VA Central IRB Continuing Review Process and Form Changes - PowerPoint Presentation

1. VA Central IRB Continuing Review Process and Form ChangesMary Eckart, BS, CIP, VA Central IRB Manager Mikaela Myers, MA , VA Central IRB ManagerJessica Kroll, MA, CIP, VA Central IRB Administrator

2. Webinar HousekeepingRecording - 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.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/education/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. Webinar Housekeeping

3. ObjectivesThe 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:Overview of why changes were made Description of significant changes Live demo of new Continuing Review forms What’s next?

4. In 2022 VA Central IRB reviewed just over 1,000 PI and LSI Continuing Review packagesCreate a Continuing Review submission process that fits within IRBNet Revise submission forms for:better usability and improved instructions to facilitate completing the forms and reduce administrative correctionsmore efficient experience for research teams and VA Central IRB reviewersWhy change the Continuing Review process?

5. Reduce duplication of reviews (VA Central IRB and local research reviews) on select contentProvide an easier mechanism for the PI to review, compile and present LSI Continuing Review information in a complete PI Continuing Review packageLead the way for other VA Central IRB process and forms updatesWhy change the Continuing Review process?

6. 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.

7. Form 115aPrincipal Investigator (PI)Form 115bLocal Site Investigator (LSI)Form 115d*New Form*Protocol Deviation LogForm 115e*New Form*Adverse Event LogForm 115c*Discontinued*Alternative documentation of fCOI is no longer be requiredContinuing Review Form Names and Numbers

8. Significant Form ChangesAligned 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 Log115e Adverse Event LogLSIs will compile Deviations and AEs for their sitePI will compile Deviations and AEs from all LSIsDeviations and AEs will no longer be listed in the Continuing Review formsEnrollment by Gender, Race, and Ethnic GroupAdded to the PI Continuing Review application to compile all LSI enrollment by Gender, Race, and Ethnic Group, if collected as part of the protocol

9. Significant Form ChangesStudy Personnel Additions and Removals Removed option to add non-key personnelNon-key personnel additions are managed by the local site, therefore the CIRB will only review key personnel additions via an Amendment packageRemoved option to remove personnelNon-key personnel removals are managed by the local siteKey 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 projectStudy Personnel Obtaining Informed ConsentRemoved requirement to check a box for personnel obtaining informed consentStudy Personnel Training Require attestation from PI or LSI that all personnel are up to date on their local training requirements prior to the submission of a Continuing ReviewRemoved requirement to list HSR training dates for all personnel as this is being managed locally

10. Significant Form ChangesStudy Personnel fCOIRequire 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 ReviewRemoved requirement to upload local facility annual fCOI documentation for personnelThe only fCOI documentation that must be provided for CIRB review is if there is a fCOI management plan for an individual on the projectDiscontinued Form 115c ACOS Assurance of COIStudy Personnel CredentialsRequire attestation from PI or LSI that all personnel are appropriately credentialed at their local facility prior to the submission of a Continuing ReviewRemoved requirement to check a box that each personnel listed are credentialedAmendment ListingsRemoved requirement for PI and LSI to list all amendments submitted in the last reporting period as all amendments are accessible in IRBNet

11. Significant Process ChangesVA Central IRB Review and Determination of LSI Continuing Review PackagesLSI 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 NOTE: All LSI Continuing Reviews will continue to be approved under the PI Continuing Review

12. Live Demo of New Continuing Review FormsFor questions, please use Q&A box and address to “All Panelists.” All Webinars will be recorded and posted within one week.

13. What’s Next?For questions, please use Q&A box and address to “All Panelists.” All Webinars will be recorded and posted within one week.

14. 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. June 14, 2023On 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. August 14, 2023Important Dates

15. 15Self-Willed-01-Multipurpose-02-Efficient-03-Additional VA Central IRB UpdatesAll 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.

16. Questions?

17. Contact Information For general VA Central IRB support, please contact VACentralIRB@va.gov or visit our website at VA Central Institutional Review Board (IRB).Mikaela MyersVA Central IRB Managermikaela.myers@va.govMary EckartVA Central IRB Managermary.eckart@va.govJessica KrollVA Central IRB AdministratorJessica.kroll@va.gov For general VAIRRS support, please contact VAIRRS@va.gov.

18. Thank you for joining!