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ORPP&E Webinar Archive

Date Title Presenter(s)
04/29/2021 A New Process for filing Single IRB Exception applications: Effective May 1, 2021

Topics covered: Requesting single IRB exceptions, single IRB exception applications, single IRB requirement, single IRB mandate, single IRB exception request, cooperative research provisions, collaborative research, 38 CFR 16.114

Don Workman, PhD and C. Karen Jeans, PhD
04/08/2021 VA CIRB New Submission Platform for CSP NSCs, PMs, and NODES Managers

Topics covered: VA Central IRB, VA CIRB, IRBNet, VAIRRS, VA Innovation and Research Review System, CSP, Cooperative Studies Programs, OGC 450 Alt-VA, OGC 450 Alt VA, Financial conflict of interest form, FCOIs, Financial conflicts

Angie Foster, Christie O’Brien, Don Workman, PhD, and Jeff Newcomb
04/01/2021 Launch of the Veterans Health Administration (VHA) Central Research Privacy Board (CRPB)

Topics covered: VHA Central Research Privacy Board, VA Central Research Privacy Board, VA CRPB, Privacy Board, VAIRRS, VA Innovation and Research Review System, IRBNet, HIPAA authorizations, Health Insurance Portability and Accountability Act, VA CRPB Local Site Liaison (LSL)

Michelle Christiano, C. Karen Jeans, PhD
03/25/2021 Reimbursables, Expense Transfers and Other Fun Stuff

Topics covered: Finance, Dunlow Musings, Expenditure Transfers, EW, Reimbursables, Redistribution of Funds, Billing, University Bills

Allen Dunlow, Antonio J. Laracuente, Kari Points
03/24/2021 Enterprise Research Data Security Plan (ERDSP) Role-Based Training for Principal Investigators/Institutional Review Board (IRB)/Research & Development (R&D) Committee Stakeholders

Topics covered: ERDSP toolset, Enterprise Research Data Security Plan, ISSOs, Research Support Division, RSD, Information Security Officers, Information Systems Security Officers, ISOs, VA mobile devices, mobile applications, Research Scientific Computing Devices

Terry Peters, Carol Johnson, DuJuan Williams
03/03/2021 VA Central IRB Researcher and Study Team Training

Topics covered: IRB Net, IRBNet Administrator, VA Central IRB Site Liaison, VA CIRB Site Liaison, VAIRRS, CIRB SharePoint, Share Point, VA CIRB, VA Central IRB, IRBNet Gatekeeper, VA CIRB Submissions

Angela Foster, Christine O’Brien, Lindsey Martin, Don E. Workman, Ph.D.
03/02/2021 VA Central IRB Site Liaison and IRBNet Administrator Training

Topics covered: IRB Net, IRBNet Administrator, VA Central IRB Site Liaison, VA CIRB Site Liaison, VAIRRS, CIRB SharePoint, Share Point, VA CIRB, VA Central IRB, IRBNet Gatekeeper, VA CIRB Submissions

Angela Foster, Christine O’Brien, Lindsey Martin, Don E. Workman, Ph.D.
02/25/2021 VA Research Budget Management Webinar (Part 2)

Topics covered: Allocations, distributions, pink sheet, RAFT, SOA, Status of Allowance, AACS, Automated Allotment Control System, FMS, Financial Management System, IFCAP/VISTA, VISTA/IFCAP, Expenditures, Appropriated Funds, Dunlow Updates, Fund Control Points, FCPs, Correct Costing, Obligations, Obligated, Committed, Government Purchase Card, GPC, 1358 document

Erin Olson, Jamece Petteway, Renee Chartrand, Tabitha Randall, Tony Laracuente, Allen Dunlow
02/24/2021 ORD Policy Updates - Technical Amendments to VHA Directives 1200.01, 1200.05, and 1200.08

