Getting Your Hands Around Research Compliance

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Getting Your Hands Around Research Compliance

• Richard St. Onge
• Assistant Vice Chancellor for Health Affairs

2
Basic Premise

• COMPLIANCE IS A JOURNEY, NOT A DESTINATION

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The Journey
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Executive Sponsorship

• Buy-in from Executive Leadership is Critical
• Chancellor and EVCs
• Presidents
• Chief Research Officers
• Chief Business Officers
• Compliance Officers

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Work Group

• Identify a Leader / Chair
• Select Members Carefully
• Faculty Member / Physician
• Chief Research Officer
• Compliance Officer
• Sponsored Programs Personnel
• Goal Small Work Group, Diverse, Interested, and
  Willing to Work!

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Research the Issue

• Federal Laws, Rules and Regulations
• State Laws, Rules and Regulations
• System Rules, Regulations, Policies and
  Procedures
• Other Higher Education Institutions

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Guiding Principles

• Identifies Key Policy Areas
• Establishes Minimum Standards
• Highlights Areas of Debate
• Circulate to Key Stakeholders
• Work Group Analyzes All Comments

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Policy

• Incorporate / Respond to Feedback
• Re-Issue for Comments?
• Officially Promulgate Policy
• Presentations to Key Stakeholders
• Board of Regents
• Chancellor and EVCs, Presidents, Chief Research
  Officers, Chief Business Officers, and Compliance
  Officers

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Education

• Coordinate with Policy Development
• Key Elements to Consider
• Audience
• Curriculum
• Trainer
• Delivery Method
• Frequency
• Testing

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Monitoring - Believe but Verify

• Based on Risk Assessment
• Develop Compliance Plan
• Coordination Between Compliance Office and
  Departments
• Electronic Tools

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Best Practices

• Compliance Plans
• Peer Review Site Visits
• Process to Re-evaluate Policies
• Continuously Assess Risk
• Incorporate Feedback from Executive Leadership,
  Faculty, Staff
• Workshops to Share Best Practices and Lessons
  Learned

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The Journey
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Conclusion

• COMPLIANCE IS A JOURNEY, NOT A DESTINATION

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Thank You!

• Questions ???