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VA Central IRB Annette Anderson, MS, CIP VA Central IRB Annette Anderson, MS, CIP

VA Central IRB Annette Anderson, MS, CIP - PowerPoint Presentation

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VA Central IRB Annette Anderson, MS, CIP - PPT Presentation

VA Central IRB Administrator Updated March 27 2017 Purpose of VA Central IRB Primary Purpose Improve human research protections in VA multisite studies by ensuring Consistent expert ethical and scientific review ID: 685225

central irb site local irb central local site review application lsi studies approved investigator study model step 443 202 reviews vha research

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Slide1

VA Central IRB

Annette Anderson, MS, CIPVA Central IRB Administrator

Updated:

March 27, 2017Slide2

Purpose of VA Central IRB

Primary PurposeImprove human research protections in VA multi-site studies by ensuring:Consistent expert ethical and scientific reviewLocal issues are still addressedSecondary PurposeEnhance efficiencies of IRB review in multisite studiesSlide3

VA Central IRB Implementation

Established as part of the VHA Central Office Human Research Protection Program (HRPP) in 2008Institutional Official (IO) is a senior member of VHA LeadershipFirst study reviewed in August 2008 and approved in October 2008As 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 sitesThe VA Central IRB also approves Requests for ExemptionsSlide4

VA Central IRB Composition14

voting members including 2 Co-Chairs and 3 non-scientists1 non-scientist alternate 4 non-voting membersEthicsPrivacy with 1 alternatesInformation Security with 1 alternateLegalAd Hoc Consultants as neededSlide5

VA Central IRB Operations

Staffed by PRIDE1 VA Central IRB Administrator6 VA Central IRB Managers1 Regulatory Analyst2 Program AdministratorsMeetings twice monthly via teleconference; two meetings a year in person in Washington, DCSharePoint used for submitting and distributing documents and tasking ReviewersACCESS and shared drive data base for tracking and storing dataSlide6

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 researchOther designated studies funded by other sources, such as other government entities (DoD), pharmaceutical companies, and research networksCurrently no charge for use of VA Central IRB for VA-funded studies for studies funded by another federal entity.Slide7

Local VA Facility Requirements to Use the VA Central IRB

Local VA Facilities must:Amend Facility Federalwide Assurance to list the VA Central IRB as an IRB of Record; affiliated NPCs must amend FWAs as wellEnter into a Memorandum of Understanding (MOU) with the VHA Central Office and affiliated NPC if applicableDevelop Standard Operating Procedures (SOPs) for using the VA Central IRB as an IRB of RecordAmend affiliate MOU if applicableSlide8

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 IRBAs of March 27, 2017, the VHA Central Office HRPP has MOUs with 104 VA facilities with FWAsSlide9

Local Accountability for ResearchThe 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 ApplicationServe as the Local Site Liaison with the VA Central IRBSlide10

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 determinationAn Exemption from IRB ReviewA Human Subjects Research determination

Administrative Pre-Reviews are also available and highly recommendedSlide11

Application Processes – 2 Types

Principal Investigator (PI) Application – Based on IRB approval criteriaCo-PI and Coordinating Center SupplementsProtocol and other documents (i.e., surveys, scripts, investigator drug brochures)Waiver requestsVulnerable Population SupplementsModel Documents (i.e., informed consent form, recruitment materials, HIPAA Authorization)COI statements from personnel in investigator roles onlyCVs of investigators onlyLocal ACOS/R&D certificationSlide12

Application Processes – 2 Types

Local Site Investigator (LSI) Application –based on and mirrors PI/SC ApplicationLocal study teamLocal resourcesLocal recruitment practicesLocal participant compensation practicesCustomize model documentsAll differences from PI Application must be justifiedSigned by LSI and local ACOS/R certificationSlide13

VA Central IRB Review Model – 7 Steps

Step 1 - PI completes and submits PI ApplicationContact VA Central IRB Administrator prior to completing applicationForms on VA Central IRB websitePI enlists local sites and lists them if knownLocal Conflict of Interest determination if feasiblePI/SC signs form and obtains certification from local ACOS/R&DSlide14

