iRIS Online Application FAQs

• To access the online submission system, go to: byu.imedris.net.
• More instructions can be found here: https://irb.byu.edu/how-to-access-iris-for-the-first-time.
• To add external researchers please see: https://irb.byu.edu/how-to-add-external-researcher.

iRIS will automatically log you out if you are inactive in the system. Please click on the “save and continue” button (in the upper right corner) regularly; especially when you plan to be away from your computer.

Yes, all IRB submissions must be submitted via iRIS including initial submissions, modification requests, continuing reviews, adverse event reports.

Information about the application can be found on the Application Resources and Help page under "The Application". The online IRB Application form uses branching technology, and certain sections of the form will automatically appear after you answer key questions. You do not need to navigate through sections of the IRB Application that do not apply to your type of study.

It may take a little as 30 minutes for a chart review study to several hours or even several days for a complex study. Also, review the factors that may affect the time it takes to enter a study to learn how you can prepare yourself to submit your study

Once your application is submitted to the IRB, it is locked and becomes part of the official study record. You will need to add a revision in order to edit it.

You also may be unable to edit and/or save changes if you are looking at the application in “Entire View.” Switch to “Section View” in order to edit.

Most likely, you have not lost your work. Instead, you have either: a) changed an answer that affects the way the form branches or b) finished the application and entered the Initial Review Submission Packet.

Branching Change: Changing some answers will affect the way the IRB Application branches. Sometimes section links will disappear from the left-hand menu of the form. You have not lost any work – data you previously entered is still there, but new sections may have been added to the form. You must click the "Save and Continue to the Next Section" button through each page to rebuild the form before you can submit it. Also be sure to answer any new questions.

Entering the Initial Review Submission Packet: The last section in the IRB Application is labeled “End of Study Application.” Unless you need to complete the GESCR Application, you will automatically enter the Initial Review Submission Packet after you click “Save and Continue to the Next Section” on this page.

The Initial Review Submission Packet is a separate form in which you will add a lay study summary, list special processing instructions, and attach consent forms or other study documents. The application you just completed also will be automatically attached here. The Initial Review Submission Packet bundles all of the components of the submission together, kind of like stapling a paper packet.

If you need to get back into the IRB Application to edit or check your work, you can get there by one of two ways:

Option #1: Section 2.0 of the Initial Review Submission Packet

• The IRB Application is attached in section 2.0 of the Initial Review Submission Packet, so you can get to by following these steps:
• Answer the questions in section 1.0 of the Initial Review Submission Packet.
• Click “Save and Continue” in section 1.0.
• Click the Edit/View icon next to the application. This will take them back into the application form.
  

Option #2: Study Mgmt Link in Navigation

• Click on the “study mgmt.” link in the Navigation list (beneath your account name and department).
• You will then see the study dashboard. The link to the application is on the left-hand side of this page. Click on the link and then click the "Edit/View" button next to the correct version.

If neither of these two scenarios match your situation, contact the IRB office.

When you click on the My Studies button from your home page, you will see a list of your studies. Next to each study, you will see a Copy button. This button will copy the Application for that study. It will not copy the attachments.

You can copy a study that is incomplete and in draft status or a study that has been submitted. Some users have created a IRB Application template that they never submit, and they instead copy that template each time they begin to submit a new, similar study.

Note: If you copy a study, the copy will not be assigned a study number until you submit it. Please remember to update the study title in section 1 of the Application.

Anyone can fill out the study application, but the PI must sign off on and submit a new study. The PI must also sign off on and submit the Continuing Review Form. All other study submissions can be submitted by investigators, research support staff or study contacts who are listed in section 3 of the IRB Application.

Important Note: Only individuals listed in section 3 of the IRB Application will have access to the study (via My Studies) after it is submitted. If you are not Key Study Personnel but need access to the study, be sure to add yourself as a study contact.

Study contacts are copied on all important email notifications that the PI receives, including requests for submission corrections, approval letters and continuing review reminders. You can add as many study contacts as you’d like in section 3 of the IRB Application.

Submission tracking is incredibly easy in the iRIS system.

You will be able to see which IRB panel received the submission and which IRB analyst has been assigned to process the submission. If the submission has been assigned for review, you also will be able to see that information. You can contact the IRB office for more information.

• Go to the My Studies section and open the study.
• Click on the "Submission History" link
• Locate the submission you want to track, and click the Track Location icon.

In the workflow tracking, you should see a note that says, "IRB Committee XX Panel received the submission." If you do not see this note, the IRB may not have received the study and you should contact the IRB office.

The overall study has a status in iRIS. Here are what these statuses mean and some important notes about the statuses. You can also check the Submission History if you need more detail about where the study is at in the review process.

Important Notes About Study Statuses

• The study status automatically updates from "Draft" to "Pending – Submitted for Initial Review" once you submit the study to the IRB. The status will also automatically change to "Expired" once the expiration date is reached the the study has not been renewed. The CHR manually updates all other statuses according to the type of study and where it is in the review process.
• Only studies with a "Draft" status can be deleted by the study team. If you need to delete a study that has already been submitted, contact the IRB and request for the study to be withdrawn.
• If the study status is green, the study is Active and can be conducted as described in the application. The only exception is for pending modifications — the IRB must approve the modification before the change can implemented. Pending modifications do not change the overall study status.

Study Statuses:

The iRIS system automatically assigns a 7-digit number to your study. The first four digits represent the year in which you first submitted your study in iRIS. The study retains this 7-digit number for its life.

After you submit an initial review or post-approval form (e.g. the Continuing Review Form), that submission is assigned a unique reference number. If the IRB sends the submission back to you for corrections, the response you submit back to the IRB via the Review Response Submission Form will be assigned the same reference number as the original submission. This number will help you figure out which submissions (original or responses) are linked.

You can find the reference number in the Submission History. You also can open the study via My Studies, click on the name of the form you submitted (e.g. Initial Review Submission Packet or Modification Form) and see the reference number there.

The searchable sponsor list in iRIS is a copy of the master list of BYU sponsors. Some sponsor names have been abbreviated, so search for keywords in the sponsor's name. If you are unable to find your sponsor, contact the IRB office.

You will be asked to provide the following information about each of the study’s funding source(s). If you do not know how to answer some of these questions, contact the administrator who handles this study's funding.

Sponsor Role: Clarify what role the sponsor has in the study, including funding, protocol control, data coordination, monitoring, auditing or passthrough (e.g. BYU has received the funding, but no human subjects research will take place at our site).

Awardee Institution: Clarify if the funding is coming through BYU or an affiliate institution. Note: If BYU has a subcontract with another institution, select BYU here.

Is the Institution the Prime Grant Holder? Clarify if the main grant is held by an investigator at our site or by an investigator at another institution.

Contract Type: Clarify if the funding type is a cooperative agreement, contract, drug/device donation, fellowship, grant, subcontract or unfunded research collaboration.

BYU Proposal and/or Award Number: These numbers are available in the BYU Kuali Research System for every contract or grant administered by the BYU Sponsored Projects Office.

Important Notes: If funding has already been awarded or the contract is being processed by the BYU Sponsored Projects Office, you will have a proposal and/or award number. Check with your Sponsored Projects Administrator if you are unsure of your number.

Grant-specific Information:

Grant Title: List the grant title if it is different from IRB Application title.

PI Name: List the PI of the grant if this individual is not the PI of the IRB study.

Explain Any Significant Discrepancies From the IRB Application: Clarify if the research described in the grant does not match the research described in the IRB Application and why the two descriptions differ.

Whenever possible, the IRB recommends consenting study subjects using the stamped version of the consent document. Doing so will help confirm that you are using the currently approved consent form.

Please leave a 1.25" margin at the bottom of each page of the consent form to accommodate the approval stamp.

No, turn off tracked changes before uploading your consent form.

iRIS includes an internal document comparison tool. You and the IRB can use this tool to see what changes were made in different versions of the consent form if you submitted MS Word documents.

To use this tool, open your study via My Studies. Click on the “Informed Consent” link from the study management dashboard. Click on the folder icon to see all of the versions of a particular consent document. Check the boxes next to the two versions you want to compare, and then click “Compare Consent Versions” button.

The comparison tool can also be used to compare different versions of the IRB Application, submission forms (such as the Modification Form) and Word versions of Other Study Documents.

The comparison feature does not work with PDFs, so upload a Word document whenever possible.

These items are considered to be consent documents, so please attach them in the “Consent Documents” section of the Initial Review Submission Packet. Exception: For exempt studies, upload these documents in the "Other Study Documents" section.

Upload the translated consent form and use the drop down menu to select the language.

iRIS version numbers include two digits, such as version 1.0. You can modify the first number, but the number following the decimal point is hard coded and cannot be changed.

Each time you add a revision to the document or form, the second part of the number will change: e.g. version 1.0 becomes version 1.1. You can update the first part of this number, if you wish.

You also are able to assign a version date to consent forms and study documents. You can use any version date that you would like. However, we recommend that you update the version date when you revise the document.

You can access your approval letter by logging into your iRIS account and selecting the study.

The BYU approval letters issued via iRIS are not signed by a member of the IRB. However, these letters and other available information comply with all regulatory requirements. In addition, iRIS is compliant with FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures).

Click here to read the "Responding to Stipulations" guide on our website.

1. Go to My Studies and open your active study.

2. In the Submission Forms section of the study submissions dashboard, click on the name of the form that you want to submit.

3. Click on the Add New Form button to start the form.

For information on how to complete the individual forms, click here to review the guidance on our website.

Yes, you can delete a form if the IRB has not started processing it yet.

1. Go to My Studies and open your study.

2. If necessary, retract the submission you want to delete by clicking on the "Retract Submission" button and then click OK.

3. In the Submission Form column, click on the name of the form you want to delete (i.e. Modification Form).

4. You will see a list of forms you have submitted. Check the box next to the form you want to delete and click the "Delete Selected Form" button.

Yes. Open the form and click on the "Printer Friendly" button. You can then choose to print the form as an HTML form or a PDF form. Select "PDF Form" to save the form as a PDF.