3 Subjects Protection Programs - Human Subjects
1.2.4 ORTTA - Patents and Technology Marketing (PTM)
1.2.5 ORTTA - Sponsored Projects Administration
1.2.6 Coordination of Clinical Trials Review Processes
1.2.7 General Clinical Research Center
1.2.8 Monitoring Compliance with Research Regulations

1.3 Recommendations

1.3.1 Disband the Conflict Review Committee
1.3.2 Establish a Research Support Service Office
1.3.3 Establish a Business Development Office
1.3.4 Enhance Performance of Subjects Protection Programs - Human Subjects Review Process
1.3.5 Improve and Expedite Contract Review and Negotiation
1.3.6 Establish a Clinical Trials Coordinating Center
1.3.7 Provide Support for Regulatory Compliance Monitoring

1.4 Conclusion

2.0 IMPROVING EXISTING STRUCTURES AND PROCESSES [99K]

2.1 Introduction

2.2 Conflict Review Committee (Board of Regents' Conflict of Interest Policy) and Board of Regents' Academic Misconduct Policy


2.2.1 Current Performance - Conflict Review Committee
2.2.2 Current Performance - Application of Academic Misconduct Policy
2.2.3 Goals and Recommendations for Conflict Review Committee
2.2.4 Goals and Recommendations Regarding Application of the Academic Misconduct Policy
2.2.5 Rationale
2.2.6 For More Information

2.3 Subjects Protection Programs (Human and Animal Subjects) Human Subjects

2.3.1 Current Performance - Human Subjects Protection Programs
2.3.2 Goals and Recommendations - Human Subjects Protection Program
2.3.3 Rationale

2.4 Subjects Protection Programs (Human and Animal Subjects) - Animal Subjects

2.4.1 Current Performance - Animal Subjects Protection Program
2.4.2 Goals and Recommendations - Animal Subjects Protection Program
2.4.3 Rationale
2.4.4 For More Information

2.5 Office of Research Technology Transfer Administration (ORTTA)

2.5.1. Current Performance - Patents and Technology Marketing (PTM)
2.5.2 Current Performance - Sponsored Projects Administration (SPA)
2.5.3 Goals and Recommendations - Patents and Technology Marketing
2.5.4 Goals and Recommendations - Sponsored Projects Administration
2.5.5 Rationale
2.5.6 For More Information

2.6 Department of Environmental Health and Safety
2.6.1. Current Performance
2.6.2 Goals and Recommendations
2.6.3 Rationale
2.6.4 For More Information

2.7 General Clinical Research Center

2.7.1 Current Performance
2.7.2 Goals and Recommendations
2.7.3 Rationale

2.8 Ongoing Compliance with Research Regulations

2.8.1. Current Performance of Compliance Functions
2.8.11 Subjects Protection Programs : Human Subjects (IRB) and Institutional Animal Care and Use Committee (IACUC)
2.8.12 Department of Environmental Health and Safety (DEHS)
2.8.13 Conflict Review Committee (CRC)
2.8.14 Scientific and Scholarly Advisory Board
2.8.15 The General Clinical Research Center (GCRC)
2.8.16 Cancer Center
2.8.2 Goals and Recommendations
2.8.21 Subjects Protection Programs
2.8.22 Department of Environmental Health and Safety (DEHS)
2.8.23 Conflict Review Committee (CRC)
2.8.24 Scientific and Scholarly Advisory Board
2.8.25 GCRC
2.8.26 Cancer Center
2.8.3. Rationale
2.8.4 For More Information

3.0 PROVIDING SUPPORT TO AHC INVESTIGATORS: RESEARCH SUPPORT SERVICE OFFICE [132K]

3.1 Introduction
3.1.1 Current Performance
3.1.11 Proposal/Protocol Review of Industry Sponsored Trials
3.1.12 Conflict of Interest and Academic Misconduct
3.1.13 Budget Preparation and Negotiation
3.1.14 Contract Review and Negotiation
3.1.15 Subjects Protection Programs
3.1.16 BA 23 and Account Assignment
3.1.17 Managing Project Changes
3.1.18 Managing Research Funds
3.1.19 Closing the Project

