Live May 2023 - Huron IRB Electronic Submission System

 

                                                                                                                                                                                                                                                                        Huron Knowledge Center 

Implementation	Data Prep	Migration	Training
System Guidance	Contact	FAQs

Last Update: May 16, 2023

Key Dates   April  21 - May 12 Submission black out - no new submissions accepted May 15 Huron IRB system live

Brown has chosen the Huron IRB electronic submission system as the University’s new research administration system. Huron was chosen after more than two years of comparative system testing by multiple stakeholder groups, including HRPP and ORI staff, BhRAG members, IRB members, and other key members of the research community.

The new system, Huron, will migrate selected data elements from the current research software, Coeus, to create a single portal for principal investigators and study team members, improving routing and business processes that will make review of submissions more efficient. The new electronic system will enable faculty and staff to manage study submissions in one integrated dashboard. We will use Huron for all human subjects business processes - from submission, review, and approval to post-approval monitoring - as well as to facilitate University required ancillary reviews (e.g., biosafety, radiation safety, OIT review).

Submission Blackout

The Brown HRPP/IRB will have a submission blackout April 21st through May 12th. Researchers should plan accordingly as the submission blackout includes time sensitive full board submissions. The Brown HRPP will not accept any submissions during this time including new studies, modifications or progress reports. 

Convened IRB submissions (studies that are greater than minimal risk requiring review at the May IRB meeting) will be reviewed on a case by case basis if accepted by the May meeting deadline and the submission is in a reviewable state. Full Board submissions not in a reviewable state by the May meeting deadline will be withdrawn from review and investigators will be required to be resubmit in Huron for the June meeting. 

At the conclusion of the submission blackout on May 12th, all submissions will be required to be submitted in the Huron e-submission system (new studies, amendments, progress reports and reportable events).

When will it be implemented?

The IRB module is expected to be operational Monday, May 15, 2023. 

Data Preparation

The Office of Research Integrity’s QA/QI Administrator and HRPP staff are conducting multiple data integrity initiatives to prepare for the migration of active research studies to Huron. These data integrity initiatives involve an extensive review, cleaning and updating of all active human subjects protocols tracked in the current Coeus system. The data cleaning efforts are being implemented to ensure that only currently active studies are migrated to Huron and also to avoid the burden of unnecessary migrating non-active studies. The IRB and HRPP staff request study teams are responsive to any requests for additional information related to active protocols.

Protocol Migration

The following documents must be uploaded into the system at the time of the first modification in the Huron IRB system. If the study does not have a modification or progress report submitted over the course of the year, a modification must be submitted by May 1st, 2024 to complete the record population or the record will be administratively closed by the HRPP/IRB. 

Study staff will be responsible for creating and submitting a new modification with all of the below materials to populate each study’s record. A modification to complete the population of the study record can be created at any time before May 1, 2024, but we strongly recommend starting  this process early. The IRB cannot approve any new changes to the study without investigators completing this first modification. This means if an investigator would like to add new measures to their study, a modification must be created to (1) upload all study documents to the study’s record and (2) upload the new measures to the study’s record. 

If there are no changes to the study and the modification is submitted for the sole purpose of uploading the study documents, study teams can create a modification and use “Upload of approved study materials” as the modification description. 

When the system is live on May 15th, all active studies will have a “shell” record migrated into Huron IRB system. The “shell” record will contain the following: the protocol number, the study title, the PI name, funding, research locations (e.g. reliance agreements), any drugs or devices, and review type/determinations. The following materials will need to be uploaded by the study team:

1. A current Human Subjects Research Application* in Word. 

   1. If your study is under the One Application Policy, upload your current IRB Stamped Study Application Form.

   2. If your study does not fall under the One Application Policy (i.e. you do not have an IRB Stamped Study Submission), complete and upload the Human Subjects Research Application in Word.

2. All consent documents individually in Word (i.e., consent, assent, parental permission,   data repository consent, etc.)

3. Recruitment materials in Word

4. Individual copies of all data collection measures/materials (Word preferred)

5. Any additional materials, including but not limited to, letters of support, applicable Appendices, data use agreements, reliance agreements, drug brochures, etc. 

*Applications that are under the One Application Policy are in compliance with current Brown policies and federal regulations, and do not require a new Human Subjects Research Application.

Any study team with a modification request planned for the summer of 2023 that would like assistance populating the study record to ensure timely review, please reach out to your department’s HRPP Contact to schedule a meeting or sign up for a training session. 

Huron IRB Training

We offer both individual and group sessions for Huron IRB training. Please choose the type of training that best suits your training needs by clicking the applicable RSVP box below.                                                                                                                                                                                                                                                               

Training sessions on how to navigate the Huron IRB system will be held by the Research Administration Information Systems (RAIS) team and the HRPP staff. Training session dates will be listed below once scheduled and available for registration.
 

