VA Central IRB

VA Central IRB

Annette Anderson, MS, CIPVA Central IRB Administrator

Updated: March 27, 2017

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Purpose of VA Central IRB• Primary Purpose• Improve human research protections in VA

multi-site studies by ensuring:• Consistent expert ethical and scientific review• Local issues are still addressed

• Secondary Purpose• Enhance efficiencies of IRB review in multisite

studies

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VA Central IRB Implementation• Established as part of the VHA Central Office

Human Research Protection Program (HRPP) in 2008

• Institutional Official (IO) is a senior member of VHA Leadership

• First study reviewed in August 2008 and approved in October 2008

• As of March 27, 2017, the VA Central IRB is overseeing or is in the process of reviewing a total of 196 multi-site studies involving a little over 1,250 sites

• The VA Central IRB also approves Requests for Exemptions

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VA Central IRB Composition• 14 voting members including 2 Co-Chairs

and 3 non-scientists• 1 non-scientist alternate • 4 non-voting members• Ethics• Privacy with 1 alternates• Information Security with 1 alternate• Legal

• Ad Hoc Consultants as needed

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VA Central IRB Operations• Staffed by PRIDE• 1 VA Central IRB Administrator• 6 VA Central IRB Managers• 1 Regulatory Analyst• 2 Program Administrators

• Meetings twice monthly via teleconference; two meetings a year in person in Washington, DC

• SharePoint used for submitting and distributing documents and tasking Reviewers

• ACCESS and shared drive data base for tracking and storing data

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What Studies are Reviewed by VA Central IRB?• Studies that receive funding from the VA Office of

Research and Development (ORD) in which multiple VA sites (2 or more) are engaged in human subjects research

• Other designated studies funded by other sources, such as other government entities (DoD), pharmaceutical companies, and research networks

• Currently no charge for use of VA Central IRB for VA-funded studies for studies funded by another federal entity.

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Local VA Facility Requirements to Use the VA Central IRBLocal VA Facilities must:• Amend Facility Federalwide Assurance to list the

VA Central IRB as an IRB of Record; affiliated NPCs must amend FWAs as well

• Enter into a Memorandum of Understanding (MOU) with the VHA Central Office and affiliated NPC if applicable

• Develop Standard Operating Procedures (SOPs) for using the VA Central IRB as an IRB of Record

• Amend affiliate MOU if applicable

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Memorandum of Understanding (MOU)• Spells out the respective authorities, roles, and

responsibilities of the VHA Central Office HRPP, the VA Central IRB, the local VA facility, and the affiliated NPC if applicable

• VA facilities that do not use the VA Central IRB will not be able to participate in studies reviewed by the VA Central IRB

• As of March 27, 2017, the VHA Central Office HRPP has MOUs with 104 VA facilities with FWAs

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Local Accountability for Research• The MOU requires the VA Facility Medical

Center Director to Appoint local Site Representatives to:• Provide local comments to the VA Central IRB

regarding the VA Central IRB’s review of the Principal Investigator New Project Application

• Serve as the Local Site Liaison with the VA Central IRB

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Engagement and Exemptions• Prior to submission of a new project for

review by the VA Central IRB the PI may request if applicable:• An Engagement determination

• An Exemption from IRB Review

• A Human Subjects Research determination

• Administrative Pre-Reviews are also available and highly recommended

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Application Processes – 2 Types

Principal Investigator (PI) Application – Based on IRB approval criteria• Co-PI and Coordinating Center Supplements• Protocol and other documents (i.e., surveys,

scripts, investigator drug brochures)• Waiver requests• Vulnerable Population Supplements• Model Documents (i.e., informed consent form,

recruitment materials, HIPAA Authorization)• COI statements from personnel in investigator

roles only• CVs of investigators only• Local ACOS/R&D certification

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Application Processes – 2 TypesLocal Site Investigator (LSI) Application

–based on and mirrors PI/SC Application• Local study team• Local resources• Local recruitment practices• Local participant compensation practices• Customize model documents• All differences from PI Application must be

justified• Signed by LSI and local ACOS/R certification

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VA Central IRB Review Model – 7 StepsStep 1 - PI completes and submits PI

Application• Contact VA Central IRB Administrator prior to

completing application• Forms on VA Central IRB website• PI enlists local sites and lists them if known• Local Conflict of Interest determination if

feasible• PI/SC signs form and obtains certification from

local ACOS/R&D

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VA Central IRB Review Model – 7 Steps Step 2 – VA Central IRB reviews PI

Application• Initial Reviews

• Administrative • Information Security• Privacy

• Primary Reviewer System • Primary, Secondary, and Informed Consent

Reviewers for studies reviewed at convened IRB Meetings

• Primary Reviewer only for studies reviewed under expedited review procedures

• VA Central IRB Co-Chair reviews and signs all approval letters for new PI Applications

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VA Central IRB Review Model – 7 Steps

