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Human Subjects Committee

The IRB-Human Subjects: What it is and how it works

IRB-Human Subjects is an acronym for the Institutional Review Board for the protection of human research subjects.

All universities, hospitals and other institutions that conduct research using humans as research subjects are required by law to establish a committee responsible for reviewing proposed research involving human subjects to ensure that the rights and welfare of the subjects are protected. To comply with this law, UTB has established the IRB.

The UTB IRB policy requires that all research involving human subjects, whether funded by an external organization or not, must comply with regulations for human subject research established by the U.S. Department of Health and Human Services and described in the Code of Federal Regulations 45 CFR 46, the Belmont Report and the American Psychological Association "Ethical Principles in the Conduct for Research with Human Subjects."

Criteria for IRB - Human Subjects Review

Research projects submitted to the IRB for approval are screened by the IRB Chair and placed in one of the following three review categories:
Only the IRB can determine the classification of protocols

Exempt from Review:

The IRB certifies whether protocols meet the qualifications for exempt status through a formal review. This certification serves as an assurance that the project qualifies for exempt status according to federal regulations, and protects the rights and welfare of human subjects.

Complete the "Protocol Review Form (PDF) to submit a project for exempt status review. Exempt projects must meet one or more of the following criteria:

  • All research activities involve minimal or no risk for participants.
  • Research is conducted in an educational setting that focuses on instructional strategy or effectiveness of educational techniques or curricula.
  • Research that utilizes educational tests (cognitive, diagnostic, aptitude and achievement) provided that subjects remain anonymous.
  • Surveys may be exempt unless any of the following conditions prevail:
  • Participants can be identified (directly or indirectly).
  • The responses, if they became public, could place the person at risk.
  • Research involves "sensitive aspects" of the participant's behavior or personal records (illegal conduct, drug/alcohol use, sexual behavior).
  • Research involves children as subjects.

Expedited Review:

Projects that qualify for expedited review are first reviewed by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. If the vote for approval is not unanimous, the project will go to the Full Board for review. Research activities must involve no more than minimal risk to human subjects and meet one or more of the Qualifications for Expedited Review.

Complete the "Protocol Review Form" (PDF)

  • Research activities involve no more than minimal risk to human subjects.

Full Board Review

Complete the "Protocol Review Form" (PDF)

  • All projects involving human subjects that do not qualify for exempt or expedited review must be reviewed by the full IRB at an official committee meeting.

Continuing Review / Project Completion

Projects will be required to cease work if IRB approval for continuation is not secured. Required for all approved protocols as follows:

  • Continuing review at intervals appropriate to the degree of risk (designated by IRB), but not less than yearly, is required by federal regulations.
  • Review by the first anniversary of the original approval date is required for projects that continue and are not completed.
  • Minimum annual review.
  • Project Completion – All protocols.

More information

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