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

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Presentation transcript:

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 Local management of unanticipated events

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

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

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

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

VA HRPP

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

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

PRIDE Organizational Structure

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

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

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

COACH Communication In person In print On the phone Online

PRIDE Organizational Structure

Living in the “Gray Zone”

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

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

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

NCQA Accreditation Fall 2003Annual Reports – Version sites – 3 years 7 sites – 1 year Feb 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

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

How To Contact PRIDE & COACH PRIDE Phone: COACH Phone: Web site: