Expert review of research protocols is carried out through the work of UT Austin’s two IRBs to ensure that research is well designed and likely to yield generalizable knowledge, and that risks are commensurate with benefit and accurately disclosed to research participants. The IRB has the authority to approve, require modifications, disapprove, suspend, terminate and observe the consenting process for research that falls within its scope of review, as specified by federal regulations and institutional policy. UT Austin has two IRBs: a Social Behavioral and Educational Research IRB (SBER_IRB) and a Health Sciences IRB (HSIRB).
The HRPP and the UT IRBs have been accredited by the Association for the Accreditation of Human Research Participants (AAHRPP) since 2006.
Activities Requiring IRB Review
UT’s IRB’s provide ethical oversight to all activities that meet the regulatory definitions of research involving human subjects conducted by UT faculty, staff or students.
Research requires IRB review under Department of Health and Human Services (DHHS) regulations if the project is a systematic investigation designed to develop or contribute to generalizable knowledge AND involves living individuals about whom an investigator:
- Obtains information or biospecimens through intervention or interactions with the individuals, and uses, studies or analyzes the information or biospecimens
- Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens
Additionally, research requires IRB review under FDA regulations if the project meets the definition of a clinical investigation — any experiment that involves one or more human subjects and an FDA-regulated test article (drug, device, biologic, human food additive, electronic product) other than in the course of standard medical practice — AND involves a human subject defined as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or a patient.
If a research project meets either two scenarios above, IRB review and determination is required prior to beginning any research activities involving human subjects.
If an activity does not meet the regulatory definition of “research,” no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects, the research does not require IRB review. Failure to meet either definition means that the activity is not human subjects research.
For help determining if research meets these regulatory definitions before submitting to the IRB, contact the IRB staff at irb@austin.utexas.edu or online chat.
Determining When to Submit Activities to the IRB
Examples of Activities that May or May Not be Human Subjects Research (PDF)
NIH Decision Tool: Am I Doing Human Subjects Research?
HRP-310 – Worksheet: Human Research Determination (DOC)
PI Eligibility
The principal investigator (PI) of a human research study is the individual with ultimate responsibility for the conduct of the activities described in the IRB submission and for protecting the rights and welfare of human participants involved in the research. The PI must be available to devote adequate time and attention to the study to ensure its responsible conduct.
Faculty Sponsors
A faculty sponsor, who is eligible to serve as a PI, is required for all students conducting human subjects research and should oversee the conduct of student conducted research. Students and their faculty sponsors are responsible for human subjects protections. The faculty sponsor is typically the student’s dissertation or thesis chair; however, this is not always the case. The sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects.
In the UTRMS-IRB system, the faculty sponsor will be listed as the PI and the student investigator should be designated as the PI Proxy. The PI Proxy will be able to submit actions in the UTRMS-IRB system.
Review Process
In the UT Research Management Suite – IRB Module, researchers can see at a glance where their submission is within the review process. At the top of the study action workspace is the workflow.
The RMS system uses “states” to classify where a submission is in the process. The following table defines the possible study states for a new study submission during the course of its review.
Study States
Pre-Submission
The application is under preparation by the PI/submission preparer. The study will remain in this state until the PI/PI Proxy clicks Submit.
Pre-Review
The submission is in the queue / is being reviewed by the assigned IRB Analyst.
Clarifications Requested Pre-Review
The IRB Analyst has requested changes or clarification. The PI, PI Proxy and Primary Contact will receive an email notification advising them of the request. Details regarding the request can be found in the study workspace.
IRB Review
The submission is currently being reviewed by an IRB member.
Clarifications Requested IRB Review
The IRB member has requested changes or clarifications regarding the submission under review.
Post Review
The IRB letter advising the PI of the IRB member or IRB committee’s decision is being prepared.
Modifications Required
The IRB has requested additional modifications to secure final approval. The PI, PI Proxy and Primary contact will receive an email notification advising them of this request.
Review Complete
The PI will receive the final approval/determination letter and IRB review is complete.
Departmental Review
Some academic areas have a departmental review process for research submitted to the IRB. Researchers must follow all departmental requirements for review and approval, if applicable. For questions about the rules and procedures for departmental review or the applicability of this information to a submission, please contact the appropriate department.
IRB Review Types
Depending on the type of research conducted, it may be exempt, expedited or require full board review. The type of review is determined by risk level and categories as defined by federal regulations. Minimal risk is defined by federal regulations as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(j)].
Refer to Single IRB (sIRB) Reliance for information about research studies implementing a single IRB review for multi-site/collaborative studies.
Exempt Review
Federal regulations identify several different categories of minimal risk research as being exempt from the regulations. This does not mean that they are exempt from IRB review, only that some of the federal requirements that apply to non-exempt studies are not applicable to studies deemed exempt. For example, exempt studies are not required to obtain written informed consent and are not required to submit modifications prior to implementation (unless they may affect the exempt status of the study).
Exempt reviews are performed administratively by the IRB Minimal Risk Research Team. For detailed information on the exempt categories and exempt submissions, refer to the IRB Policies and Procedures Section 5.4 Exempt Research. FDA regulated studies are not eligible for exemption under these categories.
Expedited Review
Unlike exempt review, expedited review falls under the full scope of the regulations and is reviewed by a designated IRB member reviewer. Expedited studies must fall into one of the Expedited Review Categories.
All expedited studies must adhere to the requirements for informed consent or its waiver or alteration. Expedited studies may or may not be required to undergo continuing review. All modifications must be approved by the IRB prior to implementation, unless they are necessary for the immediate safety of participants.
Full Board Review
Studies that are not eligible for expedited review (do not meet the definition of minimal risk and/or do not fit into an expedited category) must be reviewed by the convened IRB.
All full board studies must adhere to the requirements for informed consent or its waiver or alteration. Full board studies must undergo continuing review at least annually. All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of participants.
Please email irb@austin.utexas.edu with questions or to set up a consultation. Include information about the proposed research study or UT IRB Study Number (if available) along with questions to facilitate an efficient response.
Electronic Submission
All new human subjects research applications must be submitted electronically via the UT Research Management Suite – IRB Module (UTRMS-IRB). If a study was originally approved in the legacy system, historical study documents and IRB determinations can be accessed in IRBaccess.
Submitting to the IRB
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.
- See the step-by-step instructions on submitting new studies via UTRMS.
- Forms and templates are available for download via the UTRMS-IRB Library, “Templates” tab.
- Guidance documents help with questions during the submission process.