Topics covered: VHA Directive 1200.05, VHA Directive 1200.01, VHA Directive 1200.08, technical amendments, financial conflict of interests, FCOIs, Financial Conflict of Interest Committees , OGE Form 450-Alt VA, OGE Form 450-Alternative VA, MTAs, material transfer agreements, ERDSP, Enterprise Research Data Security Plan, ISSO Reviews, PO Reviews, Information Security Officers, Information Systems Security Officers, Privacy Officers, VA Form 10-250, EUA, Emergency Use Authorization, discretionary hold, expanded access protocols, designated reviews, continuing reviews, IBCs, Institutional Biosafety Committees, SRS liaison member, Subcommittee on Research Safety, R&DC, R&D Committee, Research and Development Committee

C. Karen Jeans, PhD
02/18/2021 VA Research Budget Management - Part 1

Topics covered: Budgets, research appropriations, carryovers, carry overs, carry-overs, finances, funding, CFO, annual operations plan, rescission, GPF, general post funds, CC101 funds, cost center 101 funds, RDIS annual reports, ePromise, cost transfers, bills of collection, bill of collection, RAFT, VISTA, AACS, WinRMS JRMS

Tony Laracuente, Allen Dunlow, and Kari Points
02/02/2021 New Year, New Platform - Help Make Sure it Works

Topics covered: ORD searchable FAQs, ORPP&E toolkits, sample templates, ORD policy and guidance webpage, ORD human policy and guidance webpage

Soundia A. Duche, MA, MS
11/10/2020 Introduction to Advarra and CIRBI System Demo for local VA Facility POs and ISSOs

Topics covered: Advarra, Commercial IRB, Cooperative Research Provision, Single IRB, Information Security, ISSO, PO, Privacy Officer, CIRBI

Kathleen (Rankin) Dietrich and Betsy Casillo
10/29/2020 Introduction to WCG IRB and IRB Submission Process via IRBNet for local VA Facility POs and ISSOs

Topics covered: WCG, WIRB, Western IRB, Commercial IRB, Cooperative Research Provision, Single IRB, Information Security, ISSO, PO, Privacy Officer, IRB Net, IRBNet, IRB Review Submission Form

Christopher Gennai, CIP, Carmen Thompson, CIP, David Forster, JD, MA, CIP, Owen Bean
10/22/2020 R&D Committee Workshop: Review and Approval of Non-Veterans in VA Research

Topics covered: Non-Veterans, non Veterans, notice of privacy practices, NOPP, research related injury, research related injuries, RIIs, R&D Committee, RDC, R&DC, Research and Development Committee, designated reviews, medical record

Molly Klote, MD
10/16/2020 VA ORD/Operation Warp Speed/NIAID Collaboration: ACTIV-2 Study Overview, Registration and Activation

Topics covered: ACTIV-2, operation warp speed, NIAID, COVID-19 therapeutics, coronavirus, OWS, Sars-Cov-2, ACTIV studies, monoclonal antibodies,, Advarra

Victoria Davey, PhD, MPH; H. Clifford Lane, MD; Janet Woodcock, MD; David (Davey) M. Smith, MD, MAS, FACP, FIDSA; Donna Kostandy; Cristin Harrington; Rhonda Henry
10/15/2020 ORD COVID-19 Research Update for VHA Partners

Topics covered: COVID-19 research registry, coronavirus, Sars-cov-2, operation warp speed, OWS, ACTIV, vaccine trials, ensemble, janssen vaccine trials, therapeutics, master protocols, adaptive protocols, VAIRRS, CTMS, clinical trials management system, Power BI, VAEDA, VA Cures program, HITCH, VA cures-1, CSP 2028, EPIC3, MVP, million veteran program, VA national biospecimen repository, VA national data repository, VA-ORD National Biospecimen and Data Repository, LIMS

Carolyn Clancy, MD; Rachel Ramoni, DMD, ScD; Grant Huang, MPH, PhD; Victoria Davey, PhD, MPH; Molly Klote, MD; Terri Gleason, PhD; David Atkins, MD, MPH; Sumitra Muralidhar, PhD; Holly Krull, PhD; Tricia Dorn, PhD
10/14/2020 Janssen Ensemble Trial: Lessons Learned from the Site Initiation Visit

