Buck-IRB to Huron IRB Transition Guide

• Take Training: Complete PI and Study Staff module in BuckeyeLearn - great way to become familiar before logging in
• Login: Ohio State username (last name.#) + password + Duo Security
• Find Resources: Go to IRB > Library for templates and guides
  • Investigator Manual (General tab) - comprehensive IRB process overview at Ohio State
  • Standard Operating Procedures - replace Ohio State's HRRP policies
  • Protocol templates, checklists, and worksheets
• Use Help Text: Click "?" icons in SmartForms for guidance while completing applications
• Remember: All new submissions must include both SmartForm AND appropriate protocol template

• Check Buck-IRB: Log into Buck-IRB to see which studies have "Migrated to Huron" status (these are now read-only in Buck-IRB)
• Access in Huron: Log into Huron IRB system using Ohio State username (last name.#) + password + Duo Security and find. your studies - IRB > Submissions > All Submissions dropdown
• Same Protocol Numbers: Studies keep their original Buck-IRB numbers
• Only Migrated Studies Visible: You'll only see studies that transferred from Buck-IRB

• Get Template: Download from IRB > Library > Templates
• Complete Protocol: Fill out template before entering Huron
• Submit Both: SmartForm + Protocol template required

• Study already in Huron? → Submit modification through Huron
• Study still in Buck-IRB? → Must transition to Huron templates by March 2026
• Not sure? → Check Buck-IRB for "Migrated to Huron" status

• Ohio State Personnel: Use personnel change modification
• External Collaborators: Will delay modification review and engage ORRP reliance team
• Time-Sensitive Additions: Ensure members are Ohio State personnel before submitting
• Requirements: All co-investigators, key personnel, and PI proxies need CITI HSP/RCR training + conflict disclosure
• Available Roles: Primary Contact (1 person), PI Proxies (multiple allowed)

• Wrong Endorser: Log into docusign.com and use reassignment feature immediately
• Future Prevention: Have HR assign correct security roles in Workday
• No Delays: Reassignment allows immediate signing by correct endorser

Ohio State as Participating Site (External IRB Review):

1. Wait: Submit after the external IRB has approved the study
2. SmartForm: Complete indicating external IRB as IRB of record
3. Documentation: Maintain electronic copies of all submitted materials

New Requirements for External Studies:

• Site Notifications: Email ALL approval and closure notices to irbagreements@osu.edu - ORRP will administratively open/close them in Huron
• Consent Changes: ALL changes to Ohio State's required consent and HIPAA boilerplate language must be reviewed by ORRP through modification submission in Huron
• Approval Letter: Study teams receive modification approval letter to provide to external IRB
• WCG/Advarra: These requirements also apply to all WCG and Advarra requests

Exception: ORRP already receives notifications from WCG IRB and NCI CIRB - don't forward these

Ohio State as Lead IRB (Single IRB of Record):

1. Initial Setup: Mark as multi-site study on SmartForm
2. Lead Role: Select "Yes" to acting as single IRB of record
3. Sequence: Get main application approved first
4. Add Sites: Use "Add Participating Site" activity for each site
5. Site Approval: Participating sites cannot reach final approval until main application is approved

Important Changes for Ohio State as Reviewing IRB:

• Designation Required: Parent study MUST be designated as "multi-site" or "collaborative research" during initial review OR modification review before adding participating sites
• Linked Submissions: Participating sites added through submissions linked to parent study
• External Personnel: No longer need to be listed in Huron system - relying sites handle local approvals, training, and conflict reporting

• Submitting SmartForm without protocol template
• Using old Buck-IRB templates
• Not completing training before starting
• Downloading/storing library documents (they update automatically)

• Adding external collaborators during personnel changes (causes delays)
• Having wrong departmental endorser in system
• Forgetting CITI HSP/RCR training for team members

• Not designating as multi-site during initial review
• Adding participating sites before parent study approval
• Forgetting to email site notifications to irbagreements@osu.edu