Office of Research & Development |
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Date | Title | Presenter(s) |
04/19/2024 |
National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) Website Training Topics covered: Target Audience: VA research teams that support NCI CIRB (e.g., SWOG, Alliance, NRG, & ECOG-ACRIN) trials. Join Nadia Goranova and Megan Blackburn from the National Cancer Institute's Cancer Trials Support Unit (CTSU) for a presentation on the functionality of the CTSU website. This session will highlight website features and show various modes of navigation, including locating all components of a protocol. We will discuss finding regulatory protocol requirements, checking your site's regulatory status, linking providers to your site, and submitting documentation through the Regulatory Submission Portal. Learn tips and tricks, including finding accrual information quickly and customizing your Dashboard so the website components you need are at your fingertips. Discover how the website is integrated and connected to other CTSU applications such as OPEN, DQP, SDP, and DTL. Learn about the numerous resources available on the website and how to find help. |
Stephanie Ferguson, NAVIGATE National Program Manager |
04/09/2024 |
Toxic Exposure Fund (TEF) Budget Execution Topics covered: Target Audience: Field Research Office Budget/Finance Staff ORD Finance will provide guidance to assist sites with transition to TEF appropriation for TEF studies. |
Erin Olson, Budget Analyst |
03/13/2024 |
Monthly Finance Training: FY 24 Contracting Training Topics covered: Objectives: |
Antonio Laracuente, Director of Field Operations |
02/27/2024 |
Monthly Finance Training Series: The Toxic Exposure Fund (TEF) and the ORD TEF Policy Topics covered: |
Dr. Rudy Johnson, Dr. Karen Block, Jason Berlow, Erin Olson, Kari Points |
12/20/2023 |
HRPP Bimonthly Updates in VA Research: December 2023 Topics covered: Objectives: The purpose of this bi-monthly webinar is to update the VA research community on various topics related to human subjects protections. December’s planned topics include:
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Karen Jeans,PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E |
12/19/2023 |
Implementation of VHA Notice 2023-09, Outside Compensation for Performance of VA Research Topics covered: Objectives: The purpose of this webinar is to describe the implementation requirements for the new VHA Notice 2023-09, Outside Compensation for Performance of VA Research which was issued on November 28, 2023 and must be implemented by February 29, 2024. The Notice’s requirements will be discussed with dedicated time for questions from the attendees. |
Tony Laracuente, MBA; Director of Field Operations, ORD & Karen Jeans, PhD, CCRN, CIP; Director Of Regulatory Affairs, ORPP&E |
12/14/2023 |
Finance Monthly Training: Explaining VA Funding Requirements to Principal Investigators Topics covered: Objectives:
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Finance Webinar Team |
12/07/2023 |
Artificial Intelligence (AI) in Research and IRB Review Topics covered: Webinar Objective/Learning Goals:
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Molly Klote, MD, CIP Deputy CRADO for Research, Moderator |
12/05/2023 |
VAIRRS Monthly Webinar: End of Year Updates including New Wizards Topics covered: Objectives: Join the December feature of the VAIRRS Monthly Webinar Series to learn more about the new VAIRRS wizards, expired project notifications, and other important updates. The purpose of the VAIRRS Monthly Webinar Series is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation and Research Review System (VAIRRS). |
VAIRRS Support Team; Angela Foster, Program Manager, Enterprise Research Data Systems, ORPPE |
11/15/2023 |
Understanding CRs and Government Shutdowns Topics covered: Objectives
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Finance Webinar Team |
10/25/2023 |
Finance Monthly Training Series: Open Obligations Topics covered: Objectives:
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Finance Webinar Team |
10/24/2023 |
