GET HELP: IRIS is the electronic system used for IRB submissions. Investigators, study personnel residents and students are strongly encouraged to attend an IRIS training session before using IRIS for the first time. Please review the training schedule and contact Mayra Cagganello (860-679-8802) to register for a session.
If additional guidance is needed regarding the IRB submission process (e.g., initial submission, continuing review, request for modification, problem report form), Mayra can also provided education related to preparing an IRB submission. The IRB Regulatory Specialists (Donna Horne x4851, Patricia Gneiting x4849, Pamela Colwell x1019) are also available to provide assistance if Mayra is not available.
IRIS is used by research personnel to submit material to the IRB for review, and by IRB staff and members to review that material, impose contingencies for approval, record approval outcomes, and communicate those outcomes back to the research team. The URL is https://imedris.uchc.edu/. UConn Health employees log in with their UConn Health user ID and Password. Individuals external to UConn Health, who are not already part of an approved study, should go to the URL and click the Request Account option, being sure to describe why the account is needed.
IRIS Training sessions are offered to the research community. Study Coordinators and Principal investigators are encouraged to review the IRIS training sessions schedules. To reserve a seat e-mail Mayra Cagganello (email@example.com) at least five (5) business days prior to the training day.
Training Guides: Per Vendor requirements, Training Guides may not be posted to the web. IRIS User Manuals can be found in the Help section of IRIS. Please contact Mayra Cagganello if you have any questions about this User Manuals (firstname.lastname@example.org /860-679-8802)
IRIS Frequently Asked Questions
Do I need to request an account to access IRIS?
If you are a UConn Health employee/student you do not need to request an account to access IRIS. You should use your Network ID and Password to log in to IRIS. External users for a new study should go to https://imedris.uchc.edu to request an account. In the request form they should explain the reason an account is needed and note the name of the UConn Health person with whom they will be working (e.g. the study title, UConn Health colleague, CICATS research etc.)
How do I access IRIS from outside of UConn Health?
The web location IRIS is https://imedris.uchc.edu. As long as you have a UConn Health ID and password, or have had an IRIS account ID and password issued to you, you will be able to access the system at this URL.
Do I need to submit the Principal Investigator C.V or Biosketch when completing and Application for Initial Submission in IRIS?
Attachment of these documents is necessary if the PI’CV is not available in IRIS PI’s profile and the qualifications of the PI are not described within the application.
Who Needs to Sign-off on the Initial Submission of an Initial Application in IRIS?
The Principal Investigator listed in section 3.1 and all personnel listed in section 3.2 (e.g. co-investigator, study coordinator or person obtaining consent) are required to electronically sign off on the initial submission of the Application.
If the Initial Submission has been returned for corrections from the screening phase only the person responding to the corrections needs to sign off. If the Initial Submission has been returned for responses from the official IRB review process, only the PI would need to sign-off. If other members of the study team are defaulted to being selected for sign-off you can uncheck the box to deselect them when responding to changes required by the IRB. Multiple rounds of screening may be conducted for Initial Submissions before the submission is forwarded to the IRB Chair/IRB Panel for final review.
Who needs to sign off on other Submissions in IRIS?
Initial Submission of Application: Everyone listed in section 3.1, 3.2 –A and 3.2 –B of the key study personnel in the application (e.g. Principal Investigator, Back-up Principal Investigator, Co-Investigators, Registry /Repositories Data Manager, Study Coordinator, and Consenters).
For Continuations, Modifications, Problem Reports Forms and Closure Forms only the Principal Investigator signature is required on the submission. If necessary, manually uncheck the names of the personnel not required for routing and signoff of continuations, modifications, study closures and problem report forms. If the names are not unchecked the system will automatically send notifications to those people requesting their sign off on the submission. When new personnel are being added to the study, they will be asked to sign off by the IRB as a contingency for approval.
For Submission Correction Forms: Submission Corrections are generated from the IRB screening process which occurs prior to official review by an IRB member. Only one person needs to sign this form; and it will most often be the person responding to the IRB Contingencies (e.g. a study coordinator).
For Submission Response Forms: A submission response task is triggered after the IRB has conducted an official review (either by an IRB Chair or by a Full Panel). The Principal Investigator is the only person required to sign off on a completed review response form.
Who Do I need to list as a Study Contact In the IRIS Application?
The study contacts automatically receive all system generated correspondence (e.g. reminders to request continuations, notifications of lapses in approval, IRB approval letters). The Principal Investigator and Study Coordinator(s) should always be listed in this section; as well as any persons who may be designated to complete IRB submission forms for the study. If the person who needs to receive correspondence about the study has not been listed in this section, that person will not receive study correspondence. For studies supported by the clinical research center, investigators should add Kristen Tremblay. If the study is strictly a Service Center study, (i.e. the PI pays for support) investigators should add Thomas Kiely as a contact. Study contacts must be listed by individual names.
What should I do if I have problems attaching and /or opening documents in IRIS?
If you are unable to open documents and/or upload documents in to IRIS you should make sure that your computer has the minimum necessary requirements systems set up: (a) Internet Explorer 9.0 browser is preferred and (b) Popup blocker is off.
How do I know if the IRB has received a submission I completed in IRIS?
To confirm that your submission has been routed by the system to the IRB you can go to your Study Assistant Tab, and click on “My Studies.” Then open the study you have completed and submitted. Once you are in the Submission tab, click on the Submission History and then on the Track Location. If the submission has arrived to the IRB queue, you will see the following statement: “UConn Health received the submission.”
If I am Adding a Modification Form in IRIS and the Modification includes adding a new person to the study team, does this person need to sign off the Modification Form?
IRIS doesn’t allow for routing of the Modification Form to the person/s being added as personnel in a study. Therefore, the person(s) being added can’t sign off the Modification Form prior to it being submitted to the IRB.Once the IRB receives the Modification Form the IRB Coordinator will route the form to the person(s) being added.
Should all Consenter’s names be listed underSection 3.2 –B of an Initial Application in IRIS even if there are 10 consenters?
Yes, every person who will be obtaining consent must be listed under section 3.2 –B of an Initial Application in IRIS
What Documents should I submit when I am submitting a Continuation and/or a Modification for an Existing Study in IRIS?
The documents that are required for submission at continuation can be found on the submission checklist available on the HSPO website. The documents required for a modification are submission specific so a checklist is not available. In general you need to submit any previously approved form to which a change is being requested, any new form not previously approved for use with the study (e.g. new recruitment material), or new information that pertains to the study (e.g. outcomes of meetings of the data safety monitoring board).
What types of documents can I submit in IRIS?
You can attach a variety of documents types, however IRIS can only stamp/approve documents that are submitted in Microsoft Words or PDF formats.Furthermore, different documents types sometimes cause problems on the IRB review side, such as corrupting system generated pdf files. Study personnel are strongly encouraged to convert other document types (e.g., excel, jpg, gif, ppt) to a PDF file prior to attaching them to a submission.
Can I work in IRIS using Mozilla Firefox or Chrome?
IRIS was tested with Internet Explorer 8 which is the current recommended version. The vendor has recently indicated that IRIS is compatible with IE 9 for 32 bit machines. (Contact I.T. if you need help determining if you have a 32 bit or 64 bit machine). Many investigators have encountered multiple problems in IRIS when using either Mozilla Firefox, Chrome or a higher version of Internet Explore such as 10.