See the iRIS Account page for detailed information on obtaining an account.

iRIS is accessible via MyAccess. Click the "IRB - iRIS" link. The use of is VPN no longer required or recommended for off-campus access.

If you need access to particular studies within iRIS, review the next FAQ, "How can I be added to a study?"

If you are Key Study Personnel, a current member of the study team must submit a modification to request that you be added to the study.

If you are research support staff or a study contact who is not Key Study Personnel, you are not required to submit a modification to be added to the study.

The IRB may grant special departmental access to department MSOs, department Research Finance Administrators or other individuals who can justify needing this type of access.

Follow these instructions. After you receive this access, you will have read-only access to all studies that are being done in your department(s). You will be able to access copies of approval letters via Submission History, view the IRB Application to see which funding sources and personnel are on the study, or print or save copies of the IRB Application, consent forms, etc.

The current version of iRIS is compatible with all browsers. Turn off the web browser’s pop-up blocker for the iRIS site.

• If you receive the pop-up error message 'blockUI requires jQuery v.1.2.3 or later! You are using 1.11.1,' clear the cache in your browser
• Consult with your Desktop Support analyst regarding which version of browser you should use based on the applications you access. 

No, Sponsors are not granted access to iRIS and should request documents through the study team.

Both MyAccess and iRIS will automatically log you out if you are inactive in the system. As such, we recommend that you save your work regularly.

Interactive Tutorials: Go to the  iRIS Help website (MyAccess login required) to take these tutorials. 

• Introduction to the IRB Process
• iRIS 101: Homepage Orientation & Finding your IRB Forms & Documents
• Submitting a New IRB Study
• Making Changes to Approved IRB Studies
• Responding to Linked Stipulations from the IRB

Quick Guides – These PDF quick guides that contain step-by-step instructions and screenshots. They are available on the iRIS Help website or within iRIS by clicking on the Help button in the right-hand corner.

Submission Instructions – The Submissions section of our website has instructions and guidance on entering new studies and other submissions in iRIS. 

Application Help Links – If you get stuck answering a question in iRIS, hover over the help bubble next to the question and then click on the link that appears for Instructions and/or Guidance.

iRIS Application Outlines – The outlines include all potential sections you may need to complete and can be used as guides. They are available in the Help section in iRIS.

Training Classes –The IRB offers several in-person training sessions. Registration is required. 

Contact Us – You can contact our office at (415)476-1814 or [email protected].

Here are just a few of the benefits that the iRIS system offers to investigators and their support staff:

Faster review process and communication of status – Electronic submission will reduce processing time and speed up the time to approval. PIs and study contacts will receive approval letters by email immediately after they are prepared.

Study information at your fingertips – Where you have Internet access, you have access to your protocol information.

Improved document management – The system identifies which documents are currently approved, helping you use the correct versions.

Intuitive application – The IRB Application will branch out based on how you answer key questions, so you won't have to figure out which supplements to submit.

Documentation of submission for sponsors – You will have a record of each document that you submit.

Easier access to IRB approval records – Study approval records will be accessible to PIs, study staff, and key departmental administrators.

Environmentally friendly – Prior to the implementation of iRIS, the IRB received about 5 million pieces of paper each year. The electronic system has helped us eliminate this waste and supports UCSF's efforts to incorporate environmentally-friendly practices across campus.

iRIS has been implemented as a Closed System at UCSF, consistent with 21 CFR Part 11. Every user of the system must be individually authenticated and specifically authorized to gain access to the system. Additional levels of control and authorization are required before users can carry our specific functions within the system (e.g., to submit, review and/or approve research).

Users must log into the system through a secure portal which the University monitors, and users are required to use both a unique ID and a password to gain access the system.  Users are required to protect and keep confidential their IDs and passwords and follow all University information security policies. Users are responsible for the actions, certifications and determinations they make while logged into the system. Actions within the system are recorded and time-stamped. Study and system records are available for review in both printed and electronic format.

Yes. Only the following types of submissions should be submitted via paper, not in iRIS: Emergency Use Requests and Administrative Reviews for Human Research Studies Not Being Conducted by a UCSF PI But Accessing UCSF Facilities, Patients or Personnel.

Information on entering new studies is provided in the New Study page. 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 as little as 30 minutes for a chart review study to several hours or even several days for a complex study. Before you enter your study, review our guidance on submitting new studies. Also, review the factors that may affect the time it takes to enter a study to learn how you can prepare to submit your study: 

How complex is your study? – The iRIS applications build and branch based on how you answer key questions, so the applications for complex studies usually have more sections. 

Are you prepared to answer all of the questions in the IRB and/or GESCR Applications? – Look over the iRIS application outlines to see which questions you may be asked to answer. Contact members of your research team or the study sponsor for help. If your study is being funded through UCSF, be sure to ask your Research Services Analyst (RSA) for information about the funding source, including the RAS proposal or award number.

Do you have access to all of the supporting documents you need to attach? – Go over the Initial Submission Checklist to determine what attachments you need to submit.

Is the PI available to sign off on the study? – The PI must electronically sign off on the initial review, so factor in the PI’s availability if you are not the PI of the study.

Yes, use the iRIS application outlines as guides to see which questions you may need to answer in the electronic application(s). The outlines are available in the Help section in iRIS. Some sections of the applications are only required if your research has certain characteristics.

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 at (415) 476-1814.

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. 

The iRIS system sends correspondence pertaining to submissions and reminder notices for Continuing Review to the PI and Study Contacts. If your study has a Co-Principal Investigator or a supervising or mentoring Investigator (for Resident, Fellow, and Post-Doc PIs), please add them as Study Contacts to ensure they receive study-related correspondence.”

Submission tracking is incredibly easy in the iRIS system.

• 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.

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 assigned analyst for more information.

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. Contact us at (415) 476-1814.

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 IRB 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 assigned IRB analyst 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: 

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 top 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.

After the study is approved, get the approved consent form translated and submit it via a Modification Form.

Click on the Help icon within iRIS or visit the iRIS Help website and read the quick guide "Responding to Requests for Submission Correction." Also review the Responding to Stipulations in iRIS section of 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, review the guidance in the appropriate section of the Submissions section of 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.