ADD A NEW STUDY APPLICATION: https://iris.uth.tmc.edu/
- Log in using your UT assigned User ID and Password
- Click ADD A NEW STUDY on the top of the left hand navigation bar.
- Enter the requested information on each screen.
- Click SAVE AND CONTINUE on the top of the right hand side to save entries FOR EACH PANEL
- In the last panel, click AGREE or DISSAGREE on the STATEMENT OF THE INVESTIGATOR.
- Click SAVE AND CONTINUE
- Follow ROUTING PROCEDURES described below
COMPLETE THE SUBMISSION PACKET:
- Click THE GREEN TEXT BOX on the IRB SUBMISSION COMMENTS to add information for the IRB reviewers- (This is optional)
- Click THE GREEN BOX In the INFORMED CONSENT section
- Click ADD DOCUMENT
- Make the appropriate selection to add from a list or upload an existing document
- Click NEXT SCREEN
- Complete TITLE, VERSION DATE, VERSION NUMBER, LANGUAGE
- Click, UPLOAD YOUR CONSENT DOCUMENT
- Browse to locate the document for upload (Microsoft Word, RTF or PDF file only)
- Once the file is uploaded, click SAVE CONSENT
- In the next screen, click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- Click THE GREEN BOX in the REVIEW BOARD FORMS section to complete and attach HIPAA forms, MEMORIAL HERMANN HOSPITAL APPLICATION, etc.
- Click ADD NEW FORM for the appropriate form(s)
- Complete the form(s) and SAVE
- Click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- Click THE GREEN BOX on the STUDY DOCUMENTS to upload and attach the protocol, investigator’s brochure, copies of case report forms, etc.
- Click ADD NEW DOCUMENT or ADD MULTIPLE DOCUMENTS
- Complete TITLE, VERSION DATE, VERSION NUMBER, CATEGORY
- Click, UPLOAD
- Browse to locate the document for upload (Microsoft Word, RTF or PDF file only)
- Once the file is uploaded, click SAVE
- In the next screen, click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- Click the SAVE FORM on the top of the right hand side.
- IF complete, SIGNOFF AND SUBMIT
CONTINUING REVIEW:
- Log in using your UT assigned User ID and Password
- Click My Studies in the left hand navigation pane to view your list of studies
- Click on the study for which continuing review is due
- Within the study’s screen, click on CONTINUING REVIEW FORM
- In the continuing review screen, click ADD NEW FORM
- Complete each panel and click, SAVE & CONTINUE
- In the last panel, click SIGNOFF AND SUBMIT
- Follow ROUTING PROCEDURES
CHANGE REQUEST AND AMENDMENT:
- Log in using your UT assigned User ID and Password
- Click My Studies in the left hand navigation pane to view your list of studies
- Click on the study for which you would like to create a change request
- Within the study’s screen, click on CHANGE REQUESTS AND AMENDMENTS
- In the change request screen, click ADD NEW FORM
- Complete information in each screen, clicking, SAVE & CONTINUE to next section after each screen is complete.
- In the last panel, click SIGNOFF AND SUBMIT
- Follow ROUTING PROCEDURES
PERSONNEL CHANGE REQUEST:
- Log in using your UT assigned User ID and Password
- Click My Studies in the left hand navigation pane to view your list of studies
- Click on the study for which you would like to create a change request
- Within the study’s screen, click on PERSONNEL CHANGE REQUEST FORM
- In the next screen, click ADD NEW FORM
- Complete the screens, clicking SAVE & CONTINUE after completing each screen
- In the last panel, click SIGNOFF AND SUBMIT
- Follow ROUTING PROCEDURES
RETURN TO HOME PAGE:
- 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 arrow on the browser.
ROUTING PROCEDURES:
Once you have reached the end of a submission and clicked, SIGNOFF AND SUBMIT, you will be presented with a screen that says, “Does this submission require additional routing for approval?”
- Click Yes or NO
- If you select NO, click SAVE & CONTINUE
- APPROVE or DENY submission and enter UT ID and PASSWORD
- Click SAVE SIGNOFF
- If you select YES, click SAVE & CONTINUE
- Select KEY STUDY PERSONNEL by putting check marks next to persons to include in signoff
- Click SAVE & CONTINUE
- In the next screen, you may select ADDITIONAL PERSONNEL for routing and signoff by clicking ADD SIGNOFF
- Enter the person’s name and click FIND. The LDAP system will pull up appropriate names, CHECK THE SELECT BOX next to the correct name and click SELECT USER
- In the next screen, use the PULL DOWN MENU which appears under the name to SELECT A ROLE for this person.
- Click SAVE & CONTINUE
- You will have one more opportunity in this screen to add/remove KEY STUDY PERSONNEL and/or ADDITIONAL PERSONNEL – click appropriate option in the left hand column or select YES or NO to indicate whether you have completed your selections
- Click SAVE & CONTINUE
- APPROVE or DENY submission and enter UT ID and PASSWORD
- Click SAVE SIGNOFF
*Schematic representation of routing instructions
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link
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