VA Central IRB Continuing Review Process Changes
VA Central IRB is introducing updates to their Continuing Review process and forms. The webinar will discuss the rationale behind the changes, significant modifications made, live demos of new forms, and future steps. Changes aim to enhance usability, reduce administrative errors, streamline the review process, and minimize duplication of reviews.
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VA Central IRB Continuing Review Process and Form Changes Mary Eckart, BS, CIP, VA Central IRB Manager Mary Eckart, BS, CIP, VA Central IRB Manager Mikaela Myers, MA , VA Central IRB Manager Mikaela Myers, MA , VA Central IRB Manager Jessica Kroll, MA, CIP, VA Central IRB Administrator Jessica Kroll, MA, CIP, VA Central IRB Administrator 1
Webinar Housekeeping Webinar Webinar Housekeeping Housekeeping Q&A - Please use the Q&A feature to submit questions. Be sure to send questions to All Panelists Questions will be addressed at the end of the webinar Webinar Archive - Most ORPP&E webinars can be found here: https://www.research.va.gov/programs/orppe/educati on/webinars/archives.cfm Post-Webinar Evaluation Survey - We are grateful to everyone who completes the post-webinar evaluation survey, which will automatically pop up once the webinar is exited. Recording - This session is recorded, and the associated handouts will be available on ORPP&E s Education and Training website within a week after the webinar. Close Captioning - Now available in the new Webex platform. Click the CC button at the bottom left of the Webex screen. Experiencing Sound Issues? - Call in using the number in your Webex chat box or in your registration confirmation email. 2
Objectives The VA Central IRB (CIRB) will share an update on changes and improvements to our Continuing Review process and forms. This webinar will cover the following topics: 1. Overview of why changes were made 2. Description of significant changes 3. Live demo of new Continuing Review forms 4. What s next? 3
Why change the Continuing Review process? In 2022 VA Central IRB reviewed just over 1,000 PI and LSI Continuing Review packages Create a Continuing Review submission process that fits within IRBNet Revise submission forms for: o better usability and improved instructions to facilitate completing the forms and reduce administrative corrections o more efficient experience for research teams and VA Central IRB reviewers 4
Why change the Continuing Review process? Reduce duplication of reviews (VA Central IRB and local research reviews) on select content Provide an easier mechanism for the PI to review, compile and present LSI Continuing Review information in a complete PI Continuing Review package Lead the way for other VA Central IRB process and forms updates 5
Description of Forms and Process Changes For questions, please use Q&A box and address to All Panelists. All Webinars will be recorded and posted within one week. 6
Continuing Review Form Names and Numbers Form 115a Form 115d Form 115b Form 115e Form 115c Principal Investigator (PI) *New Form* Local Site Investigator (LSI) *New Form* *Discontinued* Protocol Deviation Log Adverse Event Log Alternative documentation of fCOI is no longer be required 7
Aligned Principal Investigator (PI) and Local Site Investigator (LSI) Forms All form sections are aligned between the PI and LSI LSI Continuing Review supplement will better support the PI Continuing Review compilation Collection of Protocol Deviations and Adverse Events (AE) New Forms: 115d Protocol Deviation Log 115e Adverse Event Log Significant Form Changes LSIs will compile Deviations and AEs for their site PI will compile Deviations and AEs from all LSIs Deviations and AEs will no longer be listed in the Continuing Review forms Enrollment by Gender, Race, and Ethnic Group Added to the PI Continuing Review application to compile all LSI enrollment by Gender, Race, and Ethnic Group, if collected as part of the protocol
Study Personnel Additions and Removals Removed option to add non-key personnel Non-key personnel additions are managed by the local site, therefore the CIRB will only review key personnel additions via an Amendment package Removed option to remove personnel Non-key personnel removals are managed by the local site Key personnel removals must be submitted via an Amendment package to the CIRB only if it s the PI or LSI to ensure there is appropriate replacement and oversight of the project Significant Form Changes Study Personnel Obtaining Informed Consent Removed requirement to check a box for personnel obtaining informed consent Study Personnel Training Require attestationfrom PI or LSI that all personnel are up to date on their local training requirements prior to the submission of a Continuing Review Removed requirement to list HSR training dates for all personnel as this is being managed locally
Study Personnel fCOI Require attestation from PI or LSI that all personnel serving in an Investigator role have undergone their annual fCOI review prior to the submission of a Continuing Review Removed requirement to upload local facility annual fCOI documentation for personnel The only fCOI documentation that must be provided for CIRB review is if there is a fCOI management plan for an individual on the project Discontinued Form 115c ACOS Assurance of COI Significant Form Changes Study Personnel Credentials Require attestationfrom PI or LSI that all personnel are appropriately credentialed at their local facility prior to the submission of a Continuing Review Removed requirement to check a box that each personnel listed are credentialed Amendment Listings Removed requirement for PI and LSI to list all amendments submitted in the last reporting period as all amendments are accessible in IRBNet
VA Central IRB Review and Determination of LSI Continuing Review Packages LSI Continuing Review Determinations are changing from an expedited review with an approval to an administrative review that will be acknowledged This change will be apparent in the LSI Package Review Details and in the LSI Continuing Review Determination Letter Significant Process Changes NOTE: All LSI Continuing Reviews will continue to be approved under the PI Continuing Review
Live Demo of New Continuing Review Forms For questions, please use Q&A box and address to All Panelists. All Webinars will be recorded and posted within one week. 12
Whats Next? For questions, please use Q&A box and address to All Panelists. All Webinars will be recorded and posted within one week. 13
Important Dates June 14, 2023 New Continuing Review Forms will be uploaded to IRBNet Forms and Templates library (VA Central IRB Administration, Washington, DC Documents for Researchers) and will be available for use. Old forms will temporarily remain in the IRBNet Forms and Templates library to accommodate continuing review submissions that are in progress. Email communication will go out to local site Liaisons and all VA Central IRB researchers. August 14, 2023 On this date the VA Central IRB will only accept the new Continuing Review Forms. Any package submitted with an old form will be returned for the new form to be submitted. A reminder email communication will go out to local site Liaisons and all VA Central IRB researchers.
Additional VA Central IRB Updates All VA Central IRB submissions forms are undergoing updates and will be released to the field now through July 2023. Stay tuned to future communications form the VA Central IRB regarding the release of additional new submission forms and process changes. To prepare for the release of new submission forms, continue to always download forms directly from IRBNet Forms and Templates library (VA Central IRB Administration, Washington, DC Documents for Researchers) when they are needed to ensure the current version is being used and submitted with a package. -01- S e l f - W i l l e d -02- M u l t i p u r p o s e -03- E f f i c i e n t 15
Questions? 16
Contact Information Mary Eckart VA Central IRB Manager mary.eckart@va.gov Mikaela Myers VA Central IRB Manager mikaela.myers@va.gov Jessica Kroll VA Central IRB Administrator Jessica.kroll@va.gov For general VA Central IRB support, please contact VACentralIRB@va.gov or visit our website at VA Central Institutional Review Board (IRB). For general VAIRRS support, please contact VAIRRS@va.gov. 17
