Office of Research & Development |
|
Date | Title | Presenter(s) |
05/13/2022 |
Human Research Protection Updates in VA Research Topics covered: |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E; ORD |
04/28/2022 |
Introduction to ORD’s Biosafety and Biosecurity Program: New Initiatives for VA Facility Topics covered: Purpose: • Describe the purpose of ORD’s Biosafety and Biosecurity Program • Describe current activities regarding data calls supporting the ORD Biosafety and Biosecurity Program • Identify key components of ORD’s Biosafety and Biosecurity assistance visits to VA Facilities • Describe the educational purpose of the “biosafety toolkit” available for use by VA Facilities • Gather perspectives from the field on biosafety and biosecurity priorities |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E; ORD and John Balog, BS, RBP (ABSA) ORD National Biosafety Officer, ORPP&E; |
04/26/2022 |
VAIRRS Dashboards and How to Utilize Facility Data Topics covered: VAIRRS Dashboards and How to Utilize Facility Data |
Angela Foster, Nelson Vasconcelos, and Katrina Young |
04/06/2022 |
ORD Finance Enterprise Initiative Update, ORD Appropriations Structure, Closing FY22 Topics covered: ORD Finance Enterprise Initiative Update, ORD Appropriations Structure, Closing FY22 |
Jason Berlow; Matthew Verna; Antonio Laracuente; Kari Points |
03/31/2022 |
VA Central IRB: Quarterly Webinar Duplicate Project Reconciliation Topics covered: VAIRRS, VA Central IRB: Quarterly Webinar Duplicate Project Reconciliation |
Angela Foster; Don E. Workman; Jeff Newcomb |
03/30/2022 |
Best Practices for Managing Inventory of Research Equipment Topics covered: Best Practices for Managing Inventory of Research Equipment |
Patricia Kassiday |
03/22/2022 |
VAIRRS Ambassador Highlight - VA Boston Health Care System Topics covered: VAIRRS |
Angela Foster, Carole L. Palumbo |
03/03/2022 |
Field Enterprise Research Support Service Contract - Introduction and Rollout Topics covered: |
Antonio Laracuente; Grant Huang; Erica Aulik |
02/28/2022 |
Finance: Lessons Learned from the Sweep and FY22 Guidance Topics covered: finance |
Antonio Laracuente, Matthew Verna, John Verwiel, Jason Berlow |
02/22/2022 |
Central IRB Continuing Review - Best Practices Topics covered: Central IRB Continuing Review - Best Practices, VAIRRS |
Mary A. Eckhart (VHACLE), Angela Foster |
02/09/2022 |
Guidance Regarding the Without Compensation and State Treasury Exceptions to 18 U.S.C. § 209 Topics covered: Guidance Regarding the Without Compensation and State Treasury Exceptions to 18 U.S.C. § 209 |
Karen Jeans, Director of Regulatory Affairs, ORPP&E; Christopher Britt, Attorney, OGC Ethics Specialty Team; Antonio Laracuente, Director Field Operations; Wendy Tenhula, Deputy CRADO |
01/31/2022 |
VAIRRS Monthly Webinar Topics covered: VAIRRS Monthly Webinar |
Dr. Mary (Molly) Klote |
01/13/2022 |
IRBNet 101 for Central IRB Coordinators and Investigators - FY 22 Qtr Topics covered: IRBNet 101 for Central IRB Coordinators and Investigators - FY 22 Qtr |
Don Workman, VA IRB Network Director; Jessica Kroll, VA Central IRB Administrator |
10/14/2021 |
Electronic Documentation of Written Informed Consent Topics covered: iMedConsent Web, DocuSign; Informed consent; Research; HIPAA authorization; electronic/digital signatures |
Paska Permana, PhD, April Primous, Nigel Clarke, MSc; Erica Aulik; Janet Fawcett, PhD |
10/08/2021 |
VHA Regulatory Research Cybersecurity Guidance Request Process & ServiceNow (yourIT) Intake Portal Topics covered: ServiceNow (YourIT) Intake Portal; VA Security Policy; VHA Regulatory Research Cybersecurity Guidance; Cybersecurity; research stakeholder Training; Cybersecurity/Information Policy Guidance; Research Agreement Review |
Carol Johnson - Cybersecurity Subject Matter Expert, OIS-SSS-Research Support Division; Terry Peters - Cybersecurity Subject Matter Expert, OIS-SSS-Research Support Division; DuJuan Williams – Supervisory IT Program Manager, OIS-SSS-Research Support Divis |
10/07/2021 |
