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ORPP&E Webinar Archive

Date Title Presenter(s)
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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