Division of Research
Submit Your Human Subjects Research Study
About the Huron System
Huron can be accessed using Windows and Macintosh, with Mozilla Firefox and Google Chrome browsers. It cannot be accessed with Microsoft Internet Explorer or Microsoft Edge.
Log In or Request Huron Access
Log in to Huron using your Brown credentials and two-factor authentication. For Huron access or support, submit a request through Research Administration Information Systems (RAIS).
Study Workflow in Huron
There are five main stages of workflow when you submit a study protocol for IRB review in Huron — Pre-Submission, Pre-Review, IRB Review, Post Review and Review Complete — with additional steps in between as needed for clarifications and modifications.
Pre-Submission is a staging area for your study submission, where you can prepare information and gather necessary forms and documentation. At this stage, the study has not been submitted for HRPP/IRB review. To move the study to HRPP/IRB review, the PI or PI Proxy must select Submit under the Next Steps on the left-hand menu.
Once submitted, the study moves to the Pre-Review stage and is in the queue for HRPP/IRB pre-review. Once the study is actively under pre-review, you can see the name of the staff member assigned to your submission as the IRB coordinator, under Study Title at the top of the page.
If moved to the Clarification Requested stage, the IRB Coordinator or Designated Reviewer has opened the submission to the study team for response and edits. Review Clarifications Requested in the History tab and Submit once revisions have been made. Once Submit has been selected, the study will move back to HRPP/IRB for review.
When moved to the IRB Review stage in the system, the study has completed the Pre-Review stage and is ready for IRB Review by a Designated Reviewer or the convened IRB. You may see the same or new IRB Coordinator named for your submission at this stage. More detailed information on the date of the meeting will be available in the History tab.
A study is moved to Post Review once it has completed the IRB Review stage and received a determination either from the Designated Reviewer or convened IRB. The HRPP will generate and send a memo to the PI and study team (if applicable) with the review determination within 1-5 business days, depending on the type of review conducted.
If a study is moved to the Modifications Required stage, the convened IRB is requesting modifications in order to secure final approval.
When moved to Review Complete, the study has been reviewed and the PI has responded to any modifications from the convened IRB, if requested. The study status is now available in the top left corner in the orange box. The HRPP will generate and send a memo to the PI and study team (if applicable) with the review determination within one to five business days, depending on the type of review conducted.
How to Manage Submissions in Huron
The HRPP team provides guidance documents to assist investigators in managing human subjects research study submissions in the Huron system.
- Creating a New Study Submission [Google Doc]
- Creating a Modification [Google Doc]
- Creating a Modification to Populate the Study Record [Google Doc]
- How to Add a PI Proxy [Google Doc]
- How to Add Funding [Google Doc]
- How to Respond to a Clarification Request [Google Doc]
- Study Team Members Page and Modification [Google Doc]
- Submitting a Continuing Review [Google Doc]
- Submitting Reportable New Information [Google Doc]
- Submitting a Study Closure Request [Google Doc]
- PI Guidance : How to Submit for a 118 Determination [Google Doc]
Collaborative Research Guidance
- Creating a Multi-Site Study to Rely on an External Site [Google Doc]
- Adding a Relying Site to Approved Studies [Google Doc]
- Nonreliance Collaborative Research [Google Doc]
- Adding a Community Collaborator to Approved Studies [Google Doc]
- Updating Information for Studies under External IRB Review [Google Doc]
- Populating the Record for Studies under External IRB Review [Google Doc]
Tips for Submitting Your Study
Use Updated Forms
Forms are periodically updated to meet any changes in federal regulations and Brown policy. Submissions using forms that are more than 30 calendar days out of date will not be accepted. Visit the HRPP/IRB Forms and Templates page for the most current materials.
HRPP/IRB Submission Forms and Templates
Follow the Single-Submission Policy
For an accurate sequential review of your study submissions, the HRPP team will only accept one submission per study at a time. For example, if you have a continuing review under review, you may not submit a modification for the same study until the first submission (i.e., your continuing review) is approved.
Reportable New Information (RNI) submissions are the only exception to this policy. RNI may be submitted at any time.
