ORD Human Research Protection

K. Lynn Cates, MDAssistant Chief Research & Development OfficerFebruary 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 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

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

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

PRIDEOrganizational Structure

C O A C H G U I DE & L I N C

P R I DE

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 & EducationOther Projects

Winter PRIDE Internet presence“Help Desk” – phone & emailVA HRP “family” via ACE! –

mentoring

Spring Combined GCP/HRPP course

Summer/Fall Regular conf callsEmail newsletters & alertsSOPs – standardize throughout VAQuick referencesTools (e.g., IRB self-assessment)

QA/QI programs (e.g., audits)

COACH Communication

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

PRIDEOrganizational Structure

C O A C H G U I DE & L I N C

P R I DE

Living in the “Gray Zone”

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

• 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 2003 Annual Reports – Version 1.1 11 sites – 3 years 7 sites – 1 year

Feb 26 2004 2 Sites - Version 2.1 accredited 3 yrs3 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]

How To Contact PRIDE & COACH

• PRIDEPhone: 202-254-0282Email: Lynn.Cates@hq.med.va.gov

• COACHPhone: 501-257-1705Email: Marisue.Cody@med.va.gov

• Web site: www.va.gov/resdev