VAIRRS: VA Central IRB Forms and Process Updates Topics covered: Objectives: The VA Central IRB will be providing an overview of the final release of new project forms and process changes. Additionally, an update will be provided on the Continuing Review process. |
Jessica Kroll, MA, CIP, VA Central IRB Administrator; Don Workman, Ph.D., VA IRB Network Director |
10/05/2023 |
How to use VA Enterprise Cloud for Research Topics covered: Objectives:
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Dr. Siamack Ayandeh Chief Architect, Big Data Science, ORD |
08/31/2023 |
HRPP Bimonthly Updates in VA Research: August 2023 Topics covered: Objectives: The purpose of this bi-monthly webinar is to update the VA research community on various topics related to human subjects protections. August’s planned topics include:
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Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E |
08/30/2023 |
Finance Monthly Training Series: Closing the Year Topics covered: Objectives 1: Understand the requirements closing out prior year and current year |
Finance Webinar Team |
08/17/2023 |
Box/Qualtrics Integration Demonstration and Enterprise Research Topics covered: This webinar will present a high level brief overview of Qualtrics, and then bring awareness to the ORD enterprise license that is available for specific research use cases |
Kary Storms IT Project Manger OIT; Steven Gethard, Solutions Engineer Qualtrics |
08/15/2023 |
VAIRRS Monthly Webinar Series: New Wizards Topics covered: Objective: The purpose of the VAIRRS Monthly Webinar Series is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation and Research Review System (VAIRRS). |
VAIRRS Support Team; Angela Foster, Program Manager, Enterprise Research Data Systems, ORPP&E |
08/01/2023 |
Modifications to the VA Central IRB MOUs Topics covered: Objectives: To review changes that have been made to the IRB Reliance Agreement (MOU) between the VHA Central Office and the Facilities utilizing the VA Central IRB, and to provide time for questions from the Field. |
Don E. Workman, PhD, VA IRB Network Director |
07/25/2023 |
VA Institutional Biosafety Committee Key Administrative Document Requirements Topics covered: Purpose: |
John Balog, BS, RBP ORD National Research Biosafety Officer |
07/19/2023 |
Finance Monthly Training Series: Introduction to ORD Financial Management Resources Topics covered: Objective:
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Finance Webinar Team |
06/28/2023 |
HRPP Bimonthly Updates in VA Research: June 2023 Topics covered: Purpose: The purpose of this webinar is to update the VA research community on various topics related to human subjects protections, including:
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Karen Jeans, PhD, CCRN, CIP; Dir. of Regulatory Affairs |
06/28/2023 |
Finance Monthly Training Series: Cost Transfers Topics covered: Objectives: 1. Understand the key policies governing expense transfers government wide and within VA 2. Understand when an expense transfer is required and not required 3. Understand how to request a cost transfer for the following categories: a. Current Year to Prior Year Cost Transfers b. Research Program to Research Program c. Research Appropriation to/from Medical Center Appropriation d. Research Appropriation to Reimbursable 0161R1 or 0161X2 |
VA Finance Team |
06/27/2023 |
VAIRRS Monthly Webinar Series: VA Central IRB Updates on New Processes and Forms Topics covered: Objective: |
Jessica Kroll, MA, CIP |
06/14/2023 |
ORD FIND Pro Demonstration Topics covered: Note: There are two dates for this webinar. They will be the same presentation but there will be two opportunities to tune in. Purpose:
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Erica Aulik, MEd, Program Specialist; Stephen Henshaw, Senior Consultant, Contractor Support to Office of Research and Development; Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs |
06/13/2023 |
VAIRRS: VA Central IRB Continuing Review Process and Form Changes Topics covered: Objective: The purpose of this webinar is to provide an overview of changes to the PS/SC and LSI continuing review forms and process. |
Jessica Kroll, MA, CIP |
06/13/2023 |
ORD FIND Pro Demonstration Topics covered: Note: There are two dates for this webinar. They will be the same presentation but there will be two opportunities to tune in. Purpose:
