# Presentation: 207877

## 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

**P**rogram For **R**esearch **I**ntegrity **D**evelopment & **E**ducation
- Training & education
- Policy development & guidance

## Goal

- To make VA human research the safest in the world

**Regs**

-   Eliminating barriers

-   Changing the culture

## Slide 8

## VA    HRPP

- 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

**C**enter **O**n **A**dvice & **C**ompliance **H**elp
- 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 & 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

## PRIDEOrganizational Structure

## Slide 18

## 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”

**LI**aison & **N**etworking **C**enter
- 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 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]

## 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