Huron IRB Go-Live Information

Watching the PI and Study Staff training module in BuckeyeLearn is a great way to become familiar with the system before logging in.  

Researchers can log into the Huron IRB system by using their Ohio State username (last name.#) and password, and two-factor authentication (e.g., Duo Security).  

• The Investigator Manual, found in the Huron IRB system Library, under the General tab, provides a comprehensive overview of the IRB process at Ohio State. Also in the library, researchers can find Standard Operating Procedures (that replace Ohio State's HRRP policies), protocol templates, checklists and worksheets.
• The Huron SmartForm also contains help text (viewed by clicking the "?" icon) that will address questions while completing the application.
• All new submissions must include both the SmartForm and the appropriate protocol template found in the Huron IRB system.

Step 1: Log into Buck-IRB to see which studies have a status of “Migrated to Huron.”  These studies have moved to the Huron IRB system and are now read-only in Buck-IRB.   

Step 2: Log into the Huron IRB system by using your Ohio State username (last name.#) and password, and two-factor authentication (e.g., Duo Security) to see the migrated active studies. These studies will retain the same protocol number assigned in Buck-IRB. Only studies migrated from Buck-IRB will be visible in the Huron IRB system. When searching for a study in the Huron IRB system, select the IRB tab, then click the Submissions tab across the top menu bar, then select All Submissions in the dropdown menu. 

As a reminder, the following will not migrate to Huron:   

• Exempt Studies 
• Legacy Studies (studies approved prior to the implementation of Buck-IRB)
  • Note: if you would like to keep a legacy study open, you will need to create a new application in the Huron IRB system (see Submitting New Studies). 
• Expired/Lapsed Studies  

The Huron IRB system submission process is similar to that in Buck-IRB, with both utilizing a SmartForm and protocol templates. All new submissions must include both the SmartForm and the appropriate protocol template found in the Huron IRB system. 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

Once in the system, researchers will find resources needed to navigate the IRB process under the library tab. This collection of resources was developed by Huron policy experts and refined to meet Ohio State standards. One of the benefits of the Huron IRB system is that the resources are updated as rules, regulations and procedures change. It is recommended to access the resources through the Huron library instead of downloading and storing them.

Additional resources include Huron User Guides located in the Huron IRB system library.

• New External IRB Studies: For studies where Ohio State is a participating site (pSite), requests to rely on an external IRB should be submitted after the reviewing IRB (sIRB) has approved the study. Complete the New Study SmartForm in the Huron IRB system, indicate that an external IRB will serve as the IRB of record, and attach all requested materials. The PI can submit by clicking the “Submit” activity. Maintain electronic copies of the information submitted to the external IRB in case revisions are required.
• New Ohio State as Single IRB of Record (sIRB) for Multi-site Studies: On the New Study SmartForm, indicate if the study is a multi-site or collaborative research study, then select "Yes" to the question "Will your IRB act as the single IRB of record for other participating sites?" Complete the rest of the SmartForm and attach all required materials. Participating sites are added separately by executing the "Add Participating Site" activity. The PI can submit the SmartForm by clicking the "Submit" activity. The participating sites will not be able to reach final approval (i.e., be declared active) until the Ohio State initial main application is approved. 

See also Multi-site or Collaborative Research.

At Ohio State, initial applications, modifications and continuing reviews must be personally submitted by the PI. The Huron IRB system does not have a role designated for additional contacts like in Buck-IRB, however, PIs can designate:  

• One primary contact, who can access the study and who will receive notifications for each study. The primary contact also can create (but not submit) a submission on behalf of the PI.
• One or more PI proxies, who can perform tasks on their behalf. A PI proxy may submit incomplete responses and responses to IRB modifications.

Note: All co-investigators, key personnel, and PI proxies must comply with institutional requirements (i.e., CITI HSP and RCR courses, and a conflict-of-interest disclosure).  

