HSPP- April- May-June, 2020- Newsletter

The Integrated Research Information System (iRIS ) is the electronic system used by research personnel and the Institutional Review Board (IRB) for the submission and review of research projects involving human participants. On March 21, 2013, iRIS was successfully implemented. To support said implementation, one on one training of researchers as well as weekly group sessions were carried out. These training sessions are still available to all investigators as are iRIS-training manuals. To schedule a training session e-mail Mayra Cagganello (cagganello@uchc.edu). To obtain a training manual click on the Help button found in your iRIS Homepage.

This present Newsletter has been prepared to address the most common and current difficulties observed when investigators navigate the system. In the majority of the cases, these difficulties have caused delays in approval. In addition to the training options noted above, it is highly recommended that all iRIS users read this newsletter to increase knowledge of the system thus preventing delays in approvals.

The Most Common Mistakes with Revisions of Documents in iRIS

Once a submission is received by the IRB in iRIS, an IRB Regulatory Specialist (RS) conducts a pre-review of that submission. If the RS determines that corrections or additional documentation is needed before the submission can be formally reviewed by the IRB, the RS will return the submission to the study team either in a Submission Correction Form or in a Submission Response Form describing the corrections that are necessary.

The following section describes the major issues observed when investigators are submitting revised documents in the above mentioned submission forms.

Issue #1: Investigators upload revised documents to the system section for Protocol items rather than to the Submission Form .

The corrections requested must be made within the Submission form sent by the IRB (e.g., the Submission Correction Form or the Submission Response Form). The IRB does not have access to your Study’s Protocol items. The IRB will only see and review documents uploaded/attached to the Submission Forms.

Issue #2: Investigators upload edited documents to the Submission Form as brand new documents instead of creating an iRIS revision.

If a contingency requires you to revise a document that you have submitted in previous rounds, you should follow the steps found in the iRIS User Manuals to revise the documents that are in the system.

If you have received a Submission Correction Form, please use the instructions found in the iRIS User Manual titled: Responding to a Correction Task- Manual 3.
If you have received a Submission Response Form, please use the instructions found in the iRIS User Manual titled: Responding to a Response Task – Manual 4.

iRIS Sign –off Notifications

Once a submission form has been routed for sign off, the iRIS system generates emails to notify the research team members and principal investigator that they need to log into iRIS and apply their sign off.

Depending on whose signature is required, the e-mail sent to the study team members will have a different message.

Below are two possible messages the study team can receive when sign off are required. The subject line of the notification indicates who needs to sign off.

A “Protocol Sign-off Notification” is sent to all members of the study team with a subject line stating: Member of Research Team – Initial Notification for Review and Signoff. In this case, all members of the study team need to log into iRIS and sign off (e.g., an initial submission application form).

The body of the email will specifically state that the study is in need of signatures from one or more team members of the team in order to continue the submission process to the IRB.

A “Principal Investigator Signoff Notification” is sent to all members of the study team.
However, the subject line indicates that this is a Principal Investigator Signoff Notification. In this case, the submission has been routed only to the Principal Investigator for sign off (e.g., a Response form, an initial Modification Form, Continuation Form, Problem Report Form, and Closure Form,). Even though the PI sign off is the only one required, all study team members receive the notification so that they are aware that the PI needs to do so.

The body of the email will state PI Signoff Needed.

Investigators should review the content of the notifications to determine whether to log into iRIS to sign off. Many investigators log into iRIS with the intention to sign off on a submission, however, their signatures are not required.

iRIS Frequently Asked Questions (FAQ)

Q: Who needs to request an account to access iRIS?

A: If you are affiliated to UConn Health (e.g., if you are a student, a resident, a fellow, a faculty member, or staff), by virtue of said affiliation you already have the ability to log in to iRIS. Your UConn Health network’s credentials are to be used to log into iRIS.

Individuals who are external to UConn Health (e, g., a UCONN Storrs student or faculty, a Hartford Hospital physician, etc.) who need access to iRIS should request an external account in iRIS. An online request form must be completed by clicking on the Request New Account option found in the iRIS logging page. The person requesting the account should provide an explanation as to why the account is necessary and with whom at UConn Health the researcher will be associated.

An email request to create an account in iRIS is not adequate to generate an account in iRIS. The information provided in the on-line request form is necessary to build an account for an external user. To avoid inaccurate information this online request form should be completed by the person in need of the account.

Q: I am unable to log into iRIS. What should I do?

A: Internal Users (Investigators Affiliated to UConn Health): If you are having trouble accessing iRIS with your UConn Health network credentials, please try to verify the following prior to contacting the HSPP/IRB office:

Your network credentials are case sensitive. Check the basics such as cap lock or number lock issues.
Ensure that your UConn Health password has not expired (you can test this by rebooting your personal computer).
If you recently changed your password, please try rebooting your personal computer before logging into IRIS.
Make sure you are not coping and pasting your credentials into the iRIS’s log in boxes. Your user ID and password must be typed into the iRIS log in boxes.
If you are still experiencing problems using your UConn Health credentials, please contact the UConn Health help desk at x4400.

