Inside the VA/DoD Collabor

Collabor

Guidebook for Healthcare Re

National Cyber SeminarJune 23, 2011
Purpose

The purpose of this

Guidebook is to facilitate

collaborative humansubject healthcareresearch between theDepartment of

Veterans Affairs (VA) and

the Dtt epar ment of

Defense (DoD)
History of Guidebook Projec

Planning

Initiated

and

funded by

VA HSR&D

Planning

committee

convened

March

2010

Feedback

from

Advisory

Committee

Revisions,

review,

revisions,

review,

revisions

Team led

by Drs.

Resnik and

Reiber

Content

identified

Sections

drafted,

reviewed by

collaborators

Final

version
Authors

• Linda Resnik, PT, PhD• Gayle Reiber, MPH, PhD• Pam Steager• LTC Rachel Evans, PT, PhD• Kate Barnabe, MHA• Katie Hayman, MBA
Acknowledgments

Ben J. Balough, CAPT, MC, USNUS Navy Medicine Research and Development CenterLTC Teresa L. Brininger, PhD, MBA, OTR/L, CHTUS Army Telemedicine and Advanced Technology Research Center

COL Janet Harris, RN, PhDUS Army Clinical & Rehabilitative Medicine ResRobert Jaeger, PhDVA Rehabilitation Research & Development

Laura Ruse Brosch, RN, PhDUS Army Office of Research ProtectionsAmy Centanni, JDVA Office of Research & DevelopmentDouglas B Cooper PhD 

Robert N Kang, Lt Col , USAF, OD, PhDUSAF Chief, Life Sciences and Human FactorsAnnmarie Kelleher, MS, OTR/L, ATP, CCRCHuman Engineering Research Laboratories 

Douglas B. Cooper, PhD LTC Molly Klote MD CIP MCMilitary Brain Injury Rehabilitation Research ConsortiumRory Cooper, PhDVA Pittsburgh Healthcare SystemMichael Dandenault, Ph

D

LTC Molly Klote, MD, CIP, MCDoD Clinical Investigation Regulatory OfficeRegina Lynch 

VA Providence Medical Center

, Cheryl C. Odle, MBA

Defense and Veterans Brain Injury CenterMarla J. De Jong, Col, USAF, NC, PhDTriService Nursing Research ProgramSeth Eisen, MD, MScVA Health Services Research & Development

y ,

Edward Hines, Jr. VA HospitalMark D. Packer, Lt Col, USAF, MC, FSDoD Hearing Center of Excellence Theresa L. Pape, BS, MA, DrPH

VA Health Services Research & Development Edward Hines Jr VA HospitalCOL Charles C. Engel, MD, MPHDoD Deployment Health Clinical Center Christine Fitzgerald, MPHVA Providence Medical Center

Edward Hines, Jr. VA HospitalMelissa A. Polusny, PhD, LP Minneapolis VA Health Care SystemMary Jo V. Pugh, PhD, RNSouth Texas VA Healthcare S

ystem

Robert GaileyVA Functional Outcomes Research & Evaluation CenterJoel GloverUS Army Medical Research and Materiel Command 

y

Karen S. Quigley, PhD

Center for Health Quality, Outcomes and Econ

Laura ThompsonVA Providence Medical Center

Dr. Andrew Guccione, PT, PhD, DPT, FAPTA

VA Health Services Research & Development

Jason M. Wilken, PhD, MPT

Military Performance Lab Center for the Intrepid
Wh t’ a s in the G id b k? uidebook?

Section I: OverviewSection II: Nuts and Bolts

Research infrastructure Human research pro

Where to start Data security and res

Seeking a collaborator Media relations/pub

Planning a proposal Case examples

Administration of research funds Recommendations

Formalizing an agreement

Section III: Appendices

Acronym list T l emp ates, sample d

DoD Clinical Investigation Programs

by Region
Why Collaborate?

To answer

research

questions

Why Collaborate?

Shared

responsibility

Pooling of

financial and

human

resources

VA‐D Do

COLLABORATION

Share skills

in navigating

Department

l /

Sharing of

expertise /

i culture/

policies

perspective

Increase

efficiency and

funding

opportunities

Gain greater

credibility

opportunities
GUIDEBOOK TIP

Experienced investigators wa

is inadvisable

for an inexperi

assistant professor or junior

investi

gator seekin

g an inde

p

research career to be involve

collaborative

p j ro ects as PI, d

complexity and length of tim

involved.
Guide to Research Infrastructu

The Guidebook describes research infraof:

VA Army

Navy Air Force
CONGRESS

Office of the

Secretary of Defense

Department of Defense

• Research, Development, Test,

and Evaluation

Assist

Air Force

• Defense Threat Reduction Agency• Defense Advanced Projects Agency

• Res

Tes

and Evaluation

• Operational Maintenance

• Advanced Concept Technology Demonstrations

• Family Assistance• US Special Operations Command

• Op

• Pro

Air Force Medical Service

Air Force Medical Support Agency SGE‐C

SG5 (Acquis

Surgeon General (Modernization)

Compliance

Clinical

Investigation

Facilities

Air Force

Research

Locations
Planning Your Proposal

C id ons er:

Funding Human subjects Scientific Development of collaborative Data sharing Sta

g source subjects

concerns methodology collaborative agreements Data sharing Sta
GUIDEBOOK TIP

When planning your re

develop a back-up p

possibilities like colla

reassignment or deplo
Funding Sources

• Identifies Identifies sources sources of research research funding funding• Provides links to intramural and extra

funding announcements
DoD Research Funding Opportunities S

SOURCE OF SUPPORT TYPE OF AWARD TYPE OF FUNDS

(P6, P8)

