VA Central IRB

HSR&D & QUERI Projects

Cyber Seminar

Working with the VA Central IRB

November 7, 2012
Presentation Outline 

• What studies need to come to the VA C

• What is engagement in human subjects res

What is engagement in human subjects res

• How is engagement determined? 

• What is the VA Central IRB process? 

• What are the responsibilities of the VA Cen

What are the responsibilities of the VA Cen

• What are the responsibilities of the local sit

• Wh d l i h VA C l IR

What causes 

d

elays in t

he VA 

Central IR

process? 

• Q & A 
What studies What studies must come to come to 

the VA Central IRB? 

• ORD-funded studies with more than one 

engaged in the conduct of human subje

research 
What does “engaged” mean? 

• Engagement 

• VHA Handbook 1200.05, Paragraphs 50-51 • Guidance from the Office for Human Resea

Protections (OHRP), October 16, 2008 http://www.dhhs.gov/ohrp/policy/engage08

• Multi-site studies 

• VHA Handbook 1200.05, Paragraph 52 
t t 

Engaged* in Human Subjects Resear

In general, a VA facility is “engaged” in hum

research when someone with an appointme

th t f ilit that facility obt ia ns f th f th for the purposes of the 

research study 

• Data about the subjects of the research through 

intervention or interaction with them 

• Id tifi bl i i f ti Identifiable private information ab t h 

bout the su

the research 

• The if d tn ormed consent of h bj t f t

f human subjects for t

research 

• Funding for the research • Funding for the research 

*VHA Handbook 1200.05, Paragraph 50 
Why is Engagement Important? 

If a VA facility is engaged in human subresearch it must research it must 

• Hold a Federalwide Assurance (FWA) • Have a local VA investigator for that stu• Have one of its IRBs of record approve t

Have one of its IRBs of record approve 

• The VA Central IRB is one of the IRBs of rec

of the 109 VA facilities that can conduct humof the 109 VA facilities that can conduct hum

research 

VHA Handbook 1200.05, Paragraph 50 
a o a are

Engagement Determinations Engagement Determinations Significance for HSR&D & QUERI Stu• HSR&D & QUERI investigators can perfo

studies t ther VA f cilities that studies at other VA facilities that are noengaged without getting the other faciliIRBs’ approval IRBs’ approval – e g they can e.g., they can 

• Administer surveys or questionnaires to the 

f l ’ l facilities’ employees or patients 

• Hold focus groups of the other facilities’ em

patients 

• Need to notify Director of non-engaged 

y gg 

may disapprove. 
can c

Who makes engagement determinat• If the PI’s assessment is that only his/h

engaged the local IRB onfirm

• If it is not clear which sites are engaged

and ORO work together to make a deteand ORO work together to make a deteengaged, the local IRB can confirm 

• If the PI has any question about how m

are engaged, the project should be senVA Central IRB for a determination 
What kind of information is needed t

What kind of information is needed t

an engagement determination? 

• Who is the sponsor? 

• If funding comes through a Nonprofit or if s

If funding comes through a Nonprofit or if s

are hired by the Nonprofit, the Nonprofit is 

• What sites will be participating (e g wh

What sites will be participating (e.g., wh

are providing vs. obtaining the data; wh

questionnaires or surveys will be adminquestionnaires or surveys will be admin
What kind of information is needed t

What kind of information is needed t

an engagement determination? 

• Who is doing what? 

• Who obtains informed consent obtains informed consent

? 

• Who interacts/intervenes? 

• Who provides private identifiable informat• Who obtains private identifiable informatio• Who uses, studies, or analyzes private i

information? 

• Where are investigator & other research 

appointments? 
VA Central IRB Process VA Central IRB Process 

Pre-submission Consultation • Do I need to submit to the VA Central I• Engagement Determination • Handling Multi Handling Multi 

-Phase Studies Phase Studies 

• Contact VA Central IRB Administrator (A

A d ) f th A

n

derson

) or one of the co-Ch i a rs 
What if the study has multiple phase

• E l xamp e: 

• Phase 1. Investigators at one VA facility to d

national database 

• Phase 2. Investi

g ators at 4 VA facilities will s

employees at 20 VA facilities. Survey is to be analysis of Phase 1 data 

• Phase 3. Design of Phase 3 will depend on re

Phase 2 

(VA Central IRB will review each phase sequentially so you switch IRBs after Phase 1 when more than one site becomhuman subjects research) human subjects research) 
PI/SC Application Review Process 

• VA Central IRB Manager - administrative review • Re

g y ulatory staff – re

g y ulatory review

• Two pathways: 