Topics covered: Jannssen, COVID-19, coronavirus, ensemble, clinical trial, clinical study, johnson and johnson, johnson & johnson, J&J

Anastasia Krajec, RN, Lisa R. Young, PharmD, BCIDP
10/06/2020 Cybersecurity Process for Connecting VA Research Scientific Computing Devices

Topics covered: Research Support Division, RSD, RSCDs, Research Scientific Computing Devices, ERA, Enterprise Risk Analysis, ServiceNow, Service Now, SNOW, RSCD Vendor Workbook, Network Topology Diagram, ERAR, RIDE, Research VLAN

Kevin Essary, Kirsten Chirea, John Fiorino
09/23/2020 VAIRRS How-to Series 1: Tracking studies that do not require Continuing Review

Topics covered: VAIRRS, IRBNet Reports, IRB Net, IRB Continuing Reviews, R&D Committee Continuing Reviews, Tracking studies, lapse in IRB approval, approval lapse, lapse in approval

Angela Foster, Soundia Duche, MA, MS, Jennifer Ordman, MPH
09/10/2020 ORD Research Updates: COVID-19 & Mental Health

Topics covered: COVID, mental health, HSRD, CSRD, RR&D, MH, Inflammatory, COV, caring, contacts, suicide, depression, PTSD, psychosis, REAP, anxiety

David Atkins, MD, MPH; Terri Gleason, PhD; Karen Lohmann Siegel, PT, MA; Bryann DeBeer, PhD, Michael Green, PhD; Jennifer Loftis, PhD; Alan Teo, MD, MS
09/03/2020 NIAID/INSIGHT: ACTIV-3 (INSIGHT 014): Site Registration and Activation - Details of Onboarding Process for VA Medical Centers

Topics covered: ACTIV, COVID, INSIGHT, CSP, OWS, Warp, NIAID, TICO, ICC, SARS, passive immunity, advarra, remdisivir

Victoria Davey, PhD, MPH, Cristin Harrington, Michael Vjecha, MD, Adriana Sanchez, MS, Virginia Kan, MD
08/27/2020 Investigational Drugs in VA: Expanded Access Use, Emergency Use Authorizations, and Use under the Right to Try Law

Topics covered: Expanded Access, EAP, Emergency Use, EUA, Right to Try, RTT, FDA, Mayo, COVID, Coronavirus, Investigational, IND, experimental, compassionate, 1108.04, CCP, convalescent, plasma

Karen Jeans, PhD, CCRN, CIP
07/28/2020 VA's Efforts in the National COVID-19 Clinical Trials on Vaccines and Therapeutics

Topics covered: COVID, Warp speed, OWS, ACTIV, Trial, Moderna, Janssen, Astra-zeneca, Coronavirus, Advarra, WIRB, IBC, Biosafety, PREP, HITCH, CURES

Rachel Ramoni, DMD, ScD; Tom O'Toole, MD; Grant Huang, MPH, PhD; Victoria Davey, PhD, MPH; Molly Klote, MD; Terri Gleason, PhD
07/15/2020 R&D Committee Workshop Series: R&DC Review of the Facility Research Program

Topics covered: Quality, Minutes, Communication, VAIRRS, Metrics, CSP, IRBNet, Insight, Reports, Dashboards

Soundia Duche, MA, MS; Nicholas McCray; Amy Burns, JD, OTR/L; Paska Permana, PhD; Angela Foster
06/18/2020 Facilitating Conduct of Remote Monitoring for Clinical Trials: Key Considerations for VA Researchers

Topics covered: Monitoring, Remote, WebEx, Clinical Trial, HIPAA, Consent, Record, Screen sharing

Karen Jeans, PhD; Paska Permana, PhD; Kimberly Owens, MPH, CCRP
06/04/2020 Process to Resume Research at VA Facilities

Topics covered: Risk, assessment, Animal, In-person, Resume, Administrative hold, COVID, PPE, Facility Sign off, Funded, CIRB, Algorithm, Social distancing, Challenges