WHO 

US Army Clinical Investigation Program (CIP) Intramural funding P8 Military inv

DoD Research Funding Opportunities, S

US Army Clinical Investigation Program (CIP)http://fhp.osd.mil/cip.jsp

Intramural funding P8 Military inv

US Army Medical Research & Materiel Commandhttps://mrmc.amedd.army.mil/index.cfm?pageid=medical_r_and_d.overview

Intramural funding to laboratories (i.e. ISR)

P6 Investigator

research lab

Telemedicine and Advanced Technologies Research Centerhttp://www.tatrc.org/?p=funding_aamti

AAMTI funding P8 Military or G

investigator

Navy Commander’s grants

htt // il/C t t G t /F di

Local intramural f di

P8 Navy resear

http://www.onr.navy.mil/Contracts‐Grants/Funding‐ tOpportunities.aspx

funding centers

Navy Clinical Investigations awardshttp://www.onr.navy.mil/Contracts‐Grants/Funding‐

Opportunities.aspx

BuMed intramural funding

P8 Navy resear

(collaborati

pp p

Wounded, Ill and Injured Program (WII)http://www.onr.navy.mil/Contracts‐Grants/Funding‐Opportunities.aspx

BuMed intramural funding 

P8 Military inv

permitted)

Office of Naval Research (ONR) Office of Naval Research (ONR) Intramural and P6 Military indhttp://www.onr.navy.mil/

Intramural andextramural

P6 Military, ind

defined pro

Air Force Clinical Investigation Programhttp://fhp.osd.mil/cip.jsp

Intramural funding P8 Military inv

Air Force Intramural Researchhttp://www.wpafb.af.mil/library/factsheets/factsheet.asp?id=8981

Research management working group

P6 Air Force re

working on thrust areas
Get Leadership Involved!

Meet with your proposed collabora

members members of their leadership leadership team 

research infrastructure to cement 

rel ti hi lationship and ensure th t a everyon

board.
Administration of Funds

Highlights key aspects of administration of fu

including:

Hiring

personnel Travel Consult

Supplies and Stipends Equipment
Formalizing an Agreement

C i R h d MemorandCooperative Research and

Development Agreement

(CRADA)

Memorand

Agreement 

Memorand

U d t di 

(CRADA)

• Legal, enforceable

Understandin

• Binding legal d

agreement

• Usually between a federal

agency and one or more

that holds part

responsible to 

agency and one or more commitment o

non‐federal parties

commitment o

partnership
Key Content Areas for Researc

A t greements

Resource Sharing Research RolResource Sharing Respon

Reporting of Eac

Negotiating and

Protection of

ll l Data Use Issues Human 

Intellectual

Property

Data Use Issues Iss
TIPS for Navigating VA and DoD 

9 Have experienced experienced assistance assistance for each party9 Identify which IRBs must approve9 Check with all IRBs as they may have differing differing requirements requirements9 Leave plenty of extra time to prepare the application(s)9 Have a contact person at each IRB; contact that person to en

using the most current forms & templates

9 Have each IRB “pre‐review” the application

9 The IRB approval process for a multi‐site project is a serial 

take between 12‐18 months.

9 Develop Develop an appropriate appropriate timeline timeline prior to grant submission submission9 Get letters of support and/or signed impact statements from 

departments and services

9 Have a trained, qualified Principal Investigator at each study 
Data Sharing and Resources

• Access to medical records and

protected health information information is

limited to research and/or

clinical staff within each agency

• Working out a data collection,

sh i ar ng and anal i ys s plan is

critical to the success of a

collaborative project
Data Sharing and Resources

VA Data Sharing D D D t S

Agreements

DoD Data S

Agreeme

• CRADA• Data Collection

• TRICARE Manag

Data Collection Activity DUA

Agreement

• Data Use Agreement

y

• BAA• Computer Matc

(DUA)

• Business Associates

Agreement (BAA)

Agreement (CM

(BAA)
GUIDEBOOK TIP

Both VA and DoD facili

varying levels of s

s

clearance, creden

appointments (i e. . VA 

information securit

requirement

This process can

b

e

l 

e

can hold up study acti

done

i

n

a

dvan
Case Examples

HEROES Project Severe TBI studies Co

Reinteg

Mentored Research

Training Initiative

Empirically‐Based

Cognitive Rehabilitation:

the SCORE Study

Nation

Service 

Veterans 

/ Training Initiative the SCORE Study Collaboration and OIF/

Trauma
Questions

1. How did you identify collaborators and build collaborative rel

your research?

2. What has been the greatest challenge and the greatest rewar

encountered encountered as a result of collaborative collaborative research? research?

3. How was your research funded?4. Did you encounter encounter start‐up delays? delays? If so, do you have any adv

investigators as to how these types of delays could be avoided

5. What type of agreement did you have between the VA and Do

did it take to formalize your agreement?

6. Please share your top two recommendations to investigators 

collaborative research

7. Please talk about your experience in working IRBs from severa8. What special special considerations considerations have you encountered encountered for PR and 
Link to Guidebook Online:

http://www.research.va.gov/va‐

Feedback and updated information for this Guidebo

sent to: vhaprovadodguidebook@va.gov