Studies migrated to the Huron IRB system from Buck-IRB that require modifications to the study or information that currently exists in the Buck-IRB application must transition to the new Huron protocol template starting in March 2026. Studies that do not require modifications to the protocol or Buck-IRB information may continue to operate under the existing protocol indefinitely.

To minimize disruptions, study teams can submit multiple modifications to the study, which would gradually transition the Buck-IRB application information and current protocol to the Huron protocol template.

When submitting modifications, complete the Huron IRB system SmartForm and describe the proposed changes. If the modifications:

1. only affect information in the Buck-IRB application, complete the relevant sections of the Huron protocol template and/or appendices.
2. only affect the currently approved protocol, provide a revised protocol with the proposed changes incorporated.
3. affect the same information in both Buck-IRB and the currently approved protocol, revise only the currently approved protocol.
4. affect different information in Buck-IRB and the currently approved protocol, follow the guidance for both scenarios 1 and 2 above.

Note: this guidance does not apply to all modifications (e.g., changes to study team members or documents).

It is possible that studies may operate under two protocols: the existing protocol document and the Huron protocol template. Once the Huron protocol sections and appendices have been revised and approved, the corresponding sections of the Buck-IRB application are no longer valid.

All resources needed to navigate the IRB process can be found in the Huron IRB system library, including a Human Research Protection Program (HRRP) toolkit. This toolkit is a collection of resources developed by Huron policy experts and refined to meet Ohio State standards. One of the benefits of the toolkit is that it is updated as rules, regulations and procedures change. It is best to access the resources through the Huron library instead of downloading and storing them.

The resources can be located in the library tab, and contain the following document types:  

• Standard Operating Procedures that replaced the Ohio State HRRP policies. These can be used as a reference for study teams, researchers and reviewers, and can be located by title in the library.  
• Protocol Templates (including those for biomedical/cancer, social and behavioral sciences, exempt research and secondary research) are to be used by the researcher as a starting point for drafting new protocols. A protocol must accompany the SmartForm when submitting a study.
• The Investigator Manual (under the General tab) contains Ohio State-specific information.  
• Checklists are used by IRB reviewers to document regulatory decisions.  
• Worksheets are tools for the IRB reviewer, ORRP staff and researchers, and provide guidance for research-related procedures.  

A Toolkit Document Crosswalk has been created to help researchers navigate the change from Buck-IRB to the Huron IRB system.

• Principal investigators (PI) and study staff: A brief training is available in BuckeyeLearn that provides an overview of the Huron IRB System. The training is indexed to allow navigation directly to any topic of interest. This training will be updated throughout the transition period with new content added as appropriate.  
• IRB Committee members: A brief training is now available for IRB members in BuckeyeLearn. The module provides an overview of the Huron IRB system and a tour of the review process.  

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.

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. 

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.

• Technical issues: If you are unable to access the Huron IRB system or information in the Huron IRB system is incorrect or missing, please submit a ticket to the ORIS Help Desk Support.  
• Huron Help Center: In addition to the toolkit documents, the Huron IRB system Help Center contains additional materials to help researchers navigate the system.
• Frequently Asked Questions: FAQs have been established and will be updated as necessary to help answer common questions.  
• ERIK Knowledgebase: Find step-by-step guides to assist with technical questions.
• Crosswalk: The previous Ohio State Human Research Protection Program (HRPP) policies have been retired and replaced with Huron toolkit documents. A Toolkit Document Crosswalk has been created to help researchers navigate the change from Buck-IRB to the Huron IRB system.
• Tip Sheets: Tip sheets have been created to help researchers navigate the Huron IRB system, including: Create a New Study; Reportable New Information (formerly Event Reporting); and Respond to a Clarification Request.
• Contact ORRP Staff:  Researchers needing help navigating the new Huron IRB system can attend upcoming virtual office hours scheduled through April 18. These 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. Questions can also be directed to IRBInfo@osu.edu.