IRB FAQ's - Frequently Asked Questions

What is the Institutional Review Board (IRB)?

The UTSA IRB is the standing committee that reviews and approves human subject research for the purpose of protecting the rights and welfare of those subjects. The IRB operates under the oversight of the Office of Human Research Protections (OHRP) under the Department of Health and Human Services (DHHS).

Who should submit research to the IRB?

• UTSA faculty, students, or staff conducting human subject research as a part of their position at UTSA
• Investigators who wish to recruit UTSA students, faculty, or staff using non-publicly available information or access to those persons
• Investigators conducting human subjects research using UTSA facilities (when UTSA is engaged in research - consult the IRB Office for further information regarding engagement in research)

What is meant by "research"?

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (Code of Federal Regulations: Title 45, Part 46.102).

What is meant by "human subject"?

Human Subject refers to a living individual about whom an investigator conducting research obtains
(1) data through intervention or interactions with the individual, or (2) identifiable private information.

• An example of public (non-private) information is the telephone book.
• An example of private information would be a student's UTSA transcript.

How do I apply for IRB approval?

Application forms and instructions are available on this website under Forms and Instructions. Submit your application, research protocol and any additional documents (consent forms, etc.) to the IRB office in MS 4.01.84. Deadlines for submission are posted on the website.

What Information should I include in the Informed Consent Form?

Federal regulations include required "elements of consent" to be provided to prospective subjects. The website contains a template with standard wording to guide writing an informed consent document. The template contains the required elements. (A list of required elements and UTSA formatting requirements is available on this website under Forms and Instructions.

When can I apply to the IRB for approval?

Some research studies must be reviewed by the IRB at a convened meeting. The convened meeting is held once each month, and the deadline for the IRB's receiving the application is usually two weeks prior to the meeting (see the website for important dates and deadlines.) Other studies may qualify for either Expedited or Exempt Review by the IRB Chair or the Chair's designee. These types of research involve minimal risk and fall into one or more defined category(ies). There are no deadlines for submission, and these studies are reviewed in order of submission. (See Categories of Exempt and Expedited research on this IRB website under Ethics/Regulations/Guidelines.)

Is there a time period for IRB approval of a research study?

The IRB will inform you of the period of approval in the Approval letter; the period of approval is limited to no longer than one year from the date of approval. Regulations require that the study undergo continuing review by the IRB at least annually. A Progress Report for is available on the website and should be submitted at least one month prior to expiration. (Regulations do not allow a grace period past expiration.)

How do I obtain approval for a change to my research?

Submit an Amendment request to the IRB for approval prior to implementation of any change to the research. The Amendment Form is available on this website under Forms and Instructions.