ORD Human Research Protection

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ORD Human Research Protection

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• ACOS/R Meeting, January 2004

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Objectives

• How ORD is going to help you optimize human
  research protection at your facility
• New initiative on local management of
  unanticipated problems in research
• Overview of ethical regulatory issues

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PRIDE

• Program On 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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PRIDE Centers
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COACH

• Center On Advice Compliance Help
• Focus
• Education
• Help

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COACH Courses

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

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COACH Communication

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

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PRIDE Centers
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GUIDE LINC GUIDE

• Policy GUIDancE development center
• Credentialing Training
• Financial Conflict of Interest
• Research Impropriety
• Regional IRBs
• Central IRBs
• Unanticipated Problems in Research

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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

• Spring 2003 Version 2.1 Standards
• New Policies Procedures
• Fall 2003 Annual Reports
• Winter 2003-4 2 Sites - Version 2.1 surveys done
• 3 Sites - Surveys in progress
• 2004 Accredit 1/3 of all sites
• 2005 Accredit 1/3 of all sites
• 2006 All sites accredited

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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