3a - Local Site Review VA Central IRB staff provide a

copy of the approved PI/SC application to sites along with the VA Central IRB determination

Sites have up to 15-days to submit comments for consideration by the VA Central IRB

3b - Submission of ApplicationsLocal Site Investigators complete the

LSI Application for their siteAll site applications must be reviewed

and submitted through PI/SC unless PI/SC indicates LSIs can submit directly to VA Central IRB

Note: Local Review is not performed by local IRB

Step 3 - Local Site Review and Submission of Local Site Investigator Applications

Note: These two functions can take place simultaneously

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VA Central IRB Review Model – 7 Steps Step 4 – Review of Local Site Comments and

Local Site Investigator ApplicationsStep 4a – The VA Central IRB reviews local

comments and may do one of the following:

• Refer comments to PI• Require changes in PI and/or LSI Applications• Administratively respond to comments

Step 4b – Review Local Site Investigator Applications

• Include modifications from step 4a if applicable

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VA Central IRB Review Model – 7 Steps Step 5 – PI and LSI Submit Revisions as

applicable• PI can submit answers to questions,

clarifications, or a PI amendment for approval• LSIs submit revisions to their LSI Application

Step 6 – VA Central IRB Makes Final Approval Decision on LSI Application

• Approved documents made available on VA Central IRB Secure SharePoint system

• E-mail sent to PI, LSI, and VA Central IRB Liaison

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VA Central IRB Review Model – 7 Steps Step 7 – Local Site Final Approval• Local Site reviews and approves study in

accordance with local policies and procedures (i.e., R&D Committee approval)

• At local sites, approved application package consists of approved PI Application and the approved LSI Application

Note: A study cannot begin at any given local facility until the PI and, if applicable, the LSI Application, has been approved by the VA Central IRB and the VA facility has complied with the requirements of VHA Handbook 1200.01

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Amendments and Updates• PI Amendments• Made available to all sites through SharePoint

• Local Site Investigator Amendments/Updates• Specific Site Amendment• Updates based on approved PI Amendments or

change in model field (i.e., room or phone numbers)

• Addition of a Site• Sites added after approval of PI/SC Application

will not get 15-day comment period but still may make comments through local R&D process

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Continuing Review• Continuing Review date is set for overall

study, not for each site• Two step application and submission

process:• LSI submits a report to PI by PI established

deadline• PI/SC submits summary report, along with

copies of all LSI reports• Local Site Applications cannot be

approved, even if no further modifications, until PI Application is approved

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Reportable Events

• VA Central IRB Table of Reporting Requirements

• Specific Reporting forms available on VA Central IRB website

• Reported to VA Central IRB, not local IRB• Separate SharePoint site for uploading

reports

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RCO Audits and Other Local Site Audits or Reports• Submitted at Continuing Review:• Routine Research Compliance Officer (ROC)

audits (informed consent and triennial) if no findings require review by the IRB; MVP exception – Quarterly summary from ORO Central Office

• Submitted immediately (By RCO, PI, LSI)• Any reports of apparent serious noncompliance • Any other issues identified that require IRB

review

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Role of VA Central IRB Administrator• Main Point of Contact Prior to Submission • Maintenance of SOPs and Forms• Supervises VA Central staff• Assists VA Central IRB Co-Chairs with

meeting management and IRB member management

• Maintains website and provides training• Serves as POC for outside audits, site

visits, and annual review of VHA Central Office HRPP

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Role of VA Central IRB Managers• Serve as main point of contact after study

is officially submitted to VA Central IRB and assigned a study number

• Performs administrative review and coordinates all other required reviews, to include local site review

• After initial approval, oversees all other study actions in coordination with Primary Reviewer and other staff processing CRs and SAEs/PDs)

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Roles of Other PRIDE Personnel• Program Administrators• Process SAE/Protocol Deviations • Meeting Logistics to include member travel• IRB Member Training and Appointments• SharePoint and ACCESS system development

and maintenance• Regulatory Analyst• Perform Pre-Reviews, Engagement

Determinations• Advises IRB and study teams on regulatory

issues• Fills in as needed for other staff

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Contact Information

Annette R. Anderson, MSVA Central IRB [email protected] or 202-443-5649

E-mail: [email protected] Free Number: 877-254-3130Website: http://www.research.va.gov/vacentralirb/default.cfm

Note: See next slide for additional contact information.

mailto:[email protected]


http://www.research.va.gov/vacentralirb/default.cfm

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VA Central IRB Managers and Other StaffCurrent VA Central IRB Managers and Regulatory AnalystHector Ramirez [email protected] O’Brien [email protected] Clarke 202-443-5677 [email protected] McGee [email protected] Eckart [email protected] Duche [email protected] Weston [email protected] , ACCESS, MOUs, and Reportable Event ReportingLindsey Martin [email protected] Doruska [email protected]