Rachel Ramoni, DMD, ScD; Molly Klote, MD; Mike Fallon, PhD, DVM; Sam Aguayo, MD; Holly Henry; Tony Laracuente; Gerhard Schulteis, PhD; Carl Grunfeld, MD, PhD
06/03/2020 R&D Committee Workshop Series: RDC Review of Amendments and Continuing Review

Topics covered: R&D Committee, RDC, Research and Development, Amendment, Continuing Review, Non-Veteran, Exempt, FAQ, Designated Review, Lapse

Soundia Duche, MA, MS; Carole Palumbo, PhD; Mieke Verfaellie, PhD; Douglas Miller, MPA
05/28/2020 VA ORD Efforts Establishing a COVID-19 Biorepository Network

Topics covered: COVID, Biorepository, Tissue, Bank, Repository, Sweep, Sample

Holly Krull, PhD; Jason Wertheim, MD, PhD; Richard Dennis, PhD; Abhinav Diwan, MD; Carey Shive, PhD; Emerson Padiernos, ANP-BC, CRNP; John Harley, MD, PhD; Vincent Marconi, MD; Saiju Pyarajan, PhD; Victoria Davey, PhD, MPH
05/04/2020 Spring Research Town Hall

Topics covered: RSD,E RDSP, RCAP, RSCD, Privacy, 10-250, ICF, HIPAA, Waiver, RCO, Audit, 1058.01, 1058.03, Site visit, COVID, ORO, FDC, Consent, Plasma, VAIRRS, CIRB, VA Central IRB, Facility Director Certification

Karen Jeans, PhD; Kristina Borror, PhD; Stephania Griffin, JD, RHIA; DuJuan Williams
04/30/2020 Implementation of The Mayo Clinic Expanded Access Protocol: Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

Topics covered: Mayo, Plasma, EAP, Expanded Access, COVID, iMed, Consent

C. Karen Jeans, PhD; Kimberly Owens, MPH, CCRP; Paul Tompkins
04/29/2020 Impact on Research Field Operations from COVID-19: Status Report and Ways Forward

Topics covered: Commercial IRB, VAIRRS, Animal, Lab, Biorepository, biospecimen

Rachel Ramoni, DMD, ScD; Tony Laracuente; Marisue Cody, PhD; Mitch Mirkin; Allen Dunlow; Miriam Smyth, PhD; Karen Jeans, PhD, RN; Mike Fallon, PhD, DVM; Holly Krull, PhD; Amanda Hunt, PhD; Kari Points
04/15/2020 The Mayo Clinic Expanded Access Protocol: Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

Topics covered: Expanded Access, COVID, Plasma, Mayo, Antibody, Blood, Red Cross

Molly Klote, MD; C. Karen Jeans, PhD
04/09/2020 R&D Committee Workshop Series: Initial Review and Approval of Exempt Research (Part 2) - Capstone Case

Topics covered: Exempt, R&D,RDC, IRB, Limited IRB Review, Non-Veterans, Determination, Designated Review

Soundia Duche, MA, MS
04/07/2020 Update on ORD-Coordinated Research on SARS-CoV-2-COVID-19

Topics covered: COVID, Clinical trial, Chloroquine, Expanded Access, BARDA, Commercial IRB, CIRB, NIAID, EPICC, Program Announcement, ESP, MVP, BLRD,CSRD,HSRD,RRD

Rachel Ramoni, DMD, ScD; Wendy Tenhula, PhD; Grant Huang, MPH, PhD; Victoria Davey, PhD, MPH; Molly Klote, MD; ORD Research Service Directors
04/02/2020 Human Subject Protections Issues Related to COVID-19

Topics covered: COVID, Commercial IRB, Expanded Access, Designated Review, Informed Consent, HIPAA, Electronic, Cooperative, Amendment, Hazard, Change

Karen Jeans, PhD
03/26/2020 ACOS/AO Education Series: Research Cybersecurity Awareness

Topics covered: ACOS/AO Education Series: Research Cybersecurity Awareness

Carol Johnson; DuJuan Williams; Terry Taylor; Terry Peters
03/20/2020 Enterprise Research Data Security Plan (ERDSP) Training for the Implementation of VAIRRS