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Erica Aulik, MEd, Program Specialist; Stephen Henshaw, Senior Consultant, Contractor Support to Office of Research and Development; Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs |
05/30/2023 |
VAIRRS Monthly Webinar Series: Data Availability Topics covered: Objective/Purpose: Join the May feature of the VAIRRS data integrity webinar series to learn more about the VAIRRS data platforms, presented by the VAIRRS Support Team and ORPP&E Program Manager Angela Foster. The purpose of the VAIRRS Monthly Webinar Series is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation and Research Review System (VAIRRS). |
VAIRRS Support Team; Angela Foster, Program Manager, Enterprise Research Data Systems, Office of Research Protections, Policy, and Education (ORPP&E) |
05/17/2023 |
Finance Monthly Training Series: 2023 Administrative Officers for Research Topics covered: Objectives:
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VA Finance Team |
05/16/2023 |
VA ORD Centers: Next Steps to Engage Center Leaders in the ORD Research Enterprise Transformation Topics covered: Learning Objectives: Hear from ORD leaders on the Research Enterprise Transformation, Learn how ORD is seeking to better understand the critical role of VA ORD Centers in the research enterprise, and Get informed on ORD’s next steps to engage you and your staff in the Field in this effort |
Grant Huang, Molly Klote, Chris Bever (co-facilitators) |
05/11/2023 |
TRM Tagging and the ORD IT Service Catalog Webinar Topics covered: Objective: |
Joseph Holston & Karla Keelean |
04/19/2023 |
Checklist and Tools for Submission of Informed Consent Documents to ORD-approved Commercial IRBs Topics covered: Purpose:The purpose of this webinar is to review revised and new ORD tools and processes to facilitate informed consent submissions to ORD-approved commercial IRBs, including review of the following located on VA’s webpage for use of Commercial IRBs: https://www.research.va.gov/programs/orppe/irb_relationships.cfm: - Specific and Selected 2018 Common Rule Informed Consent Requirements When Using an Independent-Commercial IRB - VA HIPAA Authorization Requirements When Using an Independent (Commercial) IRB - Checklist for VA Facilities Using Independent Commercial IRBs-ICDs and Combined ICD-HIPAA Authorizations - VA Facility Endorsement Letter Template for Commercial IRB Submission |
C. Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E |
04/11/2023 |
VAIRRS Monthly Webinar Series: How to Properly Utilize the Research Admin Workspace in IRBNet Topics covered: Objectives: VAIRRS is launching a new data integrity se-ries to the monthly webinar schedule. The first installment will focus on how researchers and administrators properly utilize the research admin workspace in IRBNet. |
Angela Foster, ORPP&E Program Manager |
04/05/2023 |
HRPP Webinar Series : Bimonthly Updates in VA Research Topics covered: Objectives: The purpose of this webinar is to update the VA research community on various topics related to human subjects protections, including the following March topics:
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C. Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs |
03/21/2023 |
BOX-Qualtrics Integration Training (Part 2) Topics covered: Purpose:
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VA BOX-Qualtrics Team |
03/15/2023 |
Finance Monthly Training Series: The Reimbursable Process Topics covered: Objectives:
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Jason Berlow, Management Analyst, Finance & Antonio Laracuente, Director, Field Operations |
02/28/2023 |
VAIRRS Monthly Webinar Series: VA Central IRB Quality Assurance Process in IRBNet Topics covered: Objective: |
Jessica Kroll, MA, CIP |
02/15/2023 |
Finance Monthly Training Series: Appropriations Law Topics covered: Objectives:
Presenter: Jason Berlow, Management Analyst, Finance & Antonio Laracuente, Director, Field Operations |
Jason Berlow, Management Analyst, Finance & Antonio Laracuente, Director, Field Operations |
01/24/2023 |
