ORD Human Research Protection

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ORD Human Research Protection

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• February 25, 2004

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Objectives

• How ORD is going to help you optimize human
  research protection at your facility
• Implications of noncompliance elements of
  success
• Local management of unanticipated events

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Human Research ProtectionProgram

• ORO
• Overview of ORO the Common Rule
• NCQA
• Panel with Version 2.1 NCQA accredited sites
• Affiliate IRB NCQA accreditation
• NCQA accreditation research pharmacies

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Human Research ProtectionProgram

• Pharmacy
• Pharmacists responsibilities in clinical studies
• Panel on research pharmacist issues
• FDA
• Regulations
• Regulatory aspects of adverse medical events
• SOPs
• Organizational structures for RCOs

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PRIDE

• Program For Research Integrity Development
  Education
• Training education
• Policy development guidance

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Goal

• To make VA human research the safest in the world

• Eliminating barriers

• Changing the culture

Regs
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VA HRPP
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VA Research Stand DownJump Start

• Proactive - investment in the future
• Stand Down to prevent Shut Down
• Focus
• Identifying correcting problems
• Empowering everyone in VA research

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What Is PRIDE Doing Long-Term?

• Multi-pronged approach to education, policy
  development guidance
• NCQA accreditation

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PRIDEOrganizational Structure
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COACH

• Center On Advice Compliance Help
• Focus
• Education
• Help
• No question is too dumb!

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COACH Courses

• Leadership Training
• Train-the-Trainer
• ACE! Training
• ACOS AO Training
• Compliance Officer Training
• Research Pharmacist Training
• IRB Chair Training

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Training EducationOther Projects

• Winter PRIDE Internet presence
• Help Desk phone email
• VA HRP family via ACE! mentoring
• Spring Combined GCP/HRPP course
• Summer/Fall Regular conf calls
• Email newsletters alerts
• SOPs standardize throughout VA
• Quick references
• Tools (e.g., IRB self-assessment)
• QA/QI programs (e.g., audits)

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COACH Communication

• In person
• In print
• On the phone
• Online

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PRIDEOrganizational Structure
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Living in the Gray Zone
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Policies Guidance

• Credentialing training
• Guidance for Handbook 1200.5
• Local management of unanticipated events
• Research impropriety
• Electronic consent forms
• Synchronize all 4 ORD services HRP requirements

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Policies Guidance

• Consolidation of IRBs
• Regionalization of IRBs
• Centralization of IRBs
• Issues
• Liability
• Accountability
• MOUs

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GUIDE LINC LINC

• LIaison Networking Center
• Inside VA
• ORD
• ORO, Ethics, Patient Safety
• Outside VA
• NCQA, AAHRPP
• HHS - OHRP, FDA, NIH
• PRIMR, AAMC, Kaiser-Permanente

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NCQA Accreditation

• Fall 2003 Annual Reports Version 1.1
• 11 sites 3 years
• 7 sites 1 year
• Feb 26 2004 2 Sites - Version 2.1 accredited 3
  yrs
• 3 Sites pending final results
• 2004 Accredit 1/3 of all sites
• 2005 Accredit 1/3 of all sites
• 2006 All sites accredited

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Version 2.1 NCQA Accreditation

• Memphis
• Hines
• Long Beach
• Iowa
• Indianapolis

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How To Contact PRIDE COACH

• PRIDE
• Phone [phone]
• Email Lynn.Cates_at_hq.med.va.gov
• COACH
• Phone [phone]
• Email Marisue.Cody_at_med.va.gov
• Web site www.va.gov/resdev