VA Central IRB Review Model – 7 Steps

Step 2 – VA Central IRB reviews PI ApplicationInitial ReviewsAdministrative Information SecurityPrivacyPrimary Reviewer System Primary, Secondary, and Informed Consent Reviewers for studies reviewed at convened IRB MeetingsPrimary Reviewer only for studies reviewed under expedited review proceduresVA Central IRB Co-Chair reviews and signs all approval letters for new PI ApplicationsSlide15

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 determinationSites have up to 15-days to submit comments for consideration by the VA Central IRB3b - 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 simultaneouslySlide16

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 PIRequire changes in PI and/or LSI ApplicationsAdministratively respond to commentsStep 4b – Review Local Site Investigator ApplicationsInclude modifications from step 4a if applicableSlide17

VA Central IRB Review Model – 7 Steps

Step 5 – PI and LSI Submit Revisions as applicablePI can submit answers to questions, clarifications, or a PI amendment for approvalLSIs submit revisions to their LSI ApplicationStep 6 – VA Central IRB Makes Final Approval Decision on LSI ApplicationApproved documents made available on VA Central IRB Secure SharePoint system E-mail sent to PI, LSI, and VA Central IRB LiaisonSlide18

VA Central IRB Review Model – 7 Steps

Step 7 – Local Site Final ApprovalLocal 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 ApplicationNote: 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 1200.01Slide19

Amendments and Updates

PI AmendmentsMade available to all sites through SharePointLocal Site Investigator Amendments/UpdatesSpecific Site AmendmentUpdates based on approved PI Amendments or change in model field (i.e., room or phone numbers)Addition of a SiteSites added after approval of PI/SC Application will not get 15-day comment period but still may make comments through local R&D processSlide20

Continuing Review

Continuing Review date is set for overall study, not for each siteTwo step application and submission process:LSI submits a report to PI by PI established deadlinePI/SC submits summary report, along with copies of all LSI reportsLocal Site Applications cannot be approved, even if no further modifications, until PI Application is approvedSlide21

Reportable Events

VA Central IRB Table of Reporting RequirementsSpecific Reporting forms available on VA Central IRB websiteReported to VA Central IRB, not local IRBSeparate SharePoint site for uploading reports Slide22

RCO Audits and Other Local Site Audits or ReportsSubmitted 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 OfficeSubmitted immediately (By RCO, PI, LSI)Any reports of apparent serious noncompliance Any other issues identified that require IRB reviewSlide23

Role of VA Central IRB AdministratorMain Point of Contact Prior to Submission

Maintenance of SOPs and FormsSupervises VA Central staffAssists VA Central IRB Co-Chairs with meeting management and IRB member managementMaintains website and provides trainingServes as POC for outside audits, site visits, and annual review of VHA Central Office HRPPSlide24

Role of VA Central IRB ManagersServe 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 reviewAfter initial approval, oversees all other study actions in coordination with Primary Reviewer and other staff processing CRs and SAEs/PDs)Slide25

Roles of Other PRIDE Personnel

Program AdministratorsProcess SAE/Protocol Deviations Meeting Logistics to include member travelIRB Member Training and AppointmentsSharePoint and ACCESS system development and maintenanceRegulatory AnalystPerform Pre-Reviews, Engagement DeterminationsAdvises IRB and study teams on regulatory issuesFills in as needed for other staffSlide26

Contact Information

Annette R. Anderson, MSVA Central IRB AdministratorAnnette.anderson3@va.gov or 202-443-5649E-mail: va.central.irb@va.govToll Free Number: 877-254-3130Website: http://www.research.va.gov/vacentralirb/default.cfm

Note: See next slide for additional contact information.Slide27

VA Central IRB Managers and Other Staff

Current VA Central IRB Managers and Regulatory AnalystHector Ramirez 202-443-5656 hector.ramirez@va.govChristie O’Brien 202-443-5660 christie.obrien@va.govKendra Clarke 202-443-5677 kendra.clarke@va.govMichele McGee 202-443-5651 michele.mcgee@va.govMary Eckart Remote

mary.eckart@va.gov

Soundia

Duche 202-443-5658

soundia.duche@va.gov

Rishima Weston 202-443-5642 rishima.weston@va.gov

SharePoint

,

ACCESS, MOUs

, and Reportable Event Reporting

Lindsey Martin 202-443-5653

lindsey.martin2@va.gov

Erica Doruska

Remote

erica.doruska@va.gov