VAIRRS Monthly Webinar Series: VAIRRS University Walk-Through Topics covered: Purpose: Join the VAIRRS January webinar to learn more about VAIRRS University, a revised training library designed to promote self-education and independent learning. This new platform will allow VA research employees to easily locate and access VAIRRS-specific training resources. The purpose of VAIRRS Monthly Webinar is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation and Research Review System (VAIRRS). |
Angela Foster, ORPP&E Program Manager |
01/19/2023 |
BOX-Qualtrics Integration Training Topics covered: Purpose:
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VA BOX-Qualtrics Teams |
01/18/2023 |
Finance Monthly Training Series: Understanding the flow of Funding, Obligations, and Common Financial Reports Topics covered: Purpose:
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Diane Murphy, Budget Analyst, Finance; Kari Points, AO-Research, Iowa City VAMC; Jason Berlow, Management Analyst, Finance |
01/17/2023 |
Processing WOCs and IPA under the Guidance from HR Topics covered: Purpose:
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Antonio Laracuente, Kurt Lichtenberg, & Karen Jeans |
12/15/2022 |
Finance Monthly Training Series: Contracting Basics-Working with RPO East Topics covered:
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Seth J. Custer, Division Chief, VHA R&D Contracting Division |
12/14/2022 |
HRPP Bimonthly Updates in VA Research: December 2022 Topics covered: The purpose of this webinar is to update the VA research community on various topics related to human subjects protections, including:
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Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs |
12/07/2022 |
Understanding and Balancing the Status of Allowance Topics covered:
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Tony Laracuente and Kari Points |
11/28/2022 |
VAIRRS Monthly Webinar Series: VAIRRS Ambassador Highlight - VA Greater Los Angeles Healthcare System Topics covered: Join the VAIRRS November webinar to learn about the September Ambassador, VA Greater Los Angeles Healthcare System, their experience with VAIRRS and tips for the field. |
Cody Knight, IRBNet/iMedRIS System Admin & Quantitative Core Team, VA Greater Los Angeles Healthcare System (VISN 22) - Medical Research Service |
11/09/2022 |
Finance Monthly Training Series: Finding, Reviewing and Executing your Budget Allocations Topics covered: Objectives:
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Jason Berlow, Management Analyst, Finance |
11/02/2022 |
VA DocuSign – ORD TPOXX Expanded Access Program Tool Aid: Demonstration and Discussion of the VA DocuSignTool Topics covered: Apply the TPOXX Job Aid to assist clinicians use VA Docusign for obtaining informed consent and HIPAA authorization in the TPOXX expanded access program. |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs |
10/19/2022 |
Finance Monthly Training Series: IAAs and Reimbursables Topics covered: |
Jason Berlow, Management Analyst, Finance; Laracuente, Antonio, Director, Field Operations; Kari Points, AO-Research, Iowa City VAMC; John Verwiel, Deputy Director of Finance |
10/18/2022 |
Conflict of Interest (COI) Module for Investigators and Committee Members Topics covered: VAIRRS |
Angela Foster, ORPP&E Program Manager |
10/06/2022 |
Best Practices on Remediation of Technical Reference Model (TRM) Unapproved Software on VA Networks Topics covered: |
Carol Johnson Program Lead, Office of Information Security (OIS), Specialized Device Cybersecurity Department (SDCD) Cybersecurity Review, Enterprise Awareness, Training & Education (CREATE) |
10/05/2022 |
Updates on the new CC 101 Model Topics covered: |
Jason Berlow, Management Analyst, Finance; Laracuente, Antonio, D Kari Points, AO-Research, Iowa City VAMC; John Verwiel, Deputy Director of Finance |
09/28/2022 |
Biosafety & Biosecurity Toolkit Demo Topics covered: |
Natasha Griffith, Totally Joined For Achieving Collaborative Techniques |
09/27/2022 |
Institutional Biosafety Committee (IBC) Roles and Responsibilities to Support VA Research Involving Recombinant or Synthetic Nucleic Acids Topics covered: |
John Balog, BS, RBP (ABSA), ORD National Biosafety Officer |
09/21/2022 |
VA Electronic Determination Aid (VAEDA) Full Launch Topics covered: VAEDA, VAIRRS |
