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ORPP&E Webinar Archive

Date Title Presenter(s)
07/31/2019 Cybersecurity Support for VHA Research

Topics covered: Cybersecurity Support for VHA Research

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)

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: 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

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

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, closure

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

Topics covered: townhall, questions, Q&A

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

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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