Topics covered: ISSO, ISO, Information, ERDSP, Security, VAIRRS, Cybersecurity, Data, Application, Device

Terry Peters and Kenneth Blagg
03/19/2020 ORD Research Response to COVID-19

Topics covered: COVID-19, Coronavirus, Critical, Remdesivir, Expanded

Rachel Ramoni, DMD, ScD; Grant Huang, MPH, PhD; Molly Klote, MD; Wendy Tenhula, PhD; Victoria Davey, PhD, MPH, RN
03/18/2020 Expanded Access Use of for Investigational Drugs in VA: Focus on COVID-19

Topics covered: Expanded access, Emergency, COVID, Remdesivir, Compassionate Use, Gilead, FDA, IND,Investigational

Karen Jeans, PhD; Stephen Bartlett, RPh, MSPH
03/04/2020 R&D Committee Workshop Series: R&D Committee Common Findings and Reporting under VHA Handbook 1058.01

Topics covered: 1058.01; reporting; SAE; UAP; Noncompliance; tool; exempt; R&D; RDC; R&D; serious adverse event; unanticipated problem; findings; termination; suspension; systemic

Kristina Borror, PhD;Duane Janke, MBA, CHRC, CIM; Christine Fitzgerald, MPH
03/03/2020 VA and the Cooperative Research Provision (Single IRB Requirement): March, 2020 Support Session on VA's Implementation

Topics covered: single IRB; Cooperative Research; exception; reliance; CHNE

Sarah Rule, MPH, CCRP
02/20/2020 ACOS/AO Education Series: Records Management Training

Topics covered: ACOS/AO Education Series: Records Management Training

Matthew Staddon; Lucinda Shouse; Karen Jeans
02/19/2020 R&D Committee Workshop Series: Initial Review and Approval of Exempt Research (Part 1)

Topics covered: exempt, limited IRB Review; exempt determination; HIPAA; tools; R&D Committee; CITI; training

Soundia Duche, MA, MS; Dawn Biddulph; Gregory Green, MPH, CIP
01/22/2020 VA's Implementation of the Single IRB “Mandate” in the 2018 Requirements (the Revised Common Rule): What You Need to Know and Do

Topics covered: Cooperative research, Single IRB, Exception, Reliance, IRB Arrangement, Engaged

Karen Jeans, PhD, CCRN, CIP and Sarah Rule, MPH, CCRC
12/19/2019 R&D Committee Workshop Series: Convened Committee Review vs. Designated Review

Topics covered: R&D; R&D Committee; designated review; convened; minutes; tools

Laurie Grevious; Paska Permana, PhD
12/12/2019 ACOS/AO Education Series: BLRD/CSRD Career Development Program - Local Challenges & Solutions

Topics covered: ACOS/AO Education Series: BLRD/CSRD Career Development Program - Local Challenges & Solutions

Terri Gleason
12/11/2019 R&D Committee Workshop Series:  Review and Approval of Research

Topics covered: R&D; feasibility; alignment; R&D Committee; Designated Review; tools

Soundia A. Duche, MA, MS; Christina Bennett
12/10/2019 IRB Chairs Series: Conducting Research in the Inpatient Mental Health Unit

Topics covered: Mental Health; Suicide; Inpatient; Informed Consent; Voluntary Admission; Involuntary Admission; Case Study; Capacity to Consent; Psychiatric Patients; ethics; ethical

Stephen D. Bartlett, RPh, MSPH; Fred Hendler, MD; Ryan Holliday, PhD; Cynthia D. Kerenyi, MAM, CHRC; Soundia Duche, MA, MS
11/07/2019 Differentiating Roles of the Institution vs. IRB

Topics covered: R&D; funding; funded; VAIRRS; 1200.01; 1200.05; Institution; Feasibility; Alignment; Single IRB; VAEDA; Determination Committee

Molly Klote, MD, CIP
10/08/2019 Updates to the VA Central Institutional Review Board (CIRB) Memorandum of Understanding (MOU)

Topics covered: CIRB; Central IRB; MOU; FWA; Panel; SharePoint; liaison; Federal Wide Assurance; Memorandum of Understanding

Annette Anderson, VA CIRB Administrator and Priscilla Craig, Health Science Specialist, ORO
09/26/2019 So the FDA is Coming to Visit Your Site – How Do You Prepare?