• May 11, 11 am - 12 pm: Huron navigation & initial submissions

• May 17, 12 pm - 1 pm: Huron navigation & initial submissions 

• May 25, 2 pm - 3 pm: Huron navigation & initial submissions      

• June 1, 12 pm - 1 pm: Huron navigation & initial submissions

• June 16, 11 am - 12 pm: Huron navigation & initial submissions 

• June 28, 11 am - 12 pm: Huron nagivation & initial submissions 

• July 13, 11 am - 12 pm: Huron navigation & initial submissions 

• August 15, 9 am - 10 am: Huron navigation & initial submissions 

• August 31, 3 pm - 4 pm: Huron navigation & initial submissions 

• September 12, 10am - 11 am: Huron navigation & initial submissions 

__________________________________________________________________________________

​Group IRB training sessions for 10 - 30 research faculty and research staff can also be requested! 
Sessions will be scheduled starting in mid-May.                                                                                                                        

    

System Guidance     

Please find the following guidance documents for assistance working within the Huron system. 

• New Submission
• Modification
• Continuing Reviews and Closures
• Funding Modification
• Study Team Member Modification
• Lifecycle of a Submission
• How to add a PI Proxy       

Collaborative Research

• Creating a Multi-Site Study to Rely on an External Site
• Adding a Relying Site to Approved Studies
• Adding a Community Collaborator to Approved Studies

Contact

This website will serve as a centralized resource to obtain project updates and view information related to the implementation and training of the Huron IRB submission system. For more information, please contact [email protected].

FAQs 

Data Migration Questions:

What is the deadline for uploading study materials to the study record?

A modification to complete the population of the study record must be submitted before May 1, 2024. The IRB cannot approve any new changes to the study without investigators completing this first record population modification. Record population must be submitted before any new changes or a progress report can be approved. 

The Data Migration Plan mentions, “if your study does not fall under the One Application Policy (i.e. you do not have an IRB Stamped Study Submission), complete and upload the Human Subjects Research Application in Word." Does this mean that any protocol approved prior to May 2022 needs a new Application?

Only submissions that are not stamped with the Brown University IRB Approval DATE in the footer will require a new Human Subjects Research Application. This would apply primarily to any submission approved before May 1 2022. Contact HRPP by email with the protocol number if you would like confirmation of the need for a new Application. If the study was not under the One Application Policy and you have been submitting Revision Request Forms without updating the Application, you will need a current Human Subjects Research Application in Huron. 

What do we do with studies that have had amendments? Should we also be uploading all associated amendment request forms?

No, you will not upload amendment request forms to Huron. 

Huron System Questions:

How can I find out where my protocol is in the submission process?

All study records have a study timeline on the study workspace. When you select a study record, see the yellow oval for your study’s current status.

If the Pre-Submission bubble is yellow, please be sure to select “Submit” in the left hand menu to send it to the IRB for review. If the Pre-Review bubble is yellow, the study is with the HRPP/IRB for review. If the Clarification Requested bubble is yellow, this means the HRPP/IRB is waiting on the study team’s response. If the Review Complete bubble is yellow, this means the study has been approved and received its review determination. 

When do I need to submit my study in Huron to ensure it gets assigned for review at an IRB meeting?

See current meeting dates on the Full Board Meeting and Deadline Dates page.

How do I inform the IRB about my JIT deadline or other time sensitive deadlines?

After you submit the record in Huron, select Add Comment in the left hand menu under Next Steps. You can also email the IRB inbox ([email protected]) with the protocol number and title along with documentation of the JIT or other deadline. 

 

Do I need to submit a continuing review in Huron?

Huron will send Principal Investigators, Primary contacts and PI Proxies multiple email notifications to inform you of an expiring study that includes the expiration date. You can also see the study’s expiration date in the top left hand corner of each study record. Note, not all studies will have an expiration date and require a continuing review submission.

Are modifications for adding funding and study team members handled differently than substantive modifications?

All modifications are submitted the same way. Funding and study team member changes are typically considered minimal changes and will be reviewed following the review times available on our page. 

Will suggestions for filling out the “Basic Study Information” and other pages be available?

Yes, HRPP has Investigator Guidance documents that are available including a New Submission Guidance document that will walk through each of the SmartForm questions and the pages in the study record.

Is there help text within the system?

Yes! If you click on the blue question mark next to the question, there will be Help Text provided there.

 

There is help text available in the top right corner of each Smart Form page.

Additional help text covering topics such as how to Navigate the Study Workspace and Respond to a Clarification Request can found in the top right corner of study workspace.

 

 

Is each document added separately or do we have to create one large Word document file? 

Each document is uploaded as an individual Word document to its corresponding space within the Smart Form. 

Does the Study Team Members page include Research Assistants at other sites in a multi-site study?

Yes, you should include research assistants for a multi-site study within the Local Study Team Members tab. Study teams should identify each non-Brown affiliated person involved in the design, conduct, or reporting of the research. These would be individuals who are not covered by another institution’s IRB review and may require an Individual Investigator Authorization. Individual investigators are 1) not affiliated with Brown University or 2) acting as an employee or agent of an institution that is not engaged in the research. Contact the HRPP by email or leave a comment in the main study workspace if there are questions about who to include. 

Should Good Clinical Practice training certificates be uploaded if they are not through CITI?

Yes, upload any training certificates to Question 3 Study Team Member Information on the Study Team Members page.