Leading by Example

1
Leading by Example

• A Word with Research Compliance Officers
• from the Department of Veterans Affairs
• What We Do and How We Do It

Mary Costigan, RN, MSN, CIP Philadelphia VAMC
Kathy Schulz, CIP San Francisco VAMC
2
RCO

• RCO has Oversight for
• Human Subjects Program
• Institutional Animal Care and Use Program
• Research Safety
• Research Credentialing
• Accreditation Agencies

3
RCO

• RCO Philadelphia
• Chair Human Subject Protection Program Committee
• Chair Financial Conflict of Interest Committee
• Supervises
• RD Coordinator/Grants
• IRB Coordinators (2)
• Quality Management Specialist
• Reports to
• Vice President of RD

4
Philadelphia VAMC

• Centers of Excellence
• CHERP-retrospective, database, disparity
• PADRECC-movement, rehab, taste, smell, UTI, QOL
• MIRECC-Substance abuse, PTSD and Sleep
• Active Protocols
• 220 Human Subject
• 30 Animal
• Affiliate University of Pennsylvania

5
Visibility Accessibility

• Be available to researchers and staff
• Go to them
• Grand Rounds / MM
• Committee Service
• Be part of the
  teaching environment
• Give seminars
• Mentor
• Students / residents / fellows /
  young investigators and .
  . .
  full professors
• Tour Guide through the
  regulatory jungle

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Keys for Success

• Pre-review and critique submissions
• Approach every encounter as an opportunity to
  teach best practices
• Educate non-researchers
• Avoid misunderstanding of what is research
• Make them aware of research needs, benefits and
  limits
• Make sure everybody knows who to call

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Finding Problems

• Quality Assurance
• Audits
• Monitoring
• Peer Review
• Not just for researchers
• Committees
• Desk Practices / Office Staff
• Confessions
• Required Reporting by research staff
• Inquiries
• Complaints

8
Approaching the Confessional

• Do you provide a welcoming forum for confession?
• When mistakes happen are your researchers willing
  to confess . . . or tempted to bury the bodies?
• How is confidentiality maintained?
• Can folks get a fresh start?

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When things go Wrong

• Working with an affiliate
• Reporting to ORO / OHRP /OLAW
• Accreditation reporting
• Share mistakes (only you can prevent forest
  fires)
• Add lessons learned to
• in-house trainings
• Update forms / practices

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Growing the Regulations

• Partner with researchers
• Develop best practices
• Learn more about the local research interests
• Walk a Mile in their Moccasins
• Evolving science leads to evolving regulatory
  practice
• Establish your teams education goals
• Areas of Expertise
• Emerging issues (e.g., IT concerns)
• Serve on diverse committees
• Network

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Nuts Bolts

• Research Safety
• Human Subjects
• Animal Welfare
• Information Technology

• Stakeholders AdHoc Experts
• Communication
• CQI Strategies
• Other Tools