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ORD Human Research Protection

ORD Human Research Protection. K. Lynn Cates, MD Assistant Chief Research & Development Officer February 25, 2004. Objectives. How ORD is going to help you optimize human research protection at your facility Implications of noncompliance – elements of success

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ORD Human Research Protection

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  1. ORD Human Research Protection K. Lynn Cates, MD Assistant Chief Research & Development Officer February 25, 2004

  2. 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

  3. 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

  4. 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

  5. PRIDE Program For Research Integrity Development & Education • Training & education • Policy development & guidance

  6. Goal To make VA human research the safest in the world • Eliminating barriers • Changing the culture Regs

  7. VA HRPP

  8. VA Research Stand Down“Jump Start” • Proactive - investment in the future • “Stand Down” to prevent “Shut Down” • Focus • Identifying & correcting problems • Empowering everyone in VA research

  9. What Is PRIDE Doing Long-Term? • Multi-pronged approach to education, policy development & guidance • NCQA accreditation

  10. PRIDEOrganizational Structure

  11. COACH Center On Advice & Compliance Help • Focus • Education • Help • No question is too dumb!

  12. COACH Courses • Leadership Training • Train-the-Trainer • ACE! Training • ACOS & AO Training • Compliance Officer Training • Research Pharmacist Training • IRB Chair Training

  13. 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)

  14. COACH Communication • In person • In print • On the phone • Online

  15. PRIDEOrganizational Structure

  16. Living in the “Gray Zone”

  17. 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

  18. Policies & Guidance • Consolidation of IRBs • Regionalization of IRBs • Centralization of IRBs • Issues • Liability • Accountability • MOUs

  19. GUIDE & LINC –”LINC” LIaison & Networking Center • Inside VA • ORD • ORO, Ethics, Patient Safety • Outside VA • NCQA, AAHRPP • HHS - OHRP, FDA, NIH • PRIM&R, AAMC, Kaiser-Permanente

  20. 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

  21. Version 2.1 NCQA Accreditation • Memphis • Hines • [Long Beach] • [Iowa] • [Indianapolis]

  22. How To Contact PRIDE & COACH • PRIDE Phone: 202-254-0282 Email: Lynn.Cates@hq.med.va.gov • COACH Phone: 501-257-1705 Email: Marisue.Cody@med.va.gov • Web site: www.va.gov/resdev

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