# Presentation: 335282

- K. Lynn Cates, MD
- Assistant Chief Research & Development Officer

- PRIDEProtecting Patients – Protecting You

## Objectives

- What’s new in human research protection at the VA?
- How ORD is going to help you optimize human research protection?

## VA Human Research Protection

- ORO - **O**ffice of **R**esearch **O**versight
- Compliance & oversight
- PRIDE - **P**rogram for **R**esearch **I**ntegrity **D**evelopment & **E**ducation
- Policy development & guidance
- Training & education

## PRIDEWhat Are We Doing?

- Eliminating barriers to protecting
- VA human research participants

## Slide 5

## Slide 6

## Slide 7

## Slide 8

## Slide 9

## Slide 10

## VA    HRPP

- VA    HRPP

## Research Stand Down“Jump Start”

- Investment in the future
- Stand Down to prevent “Shut Down”
- Focus
- Identifying & correcting problems
- Empowering *everyone* in VA research

## Research Stand DownComponents

- Training
- Credentialing
- Verifying effectiveness of your human research protection program (HRPP)

## Research Stand DownTraining

- Courses
- Human research participant protection
- Good Clinical Practices (GCP)
- Requirement
*All* members of the VA research team

## Research Stand DownCredentialing - What?

- Verifying with primary source
- Education
- Licensure
- Relevant training and experience
- Developing a scope of practice
- Checking against exclusionary lists

## Research Stand DownCredentialing - Who?

*Everyone* involved in human subjects research
- Investigators
- Study coordinators
- Staff who work with patients in person or by phone
- Research staff who collect and analyze data
- Research laboratory personnel
- WOCs

## Annual Research Requirements

- Training
- Human research participant protection
- Good Clinical Practices
- Credentialing
- Confirm licenses
- Check against exclusionary lists

## Verifying Effective Oversight byYour R&D Committee & IRB

- Who is responsible?
- Medical Center Director
- Chief of Staff
- ACOS/R

## Verifying Effective Oversight byYour R&D Committee and IRB

- Kinds of questions you need to ask:
- Are your policies & procedures current?
- Is your Federalwide Assurance (FWA) current?
- Do your human research protection personnel have appropriate qualifications?
- Have you provided them adequate resources?

## Verifying Effectiveness of Your R&D Committee & IRB

- Do you have a procedure for regularly reviewing these committees?
- Do you know if they:
- Have appropriate membership?
- Meet often enough to provide timely review & oversight?
- Follow required policies & procedures?

## Stand Down Results

## Slide 22

## What Is PRIDE DoingFor You Long-Term?

- New services: multi-pronged approach
- NCQA accreditation update

## PRIDE Centers

## COACH

- PRIDE’s **C**enter **O**n **A**dvice &
-    **C**ompliance **H**elp
- Focus
- Education
- Help

## COACH

- Multi-pronged approach:
- In print
- On the phone
- Online
- In person

## COACH Teams

## COACH Teams

- SMART – **S**ite **M**onitoring **A**nd **R**eview **T**eam
- Good Clinical Practices & other courses
- “SWAT” team
- ACE! – **A**ccreditation **C**onsulting **E**xperts
- Dream Team

## GUIDE

- PRIDE’s** **policy **GUID**anc**E** & development center
- New policies
- HIPAA & the Privacy Act
- Handbook 1200.5
- Conflict of interest
- Research misconduct
- Tissue banking
- Blue Ribbon Panel

## LINC

- PRIDE’s** LI**aison & **N**etworking **C**enter
- Inside VA
- ORD
- ORO
- Patient Safety, Ethics, etc.
- Outside VA
- NCQA
- OHRP
- FDA, NIH, etc.

## UpdateNCQA Accreditation

- April 2003			V 2.1 standards
- 					Pause lifted
- June 2003			Training
- Summer 2003		First sites submit paperwork
- Fall 2003			First surveys
- 					More sites submit paperwork
- Summer 2005		All sites accredited

## NCQA Accreditation Plan

- Training for all sites in 2003
- Scheduling for accreditation process
- 		Any volunteers for November????
- Consolidation of IRBs
- Accreditation for sites whose IRB is at their academic affiliate
- Surveyor training

## Train-The-Trainer

- PRIDE + ORO + NCQA

## Slide 34

## Slide 35

## 			HRPP

## Secretary Principi’s List

- Research funding
- Non-profit research corporations
- Legal issues
- HIPAA & the Privacy Act

## Secretary Principi’s List

- Program protocols
- Informed consent
- Managing IRBs
- Compliance
- Credentialing
- Ethical considerations

## PRIDETake Home Message

- Protecting patients
- Protecting you
- We want to know how can we help you

## How To Contact PRIDE & COACH

- PRIDE
- Phone:**  **202-254-0282
- Email: Lynn.Cates@hq.med.va.gov
- COACH
- Phone:  501-257-1705
- Email:**  **CodyMarisue@uams.edu
- Web site:  www.va.gov/resdev