March 21 Huron IRB Migration Update

All Actions Must be Completed in the Huron IRB System

Buck-IRB is now read-only, and all new studies or actions required for studies approved and migrated from Buck-IRB must be completed in the Huron IRB system. Studies approved in Buck-IRB between March 4 – 20 will be available in Huron beginning Monday, March 24. 

Any pending new study, amendment or continuing review submission (e.g., incomplete, modifications required, deferred) in Buck-IRB was not migrated and must be resubmitted in the Huron IRB system. 

Exempt, expired/lapsed and legacy studies (those approved before Buck-IRB) did not migrate. If a legacy study needs to remain open, researchers must create a new application in the Huron IRB system.    

Use Protocol Templates from Huron IRB Only

Before entering a study in Huron, complete the appropriate protocol template from the Huron IRB system, found in the Huron Library [IRB > Library > Templates].  These biomedical and cancer, behavioral and social sciences, exempt and secondary research protocol templates must be used for all investigator-initiated research studies written and designed by an Ohio State investigator.

• HRP-503- Template- Protocol – Biomedical and Cancer Research
• HRP-503a- Template- Protocol – Behavioral and Social Sciences Research
• HRP-503b- Template- Protocol – Secondary Research
• HRP-503c- Template- Protocol – Exempt Research

For multi-site research studies not written or designed by an Ohio State investigator (i.e., provided by an external site or sponsor), the Ohio State or External Site supplemental protocol templates must be completed and uploaded with the external protocol. 

• HRP-504- Template- Protocol – External IRB Site Supplement
• HRP-505- Template- Protocol – Ohio State IRB Site Supplement

Personnel Change Modifications

 Adding/removing Ohio State researchers to/from a study is a simple and speedy process in the Huron IRB system.  Attempting to add external collaborators during this process will delay the modification review and will engage the ORRP reliance team. For time-sensitive internal study team additions, please ensure that the member(s) are Ohio State personnel before submitting the personnel change modification.

Departmental Endorsers 

If the departmental endorsement DocuSign envelope is sent to the wrong person, the envelope can be reassigned to the correct person by logging into docusign.com and using the reassignment feature. This action will allow the immediate envelope to be signed by the correct endorser without additional delays. Instructions for reassignment are available on the DocuSign support pages.

To avoid the assignment of incorrect departmental endorsements for future submissions, the unit’s HR personnel must assign the correct security roles in Workday to the appropriate departmental endorser. Learn more in the Huron IRB FAQs. 

Multi-site or collaborative research 

New requirements for external studies (i.e., Ohio State studies that cede review to an external IRB):

• The Huron IRB system requires all external IRB site approval and closure notifications to be recorded in the system. Please email the approval and closure notices to irbagreements@osu.edu, and ORRP will administratively open/close them in the Huron system. (Note: ORRP currently receives site approval and closure notifications from WCG IRB and site closure notifications from NCI CIRB, so these notices do not need to be forwarded to irbagreements@osu.edu).
• All changes to Ohio State’s required consent and HIPAA research authorization boilerplate language must be reviewed by ORRP staff through a modification submission in the Huron IRB system. Study teams will receive a modification approval letter that will need to be provided to the external IRB. (Note: This also applies to all WCG and Advarra requests)

Changes to multi-site studies when Ohio State is the reviewing IRB:

• Before a participating site (pSite) can be added to a study in Huron, the parent study must be designated as multi-site or collaborative research during the study’s initial review or during a modification review. A pSite may then be added through a submission that is linked to the parent study.
• External site personnel (who rely on Ohio State as the IRB of record) no longer need to be listed in the Huron IRB system. Relying sites are responsible for ensuring that their study personnel are locally approved and have completed local training and conflict of interest reporting requirements.

Get Help Navigating Huron

Researchers needing help navigating the new Huron IRB system can attend upcoming office hours to ask questions and learn more about the system. These virtual sessions will focus on the differences between the Buck-IRB and Huron IRB systems, including where to find and how to use needed submission materials. For those needing IRB regulatory guidance, separate office hours are available through the Research Commons.