• Full Committee Review: Primary Secondary and Info

Full Committee Review: Primary, Secondary, and Info

Consent Reviewers 

• Expedited Review: Single Reviewer with final review 

Expedited Review: Single Reviewer with final review 

by one of the VA Central IRB Co-Chairs 
pe o m e e s

PI/SC Application Review Process 

• VA Central IRB Privacy Officer & Informatio

Office (ISO) f thei i Officer (ISO) perform their reviews 

• Reviewers can contact investigator directly 

questions, or through VA Central IRB staff 
Local Site Involvement 

After the PI/SC application is approved VA Central IRB VA Central IRB contingent upon local 

contingent upon local 

comment, or approved contingent u

minor modifications minor modifications, then two things 

then two things 

simultaneously at the local level: 

1. Local Site Review Local Site Review - A copy of the approved 

A copy of the approved 

Application packet is sent to each local site 

with a copy of the VA Central IRB approval with a copy of the VA Central IRB approval 

2. Local Site Investigator (LSI) Applications - 

begin preparing LSI applications begin preparing LSI applications 
1. Local Site Review 

• Each local site designee has 15 days to p

comments to the VA Central IRB comments to the VA Central IRB (NOTE: the local IRB does not perform it h l i i f t di t t it 

has no role in review o

f s

t

udies sent 

to 

Central IRB) 

• Comments must be provided to the VA C

IRB by the individual designated by the l

facility Director 
2. LSI Application Process 

• Each Local Site Investigator (LSI) prepar

Local Site Application based on PI/SC ApLocal Site Application based on PI/SC Ap

• The PI/SC reviews all LSI Applications 

consi t s

tency 

• The VA Central IRB will require a justification 

differences between the PI/SC & LSI Applica
Review of Local Site Comments 

•

VA Central IRB reviews all local site com

determines if changes are needed - may 

• No changes, or • Changes in PI/SC Application (may or may n

Changes in PI/SC Application (may or may n

all LSI Applications), or 

• Changes in one LSI Application only (i.e., aff

ff

local site making comment) 
Final Approval by VA Central IRB 

• The VA Central IRB grants final approval of the 

Application once all local comments and other modifi i h b dd d difications 

have 

been addressed 

• Note: The PI/SC Application must be app

prior to approval of any LSI Applications 

• LSI Applications are then approved individually 

LSI conditions have been met 
Continuing Review 

• IRB approval expiration date for all sites in a 

project is that of the PI/SC Application 

(i.e., all PI/SC and LSI applications for a procontinuing review at the same time) 

• PI/SC is notified 90 to120 days prior to app

expiration date; PI/SC sets submission date 

• LSI submits report to PI/SC by PI/SC deadli• PI/SC submits a summary report and copies 

PI/SC submits a summary report and copies 

reports to VA Central IRB by VA Central IRB 
Local Roles 

• Medical Center Director designates a local s

and someone to provide comments to VA C

• Same role for VA Central IRB as for local IR

• R&D Committee • Research Compliance Officer • Local Research Office (e g training credent

Local Research Office (e.g., training, credent

• No role for VA Central IRB studies 

• L l IRB Local IRB • Local Privacy Officer 

• ISO – variable role depending on study 
o or o

What is THE Most Common Cause of 

• Back and forth between IRB and study 

because f unclear insufficient inf rmbecause of unclear or insufficient inform
Avoiding Delays in the IRB Review P

Avoiding Delays in the IRB Review PComplete IRB Applications • Have a clear research question (i.e., hyp

p p p j ) ur

pose of the 

project)

• Provide detailed methodology • Specify the sequence of events so the I

reviewer can follow the flow of the proj

• Ensure data categorized as de-identified 

still identifiable still identifiable 
Avoiding Delays in the IRB Review P

Avoiding Delays in the IRB Review PComplete IRB Applications • Clearly delineate who is performing whi

research research 

-related activities & where they 

related activities & where they 

performed 

• Use active voice not passive and be specif

Use active voice, not passive, and be specif

(e.g., “the Boston study coordinator will obinformed consent, ” not “informed consent 

obtained”) 

• If you are designating someone as a If you are designating someone as a 

“consultant,” “statistician,” “economisprovide a detailed description of his/hresponsibilities 
Avoiding Delays in the IRB Review P

Avoiding Delays in the IRB Review PComplete IRB Applications • Clearly differentiate usual care from res

activities or QA/QI activities activities or QA/QI activities 

• Provide sufficient information for a waiv

of informed consent or HIPAA authorizaof informed consent or HIPAA authoriza

• Provide sufficient information about a d

repository (i.e., by providing information required by 1200.12) 