3.1.2 Goals and Recommendations
3.1.21 Proposal/Protocol Review of Industry-Sponsored Trials
3.1.22 Conflict of Interest and Academic Misconduct
3.1.23 Budget Preparation and Negotiation
3.1.24 Contract Review and Negotiation
3.1.25 Subjects Protection Programs
3.1.26 BA 23 and Account Number Assignment
3.1.27 Managing Project Changes
3.1.28 Managing Research Funds
3.1.29 Closing the Project

3.2 Research Support Services
3.2.1. Proposal/Protocol Review
3.2.11 Review for Scientific Merit and Consistency with Mission and Goals of the AHC
3.2.12 Feasibility Review
3.2.13 Patient Population
3.2.14 Core Facilities and Resources
3.2.15 PI Commitment - Time and Other
3.2.16 Naming the Research Team
3.2.17 Sponsor Regulatory Documents

3.2.2 Conflict of Interest Review and Management
3.2.21 Review of Faculty Members and Research Investigator's External Relationships
3.2.22 Review of the Study Research Design
3.2.23 Responsibility Indicated by Conflict Review Document Signatures
3.2.3 Budget Preparation and Negotiation
3.2.31 Determination of Actual Costs
3.2.32 Preparation of the Draft Budget
3.2.33 Negotiation with the Sponsor
3.2.4. Contract Review and Negotiation
3.2.41 Initial Contract Review
3.2.42 Negotiation and Approval of Contracts
3.2.5 Protection of Human Subjects
3.2.51 Protocol Review
3.2.52 Preparation of Human Subjects Application and the Consent Form
3.2.53 Protection of Human Subjects Application Review Process
3.2.54 Management of Protocol Changes
3.2.55 Reporting Serious Adverse Events (SAEs)
3.2.56 Retention of Records
3.2.6 Protection of Animal Subjects
3.2.61 Protocol Review
3.2.62 Protection of Animal Subjects Application Review Process
3.2.63 Management of Research Protocol Changes Using Animals
3.2.7 Biohazards and Other Health and Safety Compliance
3.2.71 Review of Potential Hazards
3.2.8 BA 23 and Account Assignment
3.2.81 Completing the BA 23
3.2.82 BA 23 Review and Approval
3.2.83 Responsibility Indicated by Approval Signatures
3.2.84 Reporting the Project to Departments/Institutes/Centers
3.2.85 CUFS Account Number Assignment
3.2.9 Managing and Reporting Investigator and/or Protocol Changes
3.2.91 Conflict of Interest
3.2.92 Budget
3.2.93 Contract
3.2.94 Biohazards
3.2.95 Human Subjects
3.2.96 Animal Subjects
3.2.97 FDA 1572
3.2.98 Data Monitoring and Audits by Sponsor/CRO/FDA
3.2.10 Managing Research Funds
3.2.101 Approving Purchases
3.2.102 Monitor Contract Benchmarks and Payment Schedules
3.2.103 Monitor Charges by ISO's and Other Internal Services
3.2.104 Report to Investigators and Departments
3.2.105 Monitor Effort Certification for the Project
3.2.11 Study Close Out
3.2.111 Regulatory Documents Review
3.2.112 Final Report to the IRB
3.2.113 Final Report to the Sponsor
3.2.114 Review of Final Account Status and Contract Terms
3.2.115 Closing the Account
3.2.116 Final Report to the Department
3.3 Business Development Office
3.3.1 Introduction
3.3.2 Recommendations
3.3.3 Financial Administration
3.3.31 Revenues
3.3.32 Budget & Cash Flow

4.0 CONCLUSION

5.0 APPENDICES

5.1 Conflict of Interest
5.2 Academic/Research Misconduct
5.3 Protection of Human Subjects
5.4 Protection of Animal Subjects
5.5 ORTTA
5.6 Department of Environmental Health and Safety
5.7 General Clinical Research Center
Cancer Center
5.8 General Appendices