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 Protection Program 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 Protection Program 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 Regs Eliminating barriers Changing the culture

9. VA HRPP

10. 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

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

12. PRIDE Organizational Structure

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

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

15. Training & Education Other Projects Winter PRIDE Internet presence “Help Desk” – phone & email VA HRP “family” via ACE! – mentoring SpringCombined GCP/HRPP course Summer/FallRegular conf calls Email newsletters & alerts SOPs – standardize throughout VA Quick references Tools (e.g., IRB self-assessment) QA/QI programs (e.g., audits)

16. COACH Communication In person In print On the phone Online

17. PRIDE Organizational Structure

19. Living in the “Gray Zone”

20. 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

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

22. 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

23. NCQA Accreditation Fall 2003Annual Reports – Version 1.1 11 sites – 3 years 7 sites – 1 year Feb 26 20042 Sites - Version 2.1 accredited 3 yrs 3 Sites – pending final results 2004Accredit 1/3 of all sites 2005Accredit 1/3 of all sites 2006All sites accredited

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

26. 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