• Indicate the local VA facilities involved 

Address IRB approval criteria 

• Address IRB approval criteria 
IRB Approval Criteria 

• Risks are minimized • Risk/benefit balance is reasonable • Selection of subjects is equitable Selection of subjects is equitable • Appropriate informed consent will be so

d t d ocumen

ted 

• Informed consent form has si

gnature

blocks/dates 
a

t t t

IRB Approval Criteria • Informed consent is consistent with pro

HIPAA uthorization HIPAA authorization 

• Additional safeguards for vulnerable pop• Data safety and monitoring plan • P i d fid ti lit t t d Privacy and confidentiality protected • VA information security q re uirements m• Conflict of interest managed 

I i lifi d d i d 

• Investigators qualified and trained 
Preventing Delays in VA Central IRB 

Preventing Delays in VA Central IRB 

of HSR&D & QUERI Projects 

• More frequent communication among IR

& members & stud

y ;teams active moni

response times 

• New protocol template for VA Central IR• Other ideas? • New protocol template for VA Central IR

applications; revise applications to more 

friendly for HSR&D studies friendly for HSR&D studies 

• Webinars with newly funded investigato

study coordinators to review IRB applicaprocess 
g

Next Steps 

• Add individuals with HSR&D & QUERI exper

the VA Central IRB (in progress) 

• Implement new protocol template and IRB 

application to help prompt HSR&D & QUERI application to help prompt HSR&D & QUERI 

investigators to provide all necessary inform

• Training for HSR&D & QUERI staff & investig

Training for HSR&D & QUERI staff & investig

(e.g., webinars as needed) 

• P id id t b t d HSR&D & 

Provide guidance to be posted on HSR&D & 

Central IRB web sites (e.g., checklists, exam
t t

Next Steps 

• S l l f ilit ff & h f Survey local facility staff & research teams fo

feedback on VA Central IRB 

• Develop a mechanism for providing construc

criticism back & forth between study teams a

VA Central ff b l IRB staff & members, f l or exampl

• Send comments and/or complaints directly to VA 

IRB staff, or 

• Send anonymously via HSR&D or QUERI staff 

PLEASE NOTE: Vague criticism will not help us improve thWe need to know exactly what is wrong as soon as you idi l ith id b t h k it i issue, along with any ideas about how we can make it rig
VA Central IRB Co VA Central IRB Co 

-Chairs 

Contact Information Robert Hierholzer, MD VA C t l IRB C VA 

Cen

tral IRB 

Co-Ch i a r 

Phone: (559) 225-6100 x5871 or x 5370 

Email: Robert.Hierholzer@va.gov Stephen D. Bartlett, RPh, MSPH Phone: (303) 393 Phone: (303) 393

-5241 

Email: Stephen.Bartlett2@va.gov 
PRIDE 

Contact Information 

K. Lynn Cates, MD Director, PRIDE 

Lucindia Shouse, MS, Program Analyst, PRID

Director, PRIDE 202-443-5648 lynn.cates@va.gov 

202-443-5659 lucindia.shouse@va.go

Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator 

Soundia A. Duche, MAProgram Analyst, PRID202-443-5658 VA Central IRB Administrator 

202-443-5649 annette.anderson3@va.gov 

202 443 5658 soundia.duche@va.go

@ g Theresa M Straut RA

Theresa M. Straut, RAProgram Analyst, PRID202-443-5654 th t t@ theresa.straut@va.gov 
( ) ,

VA Central IRB Managers VA Central IRB Managers Contact Information Evangela Covert, BS Phone: (202) 443-5778 E-mail: evangela.covert@va.gov 

Christie S. O’Brien, BPhone: (202) 443-56

E Tracy Cutler, MPH, CIM, CCRP, CIP Phone: (202) 443-5650 

Email: Christie.Obrie

Hector Ramirez, CIP 

E-mail: tracy.cutler@va.gov Tara L. McDonough, BA, CIP 

Phone: (202) 443-56Email: Hector.Ramire

Tara L. McDonough, BA, CIP 

Phone: (202) 443-5651 Email: Tara.McDonough@va.gov 

Jeffrey Rollins, BA, CPhone: (202) 443-56Email: Jeffrey Rollins

Nikia D. Morris, MSHA, MBA Phone: (202) 443-5787 E il iki i @ 

Email: Jeffrey.Rollins

Email: nikia.morris@va.gov ••