Consider How Reviews are Prioritized
The HRPP cannot guarantee that all requests for priority review will be granted; however, the team strives to accommodate requests whenever possible and reasonable. HRPP staff and the IRB prioritize protocol reviews as follows:
- Continuing reviews based on expiration date
- Protocols requiring review by the convened IRB
- Protocols with pending funding
Please use the Add Comment function in the Huron system to upload documentation from the funding sponsor stating the requested IRB approval date.
- Protocols with a time-sensitive start date
Please use the Add Comment function in the Huron system to include an explanation of the time constraint and the requested IRB approval date.
Expect a Holistic Review
The HRPP team and IRB conduct a holistic review of your active study with each submission as part of normal review procedures to ensure it remains in compliance with current federal regulations, Brown policies and IRB position statements. For example, if modifying compensation on a flyer, HRPP will review the entire flyer to confirm that it meets Brown's current recruitment policy.
30-Day Response Deadline
During each stage of a submission’s review cycle (i.e. Pre-Review, IRB Review, and Post Review), PIs have 30 calendar days from the first clarification request to respond to feedback and complete that stage of review. The 30-Day Response Deadline resets with each new stage. Submissions may be discarded after 30 calendar days due to a lack of response by the PI.
Planning an Undergraduate Research Study?
If the study is an undergraduate project and the student’s intent is to work with human subjects it may require HRPP review, as long as it meets certain conditions. You must submit an Undergraduate Project Application for HRPP’s review at irb@brown.edu.
Next Steps for Approved Studies
Once a study receives HRPP/IRB approval, the investigator may begin any research activities that are not being held up by ancillary reviews by other boards or offices. The HRPP team provides the following guidance to help ensure your study maintains compliance.
If you need to make changes to the approved study you should submit a modification in the Huron system prior to implementing any changes, and the review cycle will start again.
Register Your Clinical Trial
If your study meets the federal definition of a clinical trial, make sure you understand the registration and reporting requirements.
Reportable Events
Refer to IRB policy if your study has a reportable event. All reportable events are submitted in Huron as Reportable New Information (RNI).
- IRB Policy on Reportable Events and Noncompliance
- Mandatory Reporting
- Submitting Complaints and Concerns to the HRPP
Submit Continuing Reviews
Submit regular progress reports as required if your study falls under the category for Continuing Reviews by the HRPP/IRB.
Follow Best Practices
Consider signing up for the Quality Assurance / Quality Improvement Program’s Best Practice Reviews for individualized support and guidance to assist with protocol maintenance and ensure compliance. If you prefer self-guided post-approval monitoring, use the Best Practice Checklist as an independent guide to confirm compliance.
Complete Requirements for Study Closure or PI Transition
When your study is complete and you are ready to close it, or if you are an investigator leaving Brown but the study is ongoing, make sure to follow all applicable University policies regarding data management and transferring subawards, equipment, data, materials, research, licenses and more.
- Submitting a Study Closure Request [PDF]
- Research Data Management
- Research Data Management Offboarding Checklists [PDF]
- Transition Guidance for Outgoing Faculty
Modifications to Exempt Research
Minor modifications do not require review and approval if the research remains within the exemption category(ies) determined to be applicable to the research.
Examples
- Changes to eligibility criteria that fall within the scope of the approved research and do not increase risk
- Adding non-sensitive questions to a survey or interview or revising current measures within the scope of the approved aims
- Adding recruitment material that follows IRB guidelines
- Increasing or decreasing the approved enrollment number
- Administrative revisions to study documents (i.e. clarity, grammatical corrections) that do not alter the approved purpose of the material
- Revisions to study timelines
- Change of study team members
Certain specific or significant changes that impact the review category or increase the risk profile must be submitted to the HRPP/IRB for review and approval.
Specific Examples
- Studies that received a Limited IRB Review
- Change of Principal Investigator
- Adding a new funding source
Significant Examples
- Changing the study purpose or aims
- Addition of a vulnerable population
- Addition or change to physiological data collection outside of the current review category
- Adding sensitive questions about participants’ health or behavior (i.e. diagnosis for illness or disease, illegal conduct or traumatic events)
- Changes to sources or identifiability of data outside of the current review category
- Adding external collaborators or sites (each site must obtain their own Exempt Determination from their home institution)
For further assistance, use the self-assessment tool to evaluate if the modification requires a submission for review and approval.