IRBNet 101 for Central IRB Coordinators and Investigators - FY 22 Qtr 1 Topics covered: CIRB submission; IRBnet; VAIRRS; Optimization Dashboards; Enrolling in IRBNet; IRBNet Terms |
Angela Foster, VAIRRS Program Manager; Jessica Kroll, VA Central IRB Administrator; Christine O’Brien, VA Central IRB Manager; Don Workman, VA IRB Network Director |
09/28/2021 |
Closing the Year and Opening the Year: FY 21 Expenditure Reports, FY 22 Execution and Expectations Topics covered: Finance, ORD, FY 21 Expenditure Reports, FY 22 Execution, RAFT Expenditure Report, FY 22 Budget |
Antonio Laracuente, Director Field Operations; John Verwiel, Acting Director Finance, ORD; Kari Points, Director Research Operation, Iowa City |
08/26/2021 |
Optimal Workflow Management for Local Research Offices Topics covered: IRBnet, Local Research Offices, CIRB, Local site studies, Data submission, Multi-site studies, Research Office Package, Research protocol, CIRB studies |
Don Workman, PHD, VA IRB Network Director and Owen Bean, IRBnet Director |
08/24/2021 |
Recruitment by Phone Topics covered: Proactive Calling, Recruitment by Phone, CIRB, Research recruitment, Recruitment Materials, VHA Directive 1200.05, VA Subjects, ORD Request Process |
C. Karen Jeans, PhD |
07/27/2021 |
VAIRRS How To Series 3: Insight Reports and Running Macros Focused on Expiration Dates and Continuing Reviews Topics covered: VA Central IRB, VA CIRB, IRBNet, VAIRRS, VA Innovation and Research Review System, Macros, Insight Reports, Expiration Dates, and Continuing Reviews |
Angela Foster, PM/COR, VAIRRS and VAEDA; Nelson Vasconcelos, Senior Management Analyst, Goldschmitt and Associates LLC |
07/26/2021 |
The Press Ganey RN Survey Research Study Topics covered: Press Ganey RN Survey, RN National Database of Nursing Quality Indicator (NDNQI) RN Survey Research Study, Nursing, VA Central IRB, Local IRB, and Limited IRB review |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E; |
06/23/2021 |
Managing and Navigating WinRMS Session 4: Setting up Accounts, Expense Transfers and Split Account Transactions Topics covered: Finance, WinRMS, Budget office, Account expense transfer, Split account transactions, IPAs, Per Diems, Cores |
Erin Olsen, Kari Points, Antonio Laracuente |
06/22/2021 |
Managing and Navigating WinRMS Session 3: How to Manage the Noise in a Download Topics covered: Finance, WinRMS, Budget office, Dual entries, Budget Office adjustments, Payroll and Delegation logs |
Erin Olsen, Kari Points, Antonio Laracuente |
06/16/2021 |
Managing and Navigating WinRMS Session 2: Salary Management Topics covered: Finance, WinRMS, Budget office, Salary Management, Downloading Salaries, Managing Employees, projections, Expenditure Transfers, and Reconciling to FMS |
Jamece Petteway, Kari Points, Antonio Laracuente |
06/15/2021 |
Managing and Navigating WinRMS Session 1: TDAs – Allocations and Distributions Topics covered: Finance, WinRMS, Budget office, Allocations and Distributions |
Tabitha Randall, Kari Points, Antonio Laracuente |
06/10/2021 |
VAIRRS How To Series 2: Getting the Most out of Insight Reports Topics covered: VAIRRS, IRBNet Insight Reports, Macro, Excel |
Nelson Vasconcelos, Angie Foster, Erica Aulik |
05/05/2021 |
Office of Information Security (OIS) Role-based Training for Principal Investigators (PI)/Research & Development (R&D;) Committee/Subcommittee Stakeholders on the Enterprise Research Data Security Plan (ERDSP) Version 2.2 Topics covered: Enterprise Research Data Security Plan, ISSOs, Research Support Division, RSD, Information Security Officers, Information Systems Security Officers, ISOs |
Terry Peters and Carol Johnson |
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 |
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, ACTGnetwork.org, 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, 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, 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, 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, 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; 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: 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 |