Huron IRB Submission System

What do I need to know when submitting a new study?

1. The URL to access Huron: https://tamu-irb.huronresearchsuite.com/
2. Visit the Huron Knowledge Center for instructional materials to help you navigate Huron.
   • These materials will walk you through submitting a new study, modification, annual review, personnel change request, not human subject research determination, delayed onset, and reportable new information in Huron. Access the Huron Knowledge Center here.
3. You will be required to submit a study protocol with your Huron application.
   • Moving forward, protocols are required to be uploaded as part of the Huron submission process for review and approval by the IRB. With the introduction of Huron, the submission process will switch from an emphasis on completing a detailed online application to a submitting a brief online application accompanied by a study protocol. Protocol templates are located here.
     • IMPORTANT! Only TAMU protocol templates will be accepted for studies where TAMU serves as the reviewing IRB.
4. You must log into the new Texas A&M SSO CITI URL.
   • IMPORTANT! Complete this step even if your CITI training is up to date. This step is required for your training information to feed into Huron. Your IRB coordinator will no longer be able to manually enter your CITI training information into the system.
   • If you have not yet complete your CITI training, click here for instructions on how to sign up for the required training.
5. Contact your IRB coordinator for assistance.
   • If you are not able to find a solution to your question in the Huron Knowledge Center, contact our IRB staff.
6. As we are all finding our way around a new system, please be aware that there may be some unexpected delays.

What do I need to know about legacy studies that migrated from iRIS to Huron?

1. The IRB will not process any new studies from you until all lapsed studies are brought back to compliance.
   • Click here for instructions on how to find lapsed studies in Huron.
   • If you have a lapsed study, you will need to submit both an annual review and a modification to update the study information and upload all currently approved study materials. Step-by-step instructions for how to complete these requirements may be found here. Please read carefully through these instructional materials to avoid costly errors and unnecessary frustrations. This instructional material will walk you through how to: 1) identify what type of annual review (administrative check-in or continuing review) is required for your study, 2) how to submit a modification in Huron, and 3) how to submit your annual review.
   • IMPORTANT! If your study is lapsed, no study activities may be carried out.
2. If your study is in a lapsed state and it requires a continuing review, you have until January 31, 2024, to get the study back in compliance or it will be administratively closed.
   • You are required to submit a modification to update the study information and upload all currently approved study materials in Huron, at the same time as your continuing review for a legacy study. The Huron IRB system allows you to submit both at the same time. Please click here for step-by-step instructions on how to submit your first submission to a legacy study. This instructional material will walk you through how to: 1) identify if your study requires a continuing review, and 2) how to submit a continuing review and modification in Huron.
3. If your study is in a lapsed state and it requires an administrative check-in, no new submissions will be processed until all lapsed studies are back in compliance.
   • First, you are required to submit a modification to update the study information and upload all currently approved study materials in Huron. Please click here for step-by-step instructions on how to submit your first submission to a legacy study.
   • The study will not be brought back into compliance until the second step is completed by submitting an administrative check-in. Click here for step-by-step instructions on how to submit your administrative check-in through the Reportable New Information (RNI) smart form. The administrative check-in should be submitted immediately after submitting your first modification.
4. If your study is in good standing, you have until your annual review due date to update your application by submitting a modification.
   • If an investigator wishes to continue working on a legacy study that was transferred to the Huron system, a modification will need to be submitted in order to update the study information and upload all currently approved study materials. Please be aware that the only way to add/change information in Huron will be via a modification. You may click here for step-by-step instructions on how to submit your first modification to a hybrid study in Huron. This instructional material will also guide you on how to submit your first annual review for a legacy study.
5. During your first modification to a legacy study, you will need to attach your most recently approved study documents.
   • Study documents were not migrated from iRIS to Huron, and investigators will need to upload their current study documents to Huron during their first modification.

What studies did not transfer from iRIS to Huron?

Exempt determinations, Delayed Onset and Not Human Subjects determinations did not transition to Huron.

• Exempt studies in iRIS will remain active in iRIS until the study reaches the expiration date and will automatically close in iRIS. Only minor modifications to exempt studies in iRIS will be permitted. All other modifications will require you to submit a new study in Huron for a new exempt determination.
  • Moving forward, all new exempt determinations will be made in Huron.
• If you received a Delayed Onset or Not Human Subjects determination in iRIS, you will need to submit a new application in Huron for any follow-ups or upon expiration. For example:
  • If you received a Delayed Onset in iRIS and wish to extend your delayed onset for another year, you will need to submit a new Delayed Onset determination in Huron. Instructions for how to submit a Delayed Onset request in Huron may be found here.
  • If you received a Not Human Subject Research (NHSR) determination in iRIS and need to notify our office of changes to the research activities, you will need to submit a new NHSR determination in Huron. Instructions for how to submit an NHSR in Huron may be found here.