All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. The IRB Application Guide will assist UT Austin faculty, staff and students who are planning to conduct research involving human subjects.
Once IRB approval or determination has been granted, researchers must follow IRB Policies and Procedures for follow-on submissions during the course of their research study to remain in compliance. Examples of follow-on submissions include modifications, continuing reviews (when applicable), and reportable new information reports.
Forms, templates and guidance documents are available for download via the UTRMS-IRB Library.
How to Submit an Initial IRB Application (New Study)
Initial/new study submissions are created in UTRMS-IRB. The following documents should be uploaded with the online application. The Getting Started and Creating a New Study Submission (PDF) document provides step by step instructions on how to create and attach submission documents.
IRB Proposal Template
Download templates from the UTRMS-IRB Library Templates page. One of the following must accompany an online submission.
HRP-UT901 – Template IRB Proposal Standard Submission
Use of greater than minimal risk studies and minimal risk studies that fit into one or more expedited categories (see Section 5.3 of the IRB Policies and Procedures Manual for details regarding expedited research). Do NOT submit this form if the study will qualify for exempt review (see Section 5.4 of the IRB Policies and Procedures Manual for details regarding exempt research).
HRP-UT902 – Template IRB Proposal Exempt Submission
Use for studies that will meet one or more categories for exempt review (see Section 5.4 of the IRB Policies and Procedures Manual for details regarding exempt research.
HRP-UT903 – Template IRB Proposal Secondary Use Submission
Use for studies that are ONLY utilizing secondary data or specimens and that meet the criteria for human subjects research. If conducting chart reviews only (retrospective or prospective) use this form; do not use the exempt form or standard submission form.
HRP-UT912 – Template IRB Proposal Humanitarian Use Device Submission
Use this form ONLY for HUD submissions.
Supplemental Forms
Download applicable form from the UTRMS-IRB Library Templates page.
If the research involves any of the following, submit the appropriate Supplemental form with the UTRMS-IRB application: biospecimens (HRP-UT904), investigational device (HRP-UT905), investigational drug/biologic (HRP-UT906), PHI (HRP-UT907), international research (HRP-UT908), prisoners (HRP-UT909), registry/repository (HRP-UT910), Department of Defense (DoD) sponsored/funded (HRP-UT911).
Consent, Parent Permission and Assent Forms
The UT IRB has consent, parental permission and assent form templates available for download in UTRMS-IRB Library Templates. English and Spanish versions of the templates are currently available. It is recommended that researchers use the available templates for a more efficient review.
Other Documents
- Letters of Support/Site Letters
- Other IRB Approvals
- HIPAA authorizations (if separate from consent forms) – HIPAA Authorization templates are available via UTRMS-IRB Library, Templates.
- Recruitment Materials
- Surveys/questionnaires/data collection tools/interview scripts/intervention manual
- Other documents as appropriate to facilitate review of the research
Applying for Modifications
Changes in study procedure or personnel for studies that were reviewed and approved as expedited or full board must be submitted and approved by the IRB prior to implementation by submitting a modification application in UTRMS-IRB. By starting a modification application, the currently approved IRB application is opened for editing. This allows researchers to alter, delete or add to the current application and/or supplemental documents.
Exceptions to this process can only be made when there are concerns for subject safety. If there are subject safety concerns, email irb@austin.utexas.edu as soon as possible. as soon as possible. See Section 8: Modification/Amendment of Human Subjects Research Activities in UT IRB Policies and Procedures for additional information.
Studies determined to be exempt at time of initial review require a modification submitted via UTRMS-IRB if the change(s) to the research involve a change in PI, increase risk to participants or otherwise affect the exempt category or the criteria for exempt determination. Researchers are encouraged to contact IRB staff if unsure whether proposed changes to exempt research would require a modification application.
To submit a modification application, log in to UTRMS-IRB, and navigate to the study to modify. Under Next Steps, click “Create Modification/CR/Closure” and select “Modification/Update.”
- If ONLY changing research personnel, choose “Study team member information” as the modification scope. For all other changes, choose “Other parts of the study”.
Complete the Modification application by summarizing the modifications such that IRB reviewers can adequately understand proposed changes. Use the “Update” button to upload revised versions of currently approved study documents. To add brand new study documents, click the “+Add” button to upload.
Continuing Review
Annual continuing reviews are required for greater than minimal risk research, research regulated by the FDA and research sponsored/funded by the Department of Justice. Most minimal risk research studies approved via the expedited review pathway do not require annual continuing review. The IRB may require continuing review for special circumstances, to be determined on a study-by-study basis and documented as part of the review.
