iRIS Frequently Asked Questions (FAQ) | Office of Human Research Affairs (2024)

Below is a list of Frequently Asked Questions, divided into the following sections:

Logging In

What internet browser(s) can I use?

iRIS is compatible with most browsers. The preferred browsers are: Internet Explorer 9.0+ and Safari 6.0+. Chrome (30.0+) and Firefox (24.0+) are also supported. Browser notes:

Internet Explorer (all versions): To ensure all (external) links work: Go to "Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK"
Note: Users at Montefiore whose computers only have IE 8.0 or earlier may contact the EHIT helpdesk to request that Firefox be installed on their computers.
Firefox (all versions): To ensure all (external) links work: Type "about:config" in the address bar. Click "I'll be careful, I promise!" On the search menu, type "mixed". Change the value of "security.mixed_content.block_active_content" to "false".
Internet Explorer 7.0 and 8.0: There is a known incompatibility that affects users at Montefiore.
Internet Explorer 10.0+: If you encounter problems, try compatibility mode.
Safari: Built in pop-up blockers prevents various windows from loading (with no warning). Disable the pop-up blocker (instructions) or use another browser.

What is an internet browser?

An internet browser is the program you use to access web pages (typical examples include Internet Explorer, Firefox, Safari, etc.).

How do I gain access to iRIS?

You must log into iRIS with MMCAD credentials. After logging in the first time, email the following information to iris-support@einsteinmed.org to have your iRIS account activated:

Your full name
MMCAD username
Institution (e.g. YU/Einstein, Montefiore or NBHN)
Academic department (and for the Department of Medicine, division name)
Status (e.g. faculty, staff, or student)

Do I have an MMCAD username? What is it?

Generally Einstein faculty, Einstein employees, Einstein students and Montefiore affiliates already have MMCAD accounts. An MMCAD account is the Einstein/Montefiore user ID used to access Kronos, Banner, Montefiore email, Montefiore portal, or EPIC.

What's my MMCAD password?

If you've confirmed you have an MMCAD username but don't know your password, contact the Einstein/Montefiore service desk at 914-881-4554.

How do I change my MMCAD password?

If you have an Einstein/Montefiore email address, you may change your password in OWA (tutorial). Alternatively you may contact the Einstein/Montefiore service desk at 914-881-4554. Contractors and volunteers with MMCADs should also contact the Einstein/Montefiore service desk for password changes.

How do I add/update my email address?

Einstein, Montefiore and YU employees, faculty, students and affiliates must use their institutional emails, you may not change the email address in your account. For all other users, you may contact the Einstein/Montefiore service desk at 914-881-4554 to request that they open a ticket with IT Security to update your email address in the 'mmcYUemail' attribute field. After the service desk reports that your email address has been updated, you'll need to log into iRIS to have the update reflected there.

How do I login if I don't have an MMCAD username? (Also: How do I add Key Personnel if they don't have MMCAD usernames?)

You will need to obtain an MMCAD username. Emailiris-support@einsteinmed.orgto request an MMCAD. Please note requests typically take 5-10 business days to process.

• If you are a faculty member, researcher, or an employee of Montefiore, you do not need to request a user ID for iRIS. Use your Montefiore user ID and the password you use for EPIC or Montefiore Email. Once you have logged in, email your department/division name and your request for account activation to iris-support@einsteinmed.org .

• If you are an Einstein staff member or student, you DO NOT need to request a user ID for iRIS. Einstein staff and students can login using their Einstein user ID and password. Staff members should use the user ID and password used to login to Kronos or Montefiore Portal. Once you have logged in, email your academic department/division name and your request for account activation to iris-support@einsteinmed.org .

**If the sections above do not apply to you e-mailiris-support@einsteinmed.org for further instructions.

What's the address for iRIS?

https://iris.einsteinmed.org

General

How do I access the iRIS handbooks?: The iRIS handbooks are available for download by clicking the "Help" link in the upper-right corner of iRIS (after logging in).

How come some of the "Help" menu links don't work?: If you're using Internet Explorer, you will need to make the following change in your IE security settings in order for our external links to work:"Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK." If you encounter this problem in another browser, contact us.

Submission

When is an IRB # assigned?

IRB #s are assigned once an application is started and are visible in the top-left corner of the screen. The format is YYYY-NNNN (4-digit year followed by a 4-digit number).

What IRB procedures have changed?

