ORD Human Research Protection K Lynn Cates MD

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

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

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

Human Research Protection Program • ORO • • Overview of ORO & the Common Rule NCQA • • • Panel with Version 2. 1 NCQA accredited sites Affiliate IRB & NCQA accreditation & research pharmacies

Human Research Protection Program • Pharmacy • • • FDA • • Pharmacists’ responsibilities

Human Research Protection Program • Pharmacy • • • FDA • • Pharmacists’ responsibilities in clinical studies Panel on research pharmacist issues Regulations Regulatory aspects of adverse medical events SOPs Organizational structures for RCOs

PRIDE Program For Research Integrity Development & Education • Training & education • Policy

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

Goal To make VA human research the safest in the world • Eliminating barriers

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

VA HR PP

VA HR PP

VA Research Stand Down “Jump Start” • Proactive - investment in the future •

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

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

PRIDE Organizational Structure

PRIDE Organizational Structure

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

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

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 &

Training & Education Other 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)

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

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

PRIDE Organizational Structure

PRIDE Organizational Structure

Living in the “Gray Zone”

Living in the “Gray Zone”

Policies & Guidance • • • Credentialing & training Guidance for Handbook 1200. 5

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

Policies & Guidance • Consolidation of IRBs Regionalization of IRBs Centralization of IRBs •

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

GUIDE & LINC –”LINC” LIaison & Networking Center • Inside VA • • •

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 2003 Annual Reports – Version 1. 1 11 sites – 3

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

Version 2. 1 NCQA Accreditation • • • Memphis Hines [Long Beach] [Iowa] [Indianapolis]

Version 2. 1 NCQA Accreditation • • • Memphis Hines [Long Beach] [Iowa] [Indianapolis]

How To Contact PRIDE & COACH • PRIDE Phone: 202 -254 -0282 Email: Lynn.

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