Topics covered: FDA; audit; site visit; good clinical practice; ORA; OGCP; BIMO; Bioresearch Monitoring; inspection; 482; 483; RRG; Research Resource Guide

Julia E. Vertrees, PharmD, BCPP
09/20/2019 Director’s Fall 2019 Update

Topics covered: VAIRRS; VAEDA; Smart IRB; 1200.01; 1200.05; Fetal Tissue; Information Security; Privacy; Mental Health; ACT for Veterans

Molly Klote, MD
07/31/2019 Cybersecurity Support for VHA Research

Topics covered: Information Security; ISSO; ISO; research support division

Carol Johnson
06/26/2019 ORPP&E Town Hall: Life under the Revised Common Rule

Topics covered: ORPP&E Town Hall: Life under the Revised Common Rule, Application for Continuing Review: Principal Investigator/Study Chairs, Reviewer Checklist for Continuing Review (PI/SC Application);revised common rule; continuing review; transition

Molly Klote, MD; C. Karen Jeans, PhD, CCRN; Soundia Duche, MA, MS; Kristina Borror, PhD; Priscilla Craig; Annette Anderson, MS; Paska Permana, PhD
06/06/2019 R&D Committee FAQs

Topics covered: VHA Directive 1200.01

Karen Jeans
05/31/2019 The IRB Meeting – A Primer

Topics covered: minutes; quorum; agenda; expedited; tools; voting; actions; controverted issue; letter; notification, IRB

Soundia Duche, Eileen Mc Carthy-Dorsey
03/25/2019 Exempt Research – Categories 1-4

Topics covered: Exempt, limited IRB review, Exempt determination, HIPAA, Continuing Review, R&D Committee, Privacy Rule, Privacy Act, VAEDA, Benign Behavioral Intervention, Secondary Research; privacy rule, privacy act; limited IRB review; benign behavioral

Soundia Duche and Karen Jeans
02/26/2019 VHA Directive 1200.01

Topics covered: 1200.01 , R&D Committee , RDC , R&DC , designated review , external , committee , subcommittee , collaborative research , Iso , ISSO , PO , Privacy Officer , Conflict of Interest , OGE Form 450 , MTA , Agreement; R&D Committee; 1200.01; conflict of interest; discretionary; enforcement; designated review; subcommittee; Information Security; external IRB; collaborative research; material transfer; non-Veteran

Karen Jeans
02/08/2019 A Conversation about human subjects

Topics covered: Director , Update , 1200.01 , 1200.05 , R&D Committee , RDC , R&DC , designated review , external , committee , collaborative research , ACT , non-veterans

Molly Klote
01/25/2019 ORPPE Workshop: Continuing Review Tools

Topics covered: continuing review, lapse, justification, rationale, status report, status update, track; closure

Soundia Duche
01/15/2019 Town Hall Q and A

Topics covered: Privacy; Information Security; HIPAA Authorization; Informed Consent; transition; reconsent; continuing review; children; vulnerable; decision-making; capacity; limited; non-Veterans; certificates of confidentiality; agreement; moon shoot

Molly Klote; C. Karen Jeans; Soundia A. Duche; Kristina Borror; Stephania H. Griffin
01/11/2019 ORPPE Workshop: Informed Consent Tools

Topics covered: informed consent, key information, broad consent, study-specific consent, waiver, HIPAA, element, documentation, screening, recruitment, recruiting, posting, consent form; summary; certificate of confidentiality; documentation; template

Soundia A. Duche
12/18/2018 PART 2 -The Revised Common Rule, Proposed VHA Directive 1200.05, and the IRB: Focus on Significant Changes

Topics covered: revised Common Rule, 2018, pre-2018, compliance date, transition, 1200.05, January 21, rule

