iRIS Navigation
Open a Specific Research Study
Review Documents Associated With Submission
Find Current Reviewer Comments From Your Tasklist
Review a Submission Assigned to You
Log into iRIS at https://iris.uth.tmc.edu/ using your UTHealth user ID and password.
Open a Specific Research Study
- Click the blue IRB ASSISTANT button at the bottom of the left hand navigation bar.
- Click FIND A STUDY in the left hand navigation bar.
- Type in the HSC number in the field IRB NUMBER
- Click FIND or ENTER
- Click open icon next to the study.
- You are at STUDY MANAGEMENT view. From here you can access the entire IRB file on the research study.
- Click SUBMISSION HISTORY - the second item on the list under the Miscellaneous Tab.
- Click the tab COMPLETED SUBMISSIONS.
- Find the submission of interest (Initial Submission, Change Request, Continuing Review, and Unanticipated Problem etc.)
- To review outcome letter for a specific submission, click the icon under VIEW OUTCOME LETTERS.
- To open the submission, click the text of the submission under REQUEST TYPE.
Review Documents Associated With Submission
- When you open a submission there is a navigation toolbar on the left with several links.
- Click SUBMISSION COMPONENTS link, this will the IRB form that was submitted below includes all the documents attached that are associated with this specific submission including application form, protocol, consent document and any other documents submitted.
- Once you navigate away from the home page, to return HOME
- Click the HOME button in the upper right, clicking home on the navigation link, or
- Click BACK button on the upper right part of the screen until you reach the home page. Do not click back on the browser.
Find Current Reviewer Comments From Your Tasklist
- Click Open Task icon for the study you are interested in. It should open up the reviewer comments area for that submission.
- You can start from two different screens:
- If you are starting from the meeting agenda - click CLICK TO OPEN icon in the second column of the table for the item of interest. Click REVIEW CHECKLIST AND COMMENTS on the left side of the screen to find the current comments.
- If you are starting from the main iRIS page – follow instructions to find a study.
- Click SUBMISSION HISTORY, the second item on the list under the MISCELLANEOUS button in blue on top next to Protocol Items.
- Click the second tab COMPLETED SUBMISSIONS.
- Find the submission of interest. TIP: A single submission might have been through several rounds. For example, an initial review might have been sent back for corrections once or twice, and then scheduled for review at the meeting. The submission might be sent back again with stipulations. Each of these submissions will have associated letters and reviewer comments.
- To review outcome letter for a specific submission, click the icon under VIEW OUTCOME LETTERS.
- To open the submission, click the text of the submission under REQUEST TYPE.
- The documents that were included in this submission can be found in the second link on the left called SUBMISSION COMPONENTS.
- The comments from reviewers can be found in the seventh link on the left under REVIEWER COMMENTS
- The stipulations sent to the PI may be found in the OUTCOME LETTER or if you wish to see the stipulation and the response, you can look under the link on the left called STIPULATIONS
Review a Submission Assigned to You
- When you log in to iRIS, you will be taken to the home screen which will list all the tasks assigned to you.
- Each task is listed with the following information:
- Study Title
- PI name
- HSC number
- Review Type:
- If it says Expedited Review, it means you are the only reviewer assigned to this task and that unless you think it would benefit from discussion at the next meeting, the item can be approved or approved with stipulations as soon as you have completed the review.
- If it says Board Review – the date listed will be the meeting date. We strongly encourage you to complete your review and enter your comments as soon as possible so that we can request the PI for answers to any questions you may have before the meeting.
- Submission Type: this tells you whether the submission is an initial review or a change request, or continuing review or others.
- Click OPEN TASK icon (looks like a paper on a clipboard).
- You will be taken to the screen where you can input your comments.
- On the left side of the screen, there are several links:
- GENERAL INFORMATION – here you will find a summary of the protocol written by the IRB staff. This summary will list any additional regulations you may have to consider while reviewing the protocol.
- SUBMISSION COMPONENTS – this link will take you to all the documents submitted by the PI in the initial submission packet. You will commonly see two links at the top:
- Review Response Submission Form – this will take you to the packet revised by the PI in response to pre-review changes requested by the IRB office.
- Initial Review Submission Form – this will take you to the packet initially created by the PI.
- SUBMISSION ATTACHMENTS: Under this, you will find a table of the various documents submitted by the PI in the initial submission packet. Some of the common documents include the Application, Protocol, Consent Documents, Recruitment materials and Case Report Forms.
- Once you have reviewed the documents, click the link REVIEWER CHECKLIST AND COMMENTS on the left side of the screen.
- Click Add Member Comments and type your comments here.
- Once you have entered the comments, click COMPLETED.
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
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Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
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