Huron IRB - System FAQs

System Access and Navigation

How do I access the Huron system?

1. Access the Huron IRB system. Use your Ohio State username (last name.#) and password to log in using two-factor authentication (e.g., Duo Security).
2. The Huron system can be accessed using Windows and Macintosh platforms.
3. Please email ORHelpDesk@osu.edu or open a Huron support ticket if you are unable to access the Huron system.

How do I find a submission in the Huron system?

When searching for a study in Huron, select the IRB tab, then click the "Submissions" tab across the top menu bar, then select "All Submissions" in the table below. You can use the Wildcard (%) symbol before typing in the study number, PI name, or study title, if you do not know the exact match for your search. You can change the search type in "Filter by". For example, if you are looking for STUDY20250011 you can type in "%20250011" or "%0011" and it will bring up any study containing those numbers to narrow the search.

How do I navigate back to the main study page from a modification or continuing review submission?

You will find the main study page as a link in the clickable pathway above the title of the modification or continuing review. Click on the study title to navigate to the main study landing page.

New Study Submissions

How do I submit a new initial study in the Huron system?

1. Please refer to the investigator and research staff training on BuckeyeLearn for assistance developing a submission. The module will walk you through the process.
2. The Huron smart form contains help text (viewed by clicking the "?"icon) that will address your questions while completing the application.
3. You will be required to upload a protocol document with your Huron application. Specific protocol templates must be used and can be found embedded within the Huron system library. The 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. 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.
4. Email IRBInfo@osu.edu for assistance or schedule an Office Hours meeting with an ORRP staff member.

How do I obtain the required departmental approval for new initial submissions?

1. All non-exempt initial review applications require departmental approval before they can be submitted. When a new study is ready for departmental review, check the box for "I certify that this submission is ready to be routed for departmental approval" on the submission's Departmental Approval page, click Save or Continue, and then Exit to close the form. The protocol and any other applicable documents will be sent to the PI's departmental endorser via DocuSign. A verification message will then be sent to the PI that identifies their departmental endorser(s). Departmental endorsers may ask the PI and/or research team for more information or request required changes prior to endorsing the study.
2. When ready, the endorser will complete the form via DocuSign which then routes to the PI. The PI must then upload the executed DocuSign form to the submission in the Departmental Approval form section, click Save or Continue, Exit the form, then click Submit.

My submission is stuck in departmental review. Who do I contact to check on this?

Departmental review and sign-off is required before a new non-exempt study can be submitted to the IRB. You can reach out to the departmental endorser identified in the verification message.

My submission was routed to the incorrect departmental endorser. How can this be corrected?

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. The assignment is based on the Principal Investigator’s primary appointment cost center and HR should assign either the Department Leader or Senior Leader role to determine the appropriate endorser. Most departments already have these leadership roles assigned (i.e., department chairs, college deans, and vice presidents) and will not require adjustments. Once a role is assigned in Workday, the departmental endorsement assignments will be activated the next day.

Guidance on security role assignments:

• The Department Leader role is prioritized over Senior Leader.
• Security role assignments made for individual cost centers are prioritized over assignments made at higher levels (i.e., college).
• If your organization has a centralized IRB endorser, assign this person as the Department Leader for each cost center.
• If several individuals are eligible to be an endorser and hold the same priority level (i.e., the security role and organization assignment level combination), those in the Principal Investigator’s supervisory structure will be prioritized for the assignment.
• Workday security may grant additional permissions for an endorser; therefore, choose the most specific role possible.
• Individuals with an eligible security role but having job titles containing the words accounts, accounting, business, budgeting, finance, financial, fiscal, operations, retiree, or revenue will be ignored to reduce incorrect assignments.

System Status and Terminology

Are there differences between terminology used in Buck-IRB compared to Huron?

Yes. The chart below outlines the differences (bolded) and similarities.

How do I check the status of my Huron submission? What do the different statuses mean?

The large orange box in the top left corner of the main study page will tell you the current status of your study. For continuing reviews and modifications, you must be in the specific continuing review or modification submission to check the status.

• Pre-Submission – The submission has NOT been submitted to the IRB. The PI still needs to review the submission and click 'Submit'
• Pre-review – ORRP staff is currently reviewing/screening the submission
• Clarification Requested – ORRP staff have requested clarifications or changes from the PI to make the application complete
• Acknowledged – Reportable New Information (RNI) has been acknowledged
• Active – State for approved submissions reviewed by Ohio State and external IRBs, not human subjects research, lapsed IRB approval, and suspended submissions.
• Approved – The submission has been approved by the IRB
• Closed – The study team closed the study
• Discarded – The study team discarded the submission
• External IRB – This study was approved by an external IRB
• Human Research, Not Engaged – ORRP staff determined that the submission does not engage Ohio State in human subjects research; no further review is needed
• Lapsed – IRB approval has expired
• Modifications Required – The IRB determined that changes are needed for the submission to be approved
• Non-Committee Review – The submission is being reviewed by a Designated Reviewer (IRB member for expedited review, or ORRP staff for exempt applications)
• Committee Review – The submission is being reviewed by the convened IRB
• Not Human Research – The project is considered not human subjects research (NHSR); no further review is needed
• Pending sIRB Review – External study awaiting external IRB approval

Migrated Studies

What do I need to know about my existing study that migrated from Buck-IRB?

1. Active, non-exempt research studies that were initially approved in Buck-IRB are being migrated to Huron. These studies will retain the same protocol number currently assigned in Buck-IRB. Note: existing exempt studies will not migrate to the Huron system.
2. The migrated study's SmartForm fields will be pre-populated with limited information that exists in Buck-IRB (e.g., study title, PI, study personnel, locations of research). IMPORTANT: 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.
3. The Huron system will contain a link back to Buck-IRB for read-only access to the historical information housed in Buck-IRB. Pending amendments and continuing reviews that are not approved before the migration deadline will NOT migrate from Buck-IRB to the Huron system. If this occurs, a new modification or continuing review application will need to be completed in the Huron system.

What do I need to know about my legacy study that did not migrate because it was approved by one of the Ohio State IRBs before Buck-IRB was implemented in 2014?

1. To continue work on the study, you will need to complete one of the required protocol templates and submit it as a new initial application in the Huron system. You must also complete a cover letter (HRP-506, located in the Huron system library) to identify the Buck-IRB study number that the new application will replace.
2. The application will be assigned a new protocol number in the Huron system.
3. If the new application is not approved prior to the expiration date noted in Buck-IRB, the study will expire until the new initial application is approved.

What do I need to know about my legacy study that did not migrate because it was ceded to an external IRB before Buck-IRB was implemented in 2014?

1. To continue work on the study, you will need to complete the External IRB Site Supplement protocol template and submit it as a new request to cede in the Huron system. You must also complete a cover letter (located in the Huron system library) to identify the Buck-IRB study number that the new application will replace.
2. The application will be assigned a new protocol number in the Huron system.
3. You should provide the external IRB with the new Huron system study number to ensure correspondence is appropriately routed.

What do I need to know about my exempt study that did not migrate?

Exempt studies will remain active in Buck-IRB until the study expires (3 years after the initial exempt determination) and will automatically close in Buck-IRB. If revisions are needed to an exempt study that was originally approved in Buck-IRB, a new exempt application must be submitted in the Huron system. All new exempt determinations will be made in Huron.

Continuing Reviews and Modifications

Will minimal risk research that qualifies for expedited review still require an annual status report (ASR) submission after the transition to Huron?

No, minimal risk research currently undergoing administrative review (i.e., ASR) will not require annual submissions in Huron. Instead, the Huron system will issue annual automatic notifications to investigators about the need to submit modifications (previously known as amendments) and Reports of New Information (previously known as event reports). Minimal risk research that currently requires continuing review will still require continuing review in the Huron system.

How do I reply to pre-review comments and requests for revisions?

Once you are ready to submit your response to comments/revisions:

1. Click Edit Study (or Edit Modification/CR) on the left side of the workspace.
2. Use the "Continue" button at the bottom to navigate through the SmartForm or click the name of the page you wish to view on the left sidebar.
3. Use the "Add" button to add a new document to the applicable pages.
4. Use the "Update" button to replace an older version of a document with a revised version. The outdated version will still be accessible in the document history. It does not have to be deleted.
   • Include a tracked changes version for every document you revise other than Microsoft Word documents as the system will automatically generate tracked versions of Word documents.
   • Name documents to clearly show what they are (i.e. protocol, consent form, recruitment flyer). The title you provide is how the documents will be referenced in the IRB approval letter.
5. Click "Save" at the bottom of the screen before you click "Exit."
6. Click "Submit Response" on the left side of the workspace when you have completed the revisions.
   • The "Submit Response" option will only be visible to the PI (or PI Proxy, if one is assigned).
   • In the "Notes" box, type in any responses to comments that aren't reflected in your revised documents. You can also click on the "Add" button to include supporting documentation for your response, such as a response memo if a detailed response is required.
   • Then, click "OK".

