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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.

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]

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 Submissions using forms that are more than 30 calendar days out of date will not be accepted.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.

HRPP/IRB Review Process

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?

Review HRPP's information regarding undergraduate work involving human subjects. Questions can be directed to irb@brown.edu.

Undergraduate Work Involving Human Subjects

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.