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ORD Human Research Protection

This presentation by Dr. K. Lynn Cates focuses on enhancing human research protection within VA facilities. It covers the role of ORD in optimizing compliance, addresses noncompliance implications, and outlines successful elements of a Human Research Protection Program (HRPP). Key topics include local management of unexpected events, accreditation processes with NCQA, regulatory requirements, and the importance of training and education. The ultimate goal is to establish the safest research environment possible within the VA system.

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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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