How do I submit a continuing review for a ceded/external study?

You do not need to submit continuing review applications for studies reviewed by an external IRB. You also do not need to submit continuing review approval notifications for ceded studies.

Multi-Site Studies and External IRBs

On the Basic Study Information page, it asks me if this study is a multi-site/collaborative study or a single-site study. My study involves other sites, but how do I know which to pick?

1. Multi-Site/Collaborative Study: A study in which two or more institutions coordinate/collaborate on a study, regardless of whether Ohio State will serve as the IRB of record for other institutions.
2. Single-Site Study: A study in which only Ohio State (including Ohio State approved locations) completes all research activities for a specific study.

When should I submit a request to rely on an external IRB?

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.

How do I request to rely on an external IRB?

Complete the New Study SmartForm in the Huron system, indicate that an external IRB will serve as the IRB of record, and attach all requested materials. The PI can submit the smart form by clicking the "Submit" activity. Maintain electronic copies of all information submitted to the external IRB in case revisions are required.

How do I request an Ohio State IRB to serve as the single IRB of record (sIRB) for my collaborative or multi-site research study?

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 initial main application for Ohio State is approved.

Roles and Training Requirements

What are PI proxies and primary contacts?

1. A PI proxy is a study team member designated by the PI to perform tasks on their behalf. Only the PI or PI proxy can officially "submit" applications and responses to the IRB. The Huron system allows for one or more PI proxies to be added to each study. At Ohio State, initial applications, modifications, and continuing reviews must be personally submitted by the PI, which will be confirmed during screening and will be returned to the study team if not submitted by the PI. A PI proxy may submit incomplete responses and responses to IRB modifications. Remember that the PI is ultimately responsible for the ethical conduct of the human subjects study and for compliance with federal regulations, applicable state and local law, and university policies.
2. The primary contact can access the study and will receive study notifications. The primary contact also can create (but not submit) a submission on behalf of the PI. The Huron system allows for only one primary contact to be added to each study.

Will I still need to complete CITI courses to be involved in human subjects research?

Yes, Ohio State requires that all active researchers maintain current CITI training in both Human Subjects Protection (HSP) and Responsible Conduct of Research (RCR). All Ohio State study personnel can log into CITI with their institutional credentials. HSP training is valid for a three-year period and RCR training is valid for a four-year period. After those periods pass, the courses must be repeated.

Generally, it takes up to 24 hours for information to update in the Huron system after training has been completed; however, updates may be delayed in certain rare circumstances. If you do not see updated training information in Huron after 2 business days, please contact ORHelpDesk@osu.edu and provide a copy of the appropriate completion certificate(s). New studies cannot be submitted if either of the required courses are not current for all study team members. If you submit a modification or a continuing review where training is not current, the application will be sent back to you.

Does a lapsed Conflict of Interest (COI) disclosure impact the ability to submit in the Huron system the way it did in Buck-IRB?

Yes, lapsed COI disclosures will impact the PI's ability to submit initial review applications. If you submit a modification or a continuing review in which COIs are not current, the application will be sent back to you via a clarification request.

How do I check CITI training and COI disclosure status for me and my study team?

1. At any time, you may log into the Office of Research Profile at https://orapps.osu.edu/profile/
2. While inside the Huron system, go to the applicable study and click on "Check CITI-COI" at the bottom of the left navigation pane

Can administrative staff be listed as additional contacts as they are in the Buck-IRB system?

No, the Huron system does not have a role designated for additional contacts. The Huron system allows for only one primary contact. If the PI chooses to designate an individual or individuals to submit incomplete responses and responses to IRB modifications on their behalf, they must be listed as either a co-investigator, key personnel, or regulatory staff on the study and the PI would need to designate them as a PI Proxy. All co-investigators, key personnel, regulatory staff, and PI proxies must comply with institutional requirements (i.e., CITI HSP and RCR courses, and a conflict-of-interest disclosure). Please see CITI FAQ for more details.

What options are available for “Role in research” when adding study team members?

The possible roles are “Co-investigator,” “Key Personnel,” and “Regulatory Staff.”

Technical Questions

Can I upload password-protected documents or zip files to the Huron system?

No, please avoid uploading password-protected documents or zip files to the system.

Article ID: 95
Created: February 27, 2025
Last Updated: March 24, 2025

Online URL: https://ohiostateresearch.knowledgebase.co/article/huron-irb-system-faqs-95.html