Albert Einstein Health Network will be transitioning all IRB studies from Cayuse to the Jefferson Enterprise IRB platform called iRIS. We are excited that all researchers in the Jefferson Enterprise will be submitting via the same online platform.

This communication describes signatory requirement for Einstein IRB applications.

Please see the 2nd communication sent to the Einstein Research Community regarding the transition to iRIS. 

As Jefferson has expanded, IRB activities have been unified into a single office and system. This makes it easier to register and provide oversight for studies across Jefferson sites, including Einstein. 

New IRB studies: We understand that you may already have new study applications under way with Einstein IRB in Cayuse. For these, you should proceed as normal, but please note that any submission that has been drafted or previously submitted but not approved, must be submitted and approved in Cayuse prior to January 14, 2023.   

Any submission that has not been submitted and approved in Cayuse by this date will not be accepted in Cayuse and will need to be submitted in iRIS. No new studies will be accepted by Einstein IRB after January 14.

Existing studies approved by the Einstein IRB will be transitioned to iRIS in late February following the last Einstein IRB meeting on February 17. Look for future communication on the go-live date for active Einstein studies. On that date, all prospective transactions for existing studies should be submitted in iRIS.

Following the meeting on February 17, the Einstein IRB will be deactivated and all research conducted at Einstein will be reviewed by the Jefferson Enterprise IRB going forward. After this date, Einstein IRB staff will no longer be available and all questions should be directed to the Jefferson Office of Human Research. You can find our contact information here.    

Access to the system is gained with your campus key and the password you use for all Jefferson applications such as email. 

All PIs and users who will need access to the system to create and check status of applications and access study documents must complete the iRIS training module. This is available in your myLearning account in myJeffHub. Co-investigators and key personnel identified on a study who will not need acces to iRIS do not need IRIS training.

iRIS training is required for all study team members who will complete tasks within iRIS--this includes all coordinators, investigators, and administrators. Please allow 24-48 hours for JCRI to activate your account.

CITI training will not change. All staff listed on a study must affiliate with Jefferson and complete the following courses:

1. Biomedical and/or Social Behavior (depending on the type of research you are conducting) 
2. Good Clinical Practice
3. Conflict of Interest training modules via CITI. 

More information on CITI Training can be found under Training & COI

To ensure iRIS receives your training:

1. Go into your CITI account to confirm that you have affiliated with Jefferson. This will give you access to the Jefferson menu of training modules. If you are currently certified under Einstein’s CITI requirements, these will remain in effect until they expire, at which point you will come under Jefferson training requirements.
2. Einstein researchers are required to complete the Conflict of Interest (COI) module in CITI.   

If you have completed training previously and updated your affiliation to Jefferson:

1. The curriculum page will open. 
2. Scroll down to Q4 and select the COI that pertains to you. 
3. Click the link and the course will post to your Jefferson CITI account. 

If this is your first time you are completing training, you may need to manually add this module to your Jefferson account. 

1. Scroll to Learn tools for Thomas Jefferson University. Click Add a Course. 
2. Scroll down to Q4 and select the COI that pertains to you. 
3. Click the link and the course will post to your Jefferson CITI account. 

Be sure to complete the 2-question survey following completion of iRIS training. This will capture the email address associated with your CITI account, which we will add to your iRIS account. (CITI feeds into iRIS based on email address.)

The DUO app is used by all Jeffersonians to gain access to Jefferson systems requiring log-in. If you do not currently have DUO installed on your phone, go to the app store and download it (it's a green app). You will need to go through a short setup process to verify your identify. Then, when you go to log-in to iRIS, the system will verify your identify by either sending you a text or calling you with a temporary password which you type into the DUO log-in screen on your computer. Once your identify is verified, you can then proceed to iRIS to log-in using campus key and password.

IRIS is a fully web-based system that handles IRB submission, document storage and other functions. The system was implemented by the Jefferson Enterprise in September 2022.

As of February 18, 2023, the Einstein Cayuse IRB system will be limited to read-only access and will be maintained for the forseeable future. You will be able to access your legacy study records and associated electronic documents in Cayuse. Going forward, all IRB applications for new and existing studies should be made in the iRIS system.

For studies currently approved by the Einstein IRB, you will need to submit a new study application in iRIS to establish the study in the system. This is purely an administrative process, and your application will not receive another IRB review. Once you receive email acknowledgement that processing is completed, you can submit transactions for the study in iRIS (e.g., amendment, continuing review, etc.).

In iRIS, the submitter will designate who will sign off on applications. The submitter is responsible for identifying the appropriate signatories.  This is typically the local departmental chair and the departmental administrator.

iRIS can be accessed from anywhere in the continental Unites States where you have internet access 24 hours per day, 7 days a week. If you are accessing iRIS while on the Jefferson network, you will only need to use your campus key and password to sign in. If you are accessing iRIS from a personal device or outside the Jefferson network, you will to use Two-Factor Authentication via DUO. See instructions above for activating DUO. 

iRIS can be accessed directly via the URL jefferson.imedris.net. 

Einstein personnel should continue to adhere to the Einstein COI policy requiring that your COI disclosure be reviewed by the Einstein COI committee. If any management of the COI is required, this information will be forwarded to the Jefferson Enterprise IRB for due consideration.

Please stay tuned for future announcement about the new COI administrator for Einstein who will succeed Beth Lynch.

Our office hours are 9-5, Monday-Friday.

Walter Kraft, MD
Director, Office of Human Research
215-503-0203
Walter.Kraft@jefferson.edu

Kyle Conner, MA, CIP
Associate Director
Office of Human Research
215-503-8966
Kyle.Conner@jefferson.edu