Below is a list of Frequently Asked Questions, divided into the following sections:
Logging In | General | Submission
| Applications | Conversion
| Informed Consent Documents | Progress Reports
| Amendments
Logging In
- What internet browser(s) can I use?
- iRIS is compatible with most browsers. The preferred browsers are: Internet Explorer 6.0, Internet Explorer 8.0-9.0, Firefox 2.0+ and Safari 3.0+. (Note: There is a known incompatibility with Internet Explorer 7.0. Internet Explorer 10.0 isn't officially supported yet, but appears to work in compatibility mode.)
- 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 YUAD credentials. After logging in the first time, email the following information to iris-support@einstein.yu.edu to have your iRIS account activated:
- YUAD 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 a YUAD username? What is it?
- Generally Einstein faculty, YU/Einstein employees, and YU/Einstein students/alumni already have YUAD accounts. You can look up your YUAD username (and determine if you have YUAD credentials) using this tool (no SSN required) or this tool (SSN required).
- What's my YUAD password?
- If you've confirmed you have a YUAD username but don't know your password, contact the YU ITS helpdesk at 212-960-5294 or helpdesk@yu.edu.
- How do I change my YUAD password?
- If you have a YU or Einstein email address, you may change your password in OWA (tutorial). Alternatively you may contact the YU ITS helpdesk at 212-960-5294 or helpdesk@yu.edu.
- How do I log in if I don't have a YUAD username?
- You will need to obtain a YUAD username. Email your full name, department, office phone, and email address to iris-support@einstein.yu.edu. Please note this process takes 1-2 business days.
General
- How do I access the iRIS handbook?
- The iRIS handbook is available for download by clicking the "Help" link in the upper-right corner of iRIS (after logging in).
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 90 days) 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. Note: You can (and should) check the date of COI disclosures using the "Individuals with COI Disclosures on File" link in the Help section of iRIS. |
Paper COI forms were required for each KP with each submission. |
| CITI |
All KSP must have completed the education requirement prior to submission to the IRB. New KSP should ensure the primary email address in their CITI account matches the one in their iRIS account. (Applications submitted without all KSP 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 completed by all KSP. |
|
|
| Key Personnel |
"Key Study Personnel" in categories (PI, co-investigators, other study personnel, administrative contacts). |
"Key Personnel" were all listed together.
|
| Delegates |
Delegates are assigned 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 |
| Key Study Personnel (KSP) |
Key Personnel |
| Project Contact (in addition to KSP) |
Delegates |
N/A |
| Reportable Event |
Adverse Event |
| Reportable Event |
Deviation |
- My protocol was submitted on 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 co-Investigators or other research personnel.
- All KSP must satisfy the human subjects research education requirement.
- All Investigators must have an electronic COI disclosure on file.
- What are the deadlines for iRIS submissions?
- Exempt and Expedited applications and their associated transactions are reviewed upon receipt. Full review submissions aren't being accepted in iRIS at this time.
- 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, advertisement, etc.?
- All project materials (consent forms, protocols, advertisements, etc.) must be attached to an appropriate transaction in iRIS.
Conversions
- How does conversion work?
- TBA
Informed Consent Documents (ICDs)
- Where can I find the Informed Consent Templates?
- A new template incorporating HIPAA Authorization language is now 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
- How do I add KSP to my approved protocol?
- An amendment is required.
Still have questions? Ask us!