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.
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:
- A current Human Subjects Research Application* in Word.
If your study is under the One Application Policy, upload your current IRB Stamped Study Application Form.
- 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.
All consent documents individually in Word (i.e., consent, assent, parental permission, data repository consent, etc.)
Recruitment materials in Word
Individual copies of all data collection measures/materials (Word preferred)
- 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.
- Remember to add any missing study team members to the Huron E-Form. Brown's IRB/HRPP is now tracking any study team member who meets the following definition: Identify each additional person involved in the design, conduct, or reporting of the research.
- If a study team member has active CITI training from another institution, make sure to upload this with each study they are associated with.
- If a study team member is responsible for populating the study record or submitting Modifications, then it is recommended that a Study Team Modification be submitted to add this person to the Huron record if they aren't already there. Once added they can be designated as a PI Proxy and then create and submit the population MOD or MOD with changes.
We offer both individual and group sessions for Huron IRB training. These trainings will be conducted by your department's HRPP Contact. Please reach out to [email protected] to request a Huron IRB system training.
Group IRB training sessions for 10 - 30 research faculty and research staff can also be requested!
Sessions will be scheduled starting in mid-May.
Please find the following guidance documents for assistance working within the Huron system.
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].
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.
If I have a shell record in Huron, do I have to populate that record, or can I just create a new study record for my existing protocol?
In order to maintain continuity of your study record (e.g., original approval dates), you should populate the shell record that was migrated from Coeus for your study.
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.