C. Karen Jeans, Soundia A. Duche
12/14/2018 ORPPE Workshop: Studies that Must Follow the Revised Common Rule (2018 Requirements)

Topics covered: 2018, pre-2018, rule, January 21, transition, burden reducing, delay, grant, proposal

Petrice B. Longenecker
12/04/2018 12/04/18 Federalwide Assurances, IRB Registration and MOUs for use of External IRBs No Slides Link for Download

Topics covered: assurance, registration, FWA, MOU, IRB, case, poll

Kristina Borror, Priscilla Craig
11/29/2018 The Revised Common Rule, Proposed VHA Directive 1200.05, and the IRB: Focus on Significant Changes

Topics covered: revised Common Rule, 2018, pre-2018, compliance date, transition, 1200.05, January 21, rule

Soundia A. Duche
10/18/2018 Q&A Session on the Revised Common Rule

Topics covered: transition, 1200.05, pre-2018, 2018, 1200.01, informed consent, exempt, limited IRB review, continuing review, FDA, Q&A, questions

Kristina Borror, C. Karen Jeans, Soundia A. Duche
09/19/2018 Revised Common Rule: Changes to Exempt Categories Limited IRB Review

Topics covered: Exempt, limited IRB review, pre-2018, 2018, broad consent, benign behavioral

Kristina Borror
09/18/2018 Overview of the Revised Common Rule and Its Impact on the IRB

Topics covered: 2018, pre-2018, exempt, membership, informed consent, review, assurance, FWA

Soundia A. Duche
07/18/2018 Revised Common Rule: Informed Consent

Topics covered: informed consent, broad consent, clinical trial, posting, pre-2018, 2018, key information, waivers, screening, recruiting, recruitment, elements

Kristina Borror
07/17/2018 Waivers: Common Rule, Privacy Rule, and FDA Regulation

Topics covered: Soundia A. Duche waiver, 2018, pre-2018, FDA, HIPAA, privacy, exception, personal representative, LAR, legally authorized representative, elements, authorization, informed consent, screening, recruiting, recruitment, case, poll, enforcement, discretion

Soundia A. Duche
06/27/2018 Final Rule Issued to Delay for an Additional 6 months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three-Burden Reducing Provisions

Topics covered: January 21, revised common rule, pre-2018, 2018, burden reducing, compliance, grant, contract, research application, transition, research, certification

Petrice B. Longenecker
06/19/2018 Working with the VA Central Institutional Review Board (CIRB): A Dialogue with the IRB

Topics covered: VA CIRB, Central IRB, Chair, Administrator, Application, LSI, PI

Soundia A. Duche
05/15/2018 Expedited Review

Topics covered: Expedited, 2018, pre-2018, minor change, case, poll, compliance, revised common rule, limited IRB review, minimal risk

Soundia A. Duche
04/24/2018 Focus On: Continuing Review

Topics covered: continuing review, pre-2018, 2018, revised common rule, lapse, closure, expedited, approval period, annual, case, poll

Soundia A. Duche
03/20/2018 Secure Messaging for Researchers with Limited Experience Using Secure Messaging

Topics covered: secure message, secure messaging, myhealthevet, email

VHA Office of Connected Care
02/20/2018 Engagement in Human Subjects Research

Topics covered: engagement, case, poll, research, human subject, exempt, engaged, engage

Soundia A. Duche
01/30/2018 Records Management Training

Topics covered: research, records, documentation

Matt Staden, VHA Records Officer
12/19/2017 Certificates of Confidentiality and 21st Century Cures: Part I

Topics covered: CoC, cures, identifiable, informed consent, certificate

Karen Jeans
08/24/2017 Banking/Storing Biospecimens: VA Institutional and IRB Issues and Considerations

Topics covered: Tissue, biospecimens, bank, storage, specimen

Karen Jeans, Soundia A. Duche
06/16/2017 VHA Directive 1200.02: Research Business Operations

Topics covered: contractor, investigator, VA research, extramural funds, JIT, credential, privileging, student, trainee

VHA Office of Research and Development

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