Dr. Molly Klote; Dr. Jeffrey Ferraro, PhD, MSc; Don Workman, PhD; Angela Foster |
09/20/2022 |
IRBNet Basics for Investigators Topics covered: VAIRRS |
VAIRRS Support Team, Angela Foster |
09/14/2022 |
Human Research Protection Updates in VA Research Topics covered: |
C. Karen. Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E |
08/25/2022 |
Finance Monthly Training Series: Research Admin 101 Topics covered: finance |
Antonio Laracuente, Director of Field Operations; Kari Points, Research AO, Iowa City VAMC |
08/23/2022 |
Submission Process for Multiple Co-PIs (VAIRRS) Topics covered: VAIRRS |
Angela Foster & Jessica Kroll |
07/29/2022 |
IRB Reliance on the CDC IRB and Implementation of the Expanded Access Program: “Expanded Access IND Protocol: Use of Tecovirimat (TPOXX®) for Treatment of Human Orthopoxvirus Infections” Topics covered: |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E |
07/28/2022 |
Finance Monthly Training Series: Closing the Fiscal Year and End of Year Reporting Topics covered: |
John Verwiel, Deputy Director Office of Finance; Jason Berlow, Mgmt and program analyst, Office of Finance |
07/27/2022 |
Bi-Monthly Updates in Human Research Protection Topics covered: Human Research Protection |
Karen Jeans, PhD, CCRN, CIP; Director of Regulatory Affairs, ORPP&E; ORD |
07/21/2022 |
ORD Organizational Alignment Field Webinar Topics covered: |
Rachel Ramoni – CRADO; Grant Huang – DCRADO; Molly Klote – DCRADO; Tony Laracuente – Director of Field Operations; Chris Bever – Director BLR&D; Jason Berlow – Management and Program Analyst ORD Department of Finance |
07/19/2022 |
VAIRRS Ambassador Highlight: William S. Middleton Memorial Veterans Hospital Topics covered: The purpose of VAIRRS Monthly Webinar is to provide expert advice, training, demonstration, and/or direction to the VA research community regarding the various topics around the VA Innovation Research Review System (VAIRRS). |
Angela Foster, Aaron Heneghan, Karen D. Hoffman, Jamie M. Swanlund |
06/29/2022 |
ORD Document Finder Tool Introduction and Orientation Topics covered: ORD Document Finder Tool Introduction and Orientation |
Erica Aulik & Matthew Zelt |
06/28/2022 |
Best Practices on How to Track and Locate Approved Documents in IRBNet Topics covered: vairrs |
Daniel P. Edwards & Angela Foster |
06/23/2022 |
Finance Monthly Training Series: Using VSSC and reading the Status of Allowance (SOA) Topics covered: Navigating VSSC and downloading SOAs; Obligations, commitments, and what is recorded in FMS; Using SOAs to troubleshoot |
Kari Points, Research AO, Iowa City VAMC; Antonio Laracuente, Director of Field Operations |
06/16/2022 |
Foundations of a VA Biomedical Research Laboratory Biorisk Management Program Topics covered: Purpose: To identify and define common terms associated with a research biomedical laboratory research program, To inform stakeholders on key basic tasks needed to establish and sustain a biorisk management program in supporting VA biomedical research laboratory operations, Foundations of a VA Biomedical Research Laboratory Biorisk Management Program |
John Balog |
05/26/2022 |
Finance Monthly Training Series: Managing Salaries at your VA Research Office Topics covered: Pay period analysis and projecting payroll; Rejects and troubleshooting; Managing cost-transfers between programs and fiscal years; Supporting documentation: draft SOP for salary management |
Kari Points, Research AO, Iowa City VAMC; Antonio Laracuente, Director of Field Operations |
05/24/2022 |
IRBNet Basics for Investigators Topics covered: VAIRRS Monthly Webinar – IRBNet Basics for Investigators |
Angela Foster |
05/19/2022 |
VHA Research Law Explorer Topics covered: VHA Research Law Explorer |
Mike Wiley - Analyst at Rios Partners; Carrie Welton - Senior Consultant at Rios Partners; Matt Razzano - Consultant at Rios Partners’ Don Workman - VA IRB Network Director |
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 |
03/03/2022 |
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. Eckart (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 Kickoff: Feasibility/Alignment & Scientific Review Topics covered: VAIRRS Monthly Webinar Kickoff: Feasibility/Alignment & Scientific Review |
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 |