Topic	iRIS	PATS	Paper
COI	Research specific disclosures are no longer required. Instead a recent (filed within the past 6 months) general COI disclosure must be on file with the Einstein COI administrative office. This requirement applies to the PI and Additional Investigators only (no COI disclosure is required for Research Support Staff). Instructions on how to file an electronic COI disclosure are available here.	Paper COI forms were required for each KP with each submission.
CITI	All KP must have completed the education requirement prior to submission to the IRB. New KP should ensure the preferred email address in their CITI account matches the one in their iRIS account. (Applications submitted without all KP having completed the education requirement will be automatically stopped by iRIS. The application will need to be retracted and resubmitted after the education requirement is satisfied by all KP. In addition, effective January 1, 2014, iRIS will enforce the COI department's requirement that all Key Personnel also complete the CITI COI course.
Key Personnel	"Key Personnel" in categories (PI, Additional Investigators, Research Support Staff, and administrative contacts).	"Key Personnel" were all listed together.
Delegates	Delegates are assigned as "administrative contacts" (bottom of Section 3) on a protocol-by-protocol basis within the application.	Delegates were assigned by the IRB (with permission of the PI) on a PI-basis (once assigned as a delegate, the individual had access to work on all of a PI's research projects.	N/A
Progress Report Notices	Email sent by iRIS to the PI and administrative contacts.	Email sent by PATS to the PI and administrative contact.	Email sent by IRB staff to the PI and research staff known to the IRB.

What does all the new terminology in iRIS mean?

iRIS	PATS	Paper
Project Contact (in addition to KP)	Delegates	N/A
Reportable Event	Adverse Event
Reportable Event	Deviation

My protocol was submitted in iRIS but I haven’t heard anything yet from the IRB. What has happened?

You can always check the status of your protocol by clicking on the “My Studies” link in iRIS. Refer to page 46 of the Researcher’s Handbook (available for download from the iRIS help menu) for further guidance. However, there are three things that must happen before your protocol is received by the IRB:

All designated signatories (usually the PI and his/her department chair) must approve the application. They will need to log in to iRIS to do so. Please note that the application does not need to be sent to Other Investigators or Research Support Staff.
All Investigators must have an electronic COI disclosure on file.
All KP must satisfy the human subjects research education requirement.

How can I check the CITI status for all of KP on my study in iRIS?

To see the education history and e-mail addresses for all KP on the study follow these instructions:

To find the study, log in to iRIS, click on Study Assistant (on the left side of the screen), then on My Studies.
Select your study by clicking on the notebook icon on the left under "Click to open."
Click on "study mgmt." in the "Navigation" section of the header.
Click on the Study Management tab (on the upper left).
Click on Study Summary/Profile.
Click on the head icon next to each study personnel. The CITI status is under Education History. If the Education History is blank or only has expired courses, the KP will NOT pass the CITI check in iRIS.

Note that CITI status is synchronized via the e-mail address in iRIS (which is imported directly from MMCAD). The e-mail address is under Contact Information on this page. Click the “Back” button (upper right) to return to the Study Summary/Profile page.
Note that CITI status is checked for all study personnel unless they are ONLY listed as Study Contacts.

What are the deadlines for iRIS submissions?

Exempt and Expedited applications and their associated transactions are reviewed upon receipt. Full review submissions must be received by the IRB by the published deadlines. Full review submissions received after the deadline may be accepted on a case-by-case basis.

How do I obtain approvals/signatures?

iRIS uses electronic signatures. Upon completing your application you'll need to route it for approval to the PI and other appropriate individuals (see here for a complete list). Detailed instructions are available in the researcher handbook (available for download within iRIS) beginning on page 43.

Applications

I want to apply for a grant (on a new protocol) ... what do I do?: Follow our current procedure (which can be found here).
How do I submit a protocol, advertisem*nt, etc.?: All project materials (consent forms, protocols, advertisem*nts, etc.) must be attached to an appropriate transaction in iRIS.

Migration

How does migration work?: See our Migration Information page.

Informed Consent Documents (ICDs)

Where can I find the Informed Consent Templates?: Template incorporating HIPAA Authorization language are available within iRIS and also here.

Progress Reports (PRs)

I used to be able to include certain changes to my application (e.g. adding or removing Key Personnel) in my PR. How do I do that now?: Any and all changes to the Application/Protocol must be done through an Amendment.
Last year's PR would be helpful in completing this year's. Where can I get a copy of it?: Prior PRs are not being converted to iRIS. However if you've previously completed a PR in iRIS, you can access it through iRIS.

Amendments

My study is already under review and I have changes to make. Can I start an amendment?: You should not begin an amendment until your initial submission is approved.
How do I add KP to my approved protocol?: An amendment is required.

Still have questions? Ask us!