Huron IRB Electronic Submission System | Research at Brown

Protocol Migration Information and Steps

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, but we strongly recommend submitting the Modification as soon as possible. The IRB cannot approve any new changes to the study or submit Reportable New Information (RNI) without completing this first modification to populate the study record. This means if an investigator would like to add new measures to their study or submit RNI, a modification to upload all study documents to the study’s record must be submitted and approved prior to requesting new changes to the study or submitting RNI.

All active studies have a “shell” record migrated into Huron IRB system. The “shell” record contains 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 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.

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Step 1: Pay special attention when selecting the Modification Scope in the e-form. If you are uploading study documents to populate your record AND adding study team members you will need to select both ‘Study team member information’ and ‘Other parts of the study’ for your Modification scope.

Step 2: Upload current approved study documents into the record in Huron by using the PI Guidance: Populate the Study Record Huron guidance document or using the PI Guidance: Populating the Record for Externally Reviewed Studies for studies in which Brown has ceded review to another IRB.

Tips for Step 2: Be sure to check your original approved application is under the One Application Policy (an IRB stamped study submission). If you don’t, you will need to complete and upload the Human Subjects Research Application in Word.

Step 3: If applicable: Add study team members to the Huron record by following the steps in the PI Guidance: Study Team Members Page & Study Team Member Modifications guidance document. This is the only other change allowed when populating the study record. Study team members can begin study activities as soon as possible as long as they have required CITI training (initial education requirements and/or additional initial education requirements) for conducting human subjects research. If any study team member, including the PI, has CITI training from an outside institution, the CITI certificate(s) will need to be manually uploaded into the record (see here for more information). This means that the study team members who are up to date on CITI do not have to wait until the Modification is approved to begin study activities.

Step 4: Make sure all study documents are in Word format.

Step 5: Click ‘Finish’ (clicking ‘Finish’ does not mean the submission is in our queue for review, it just means you have finished all required steps for creating a submission).

Step 6: Click ‘Submit’ under ‘Next Steps’ within the study record workspace (clicking ‘Submit’ will bring the submission to Pre-Review which means it is now in our queue for review). See here for Lifecycle of a Submission in Huron.

Tips for Steps 5 & 6: When viewing the study workflow, Pre-Submission indicates the submission is not yet submitted for HRPP/IRB review (this means you can still edit and make changes if needed). Pre-Review indicates the submission is now with the HRPP/IRB office for review (this means that the submission is closed for editing unless it is ‘Withdrawn’ or ‘Clarification Requested’ by the IRB Coordinator assigned to review the submission. See here for Lifecycle of a Submission in Huron.

Protocol Migration Tips

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. As a reminder, as long as study team members have the required CITI training, they can begin study activities and do not have to wait until the Modification to add them to the record is approved.
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.

Huron IRB Training

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.

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

Huron System Guidance

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

Collaborative Research

Huron Glossary

Discard: Choosing this option will delete the submission and remove it from the review queue. New studies that are discarded can be copied (using the "Copy Submission" button) to create a new study record with all documents from the previously-discarded study available for revision. Modifications that are discarded cannot be copied, so a new modification request will have to be created by the study team.

IRB Coordinator: HRPP staff member who is assigned to pre-review your submission. An IRB Coordinator won’t be assigned until the intake review process is complete and your submission has been entered into the review queue.

PI Proxy: A PI proxy is a study team member who is granted the authority to submit on PI’s behalf. A modification request is not required to designate a PI proxy, but only individuals who are already approved as study team members can be designated as a PI Proxy.

Primary Contact: The primary contact will receive all email notifications related to the submission and be able to create new Modifications, Continuing Reviews and Reportable New Information, but does not have the ability to create or submit on behalf of the PI.

Study Team Member: Brown-affiliated persons involved in human subjects research activities for the study. The principal investigator is listed on the Basic Information page and does not need to be included here.

Withdraw: Choose this when your submission is in the Pre-Review stage but you want to make additional edits before an IRB coordinator is assigned to your submission.Once a submission is in Pre-Review, the study team can no longer make changes, unless it is returned to the Pre-Submission stage (using the Withdraw function) or clarifications have been requested by the IRB coordinator. Withdrawing your submission to make additional edits will affect your spot in the queue.

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?

We have removed the May 1, 2024 deadline to populate study records to reduce burden on our research community. However, a modification to complete the population of the study record can be created at any time, but we strongly recommend submitting the Modification as soon as possible. The IRB cannot approve any new changes to the study or submit Reportable New Information (RNI) without completing this first modification to populate the study record. This means if an investigator would like to add new measures to their study or submit RNI, a modification to upload all study documents to the study’s record must be submitted and approved prior to requesting new changes to the study or submitting RNI.

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.