New IRB Member Review Walkthrough A practical walkthrough

New IRB Member Review Walkthrough A practical walkthrough of how to review agenda items using Toolkit

Contents • IEP Transition Refresher • Timeline • Committee structure/schedule • Toolkit review: Worksheets (HRP-314) vs Checklists (HRP-401) • Meeting Process Updates • IRB Website Updates • ARROW live Walkthrough • Preparing for a meeting • Initial Review • Change of protocol • Continuing review Committee meeting review

Timeline NOW • ARROW updates live • Protocol Based Application and Toolkit checklists/workflows • Website updates live • Researcher access to Toolkit and Investigator Manual • IRBM access to training recordings • Staff Reviews END WEEK of MAY 17 TH (IR, COP) • CRs have already eliminated ”staff review” • REs will continue to have staff reviews for a while • IRBS complete checklists • Agenda item summaries are being done by IRBMs (except for CRs) • CR summaries will be given by IRBS indefinitely MAY • HS panel restructuring • New HS vice-chairs and Panel Administrators officially on board • 5/3 FIRST PANEL MEETING (Panel A) • 5/6 Panel B meeting • IRBS will continue to complete checklists JUNE • MRR board merging and panel restructuring

Committee Structure

Worksheets vs Checklists Worksheets • DO NOT need to be filled out or turned in • Located on main page of new website under ”Toolkit Library” • GUIDES for completing your review • Reference the other toolkit documents that are relevant to your review • HRP-314: Criteria For Approval • Will be emailed prior to each meeting • Highlighted to show areas IRBMs should focus on during meeting discussion • Displayed during meeting • Used for INITIAL REVIEWS primarily Checklists • IRB Staff (IRBS) complete • IRBS will fill out before scheduling item for meeting • IRBS will update (if necessary) and finalize after meeting • Located in ARROW • Also located on new website w/ all check box hide/show options listed • Document all required regulatory criteria for a category • HRP-401 Pre-Review Checklist • Will be completed by IRBS for every initial review • And as necessary for CPs/CRs by IRBS • Supplement Checklists (e. g. vulnerable groups, waivers of consent) • Completed by IRBS as applicable

HRP-401 Pre-Review Checklist • IRBS will fill out prior to scheduling item for a meeting • • • The same checklist is used for all agenda items (IR, COP) Is ALWAYS completed for IRs scheduled for FC review MIGHT be completed for COPs/CRs scheduled for FC review • COPs • HRP-401 will be updated if something in HRP-401 is changing with the amendment and/or if there is something problematic to mention in the NOTES section • CRs • • HRP-401 will be updated ONLY if there is something problematic to mention in the NOTES section IRBS will FINALIZE after meeting review is complete

HRP-401: Pre-Review Checklist Notes • IRs • Short study summary • Important regulatory details • Problematic issues • COPs • Questions/issues to note • “Backfilling” • CRs • Questions/issues to note • “Backfilling” Notes are DELETED by IRBS after each submission is approved

Meeting Process Updates Here's how we are helping to ease the transition. . . Staff Reviews will still be used • Will continue to provide staff reviews for 2 more weeks • IRBMs should use staff reviews to facilitate understanding and use of HRP-314 and HRP-401 • Emailed along with HRP-314 prior to meeting (will NOT go in ARROW) • DO NOT need to be filled out/signed by IRBM or turned back in Staff Reviewers continue to attend meetings • Will continue to attend any panel meeting where they have an agenda item for review • Still a primary resource for members • CR summaries will continue to be given by IRB CR staff reviewer indefinitely • IRBS can assist in agenda item summary if necessary

Meeting Process Updates What is DIFFERENT? IRBMs summarize most agenda items (except CRs) starting MAY 2021 • HS IRB staff will continue to summarize CRs indefinitely Moving to Panel Structure • HS IRB May 2021 • • Panel A meets 5/3 Panel B meets 5/6 • MRR IRB June 2021 Continuing Review have eliminated “staff review” IRs and COPs will eliminate staff reviews the week of May 17 th • REs will continue to have staff reviews for a while Primary and secondary reviewers should address the highlighted items in 314 as part of their summary for IRs

HRP-314 Criteria for Approval Worksheet

HRP-314 and Initial Reviews Determining if IR meets required criteria for approval • Use HRP-314 Section 2 (highlighted parts) when assessing the "111 criteria" during your review (use protocol w/ HRP-314 as a regulatory guide) • WHEN GIVING THE IR SUMMARY: NOT necessary to go through each of these criteria during summary. Sufficient to state the areas that need discussion and can state the other applicable "111 criteria" have been met (use HRP checklists and protocol) • Also refer to the NOTES section of the pre-review checklist (HRP-401) in ARROW for staff to draw your attention to any issues related to these criteria • Use HRP-314 Sections 5 and 7 (highlighted parts) when assessing the regulatory requirements for informed consent during your review (use protocol w/ HRP-314 as a regulatory guide) • WHEN GIVING THE IR SUMMARY: Note any waivers/alterations of consent need to be granted (use HRP checklists and protocol) as well as any other consent issues • Refer to any additional consent waiver/alteration checklists that have been completed in ARROW to determine what waivers of consent are being requested

Website Updates

AND NOW THE REVIEW WALKTHROUGH!

HELP? ? Have you attended/watched all 3 training sessions? • Access them in “Information for IRBMs” on new website • IRB office is tracking who attended trainings/accesses training recordings Broad IEP questions/comments? • Email: IRBDirector@hsirb. wisc. edu Questions on IEP Review process/Toolkit Documents? • Contact ANY ONE of the following people: • IRBM Liaisons: • Jessie Johnson (jessicascott@wisc. edu) • Jackie Lee (Jacqueline. lee@wisc. edu) • Meeting Administrators: • John Cejka (jtcejka@wisc. edu) • Jennifer Fenne (jjfenne@wisc. edu) • Jessie Johnson (jessicascott@wisc. edu) • Anna Martin (awmartin 2@wisc. edu) • Jackie Lee (Jacqueline. lee@wisc. edu)