Researchers can identify if their study requires a continuing review by confirming if there is an approval end date present on the study workspace. UTRMS-IRB will also send periodic reminders to notify researchers if their study requires a continuing review.
To submit a continuing review application, log into UTRMS-IRB and navigate to the study to modify. Under Next Steps, click “Create Modification/CR/Closure” and select “Continuing Review/Study Closure”. Complete the continuing review application.
To submit a modification along with a continuing review, choose “Modification/Continuing Review” and complete the application.
Reportable New Information (RNI)
To ensure the protection of research participants, the IRB requires investigators to report certain information during the course of the research, either promptly or at the time of continuing review. This may include events where participants experience unanticipated problems or when there is potential noncompliance.
For the IRB policy regarding reporting unanticipated problems or instances of potential noncompliance, see Section 9: Reporting Unanticipated Problems and Section 22: Protocol Deviations and Noncompliance of the IRB Policies and Procedures Manual.
How to Submit RNI and Monitoring Reports
Written reports from study monitors, including Data Safety and Monitoring Board reports can be uploaded for IRB review via the RNI process.
To submit an RNI, log into UTRMS-IRB and click on “Report New Information”. Complete the RNI SmartForm. When describing the information, include the following as applicable:
- What happened, when and where
- What factors and contributed (role, not name) to why it happened
- What was done to address the issue before submitting the RNI to the IRB
- What is the plan going forward for preventing this from happening again
- Answer questions regarding risk/safety, study revision and consent revision.
- If “yes” is answered to any of these questions, include additional details as applicable in the description section.
- If the event is related to a current study (or studies), choose the related study in question 8.
- Attach any files containing supporting information related to the event, the root cause analysis,or the corrective and preventative action plan.
- If the event is for a study where UT Austin deferred IRB review to an external IRB, upload the reviewing IRB’s determination letter. If not available at the time of submission, proceed with submission and upload once available.
- Click Continue when you have completed the application and Submit to submit the application for review.
RNI Review Process
Pre-Review
The RNI will undergo initial pre-review by IRB staff to ensure that the submission is complete and in keeping with the IRB requirements. The RNI submitter may be asked to provide additional information. Once the submission is determined to be complete and if the RNI requires further IRB review, it will be routed for expedited or full board review as appropriate.
If during review, the event reported clearly does not meet the criteria for an unanticipated problem or potential noncompliance, the IRB staff may acknowledge the report.
IRB Review
Expedited Review
The submission is sent to an IRB member for review. The submission will receive one of the following determinations:
- Non-compliance that is neither serious nor continuing
- None of the above (not noncompliance, not an unanticipated problem, etc.)
An acknowledgement letter that may or may not request additional actions will be issued via UTRMS-IRB. If additional action is specified, a modification or additional RNI must be submitted, as applicable.
Full Board Review
The submission will be assigned to a Board meeting for review. The submission will be presented at a convened meeting for discussion. The submission will receive at least one of the following determinations by the IRB:
- Unanticipated problem involving risks to subjects or others
- Non-compliance that is neither serious nor continuing
- Serious non-compliance
- Continuing non-compliance
- Suspension or termination of IRB approval
- None of the above
If the IRB determines the reported event constituted an unanticipated problem or serious and/or continuing noncompliance and the study is funded by HHS or subject to FDA regulations, these agencies will be notified by the IRB of this finding.
An acknowledgement letter that may or may not request additional actions will be issued via UTRMS-IRB. If additional action is specified, a modification or an additional RNI must be submitted, as applicable.
Study Closure
A closure report must be submitted to the IRB in UTRMS-IRB for each human research study, regardless of whether a study is subject to continuing review requirement. Investigators are required to submit final study closure reports when all of the following apply:
- Study is permanently closed to enrollment,
- Participants have completed all research activities, and
- Collection and analysis of identifiable information is complete.
To submit a closure application, log into UTRMS-IRB and navigate to the relevant study. Under Next Steps, click “Create Modification/CR/Closure” and select “Continuing Review/Study Closure”. Complete the Continuing Review/Closure application.
Email Notices
The Office of Research Support and Compliance and Compliance notifies PIs 90, 60 and 30 days prior to the study expiration date. These emails are automated and only warnings about the upcoming expiration date. All emails are sent to the email address on file in Workday.