External Users (Investigators NOT Affiliated to UConn Health): If you are having trouble accessing iRIS with the credentials provided when your account was created, you do not need to request another account. Please, do the following:

The iRIS accounts of external users are active for a maximum of an 18-month period. If you have not used iRIS for a long time and you think your account has expired, send an email to Mayra Cagganello ( cagganello@uchc.edu ) requesting an extension of your account.
If your account is active ( is not expired) but you forgot your iRIS User ID, send an email to Mayra Cagganello ( cagganello@uchc.edu ) requesting your iRIS User ID.
If you know your iRIS User ID but can’t remember your password, you will need to retrieve your password from iRIS. To do so, click on the “I forgot my Password” tab found in the iRIS logging page . Enter your iRIS User ID in the box provided, and then click on the “Send Password” tab. The IRIS system will send your password to the e-mail address found in your iRIS account.
If you have tried to retrieve your password but have not received an email from iRIS with your password, it may be that your email address in your iRIS account is no longer valid. If you have a new email address, email your new email address to Mayra Cagganello ( cagganello@uchc.edu ) with a request to update your email address in iRIS.

Q: Who Needs to Sign off on Submissions in iRIS?

The table below explains:

Form	Who is Required to Sign
*Initial submission form* for a new study	All key study personnel identified on the application form, excluding those who are listed only as a contact person.
*Correction form*	Any member of the study team, most often the study coordinator.
*Response form*	The Principal Investigator (PI)
*Continuation Form*	The Principal Investigator (PI)
**Modification Form*	The Principal Investigator (PI)
*Problem Report Form*	The Principal Investigator (PI)
*Closure Form*	The Principal Investigator (PI)
When only the PI is required to sign the form on the routing sign-off sheet, the boxes next to the names of the other key study personnel should be unchecked. *When new personnel are being added to the study through a request for modification, they will be asked by the IRB to sign off as a contingency for approval.

When a Submission form is routed for sign off and other members of the study team are checked for sign-off, you should uncheck the boxes next to their names to deselect them as shown in the screen shot below. Likewise, initial continuations, modifications, problem reports and closure forms only require the Principal Investigator (PI) sign off. If other members of the study team are listed in the routing sign off sheet, you can uncheck the boxes to deselect their names .

Q: I am submitting a modification form to add new personnel to an approved study. However, when routing the modification form for sign off I am unable to find the name of the new investigators in the Sign off Submission Routing list.

A: When a Modification Form is created in iRIS, such form works as a “request” made to the IRB. Only principal investigators are required to sign off on an initial Modification Form.

When routing this form for sign off, the investigator working on the form will not find the names of the new personnel in the Sign off Submission Routing list. This is because this request will be granted after the IRB has verified that the new personnel has complied with the human subjects protection training (e.g., CITI Training) requirement. Moreover, the iRIS the system verifies whether the new added personnel has a valid iRIS account.

After the IRB staff and IRIS system have confirmed that the new personnel has met these requirements, an IRB Regulatory Specialist will add the names of the new personnel to the Key Personnel section of the study allowing the new investigator access to the study.

The IRB Regulatory Specialist then returns the Modification Form to the study team in a Correction Form with a contingency for approval. The contingency will require that the new personnel sign off to accept his/her role in the study. At this point, the study team working in the Correction Form will find the names of the new personnel in the Sign off Submission Routing list.

Q: I routed a submission form to the IRB a while ago. I have not hear from the IRB. I see that the track location of the form states that is “Waiting for Finalization of Routing List.” What should I do?

A: In order for a form to arrive to the IRB queue in IRIS, the person submitting the form must complete several steps to route the form for sign off. When all sign offs on the form have been completed, the system moves the submission form to the Submission box of the IRB in IRIS.

Whenever an investigator sees a yellow square under the “Track Location” that means that the form built in iRIS was never routed for sign off .

In the example below, the submission Correction Form is waiting for someone from the study team to route the form for signatures.

To route the form to the person who has responded to the contingencies, the following steps must be completed. Begin by clicking click on the magnifier glass located on the yellow box under the Track Location. Second, click on the “Routing Assignment List” (icon with the two heads). Manually uncheck the boxes next to the names of the other members of the study team to deselect them. Then, click on Save and continue twice. If you are not the person who needs to sign off, log out. The submission will be in the iRIS homepage of the person whose signoff is required.

If you are the person who needs to sign off you will see the “approve” radio button. Click on the approve radio button and enter your credentials to sign off. Finally, click on Save to save your sign off.

Q: How do I know if the IRB received my submission.

A: Your submissions forms are in the IRB inbox in iRIS when you see a green box under the Track Loction stating “Routing in Process.”

New iRIS users should use the iRIS User Manuals to ensure all the steps for routing submissions to the IRB have been completed.