Human Subjects Research (IRB)

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

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 who wish access to those individuals. 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)

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).

An exercise conducted for educational purposes only and not for the purposes of developing generalizable knowledge may not constitute research. Moreover, using a survey to collect data specifically for the purpose of internal program evaluation and quality improvement may not constitute research.

Human Subject refers to a living individual participating in an investigation where the following will be collected:

• data through intervention or interaction with the individual, or
• identifiable information, specimens, cells, tissue, etc.
  
  • An example of public (non-private) information is the telephone book.
  • An example of private information would be a student’s UTSA transcript.

All new submissions must be submitted using Cayuse IRB. All previous submissions will continue to be managed using the old forms outside of the electronic system.

Studies, or research, that involves more than minimal risk must be reviewed by the IRB at a convened meeting. A convened meeting is held once each month and applications should be submitted at least 6 weeks prior to an IRB meeting. View Convened IRB deadlines.

All other human subjects research (e.g., exempt or expedited) that involve minimal risk procedures may qualify for review by the IRB Chair or the Chair’s designee. There are no deadlines for submission for these studies. They are reviewed in order of in-processing date.

Minimal risk typically refers to procedures or activities that an average person would expect to occur during their daily life.

The IRB will inform you of the approval period in your official letter. Regulations require that some studies require annual review. Researchers will receive a check-in e-mail from the IRB Office close to the approval anniversary date. If you plan to continue the research, you must respond to the e-mail. Otherwise, your study will be closed and you may not continue conducting the research.

Submit a request for a modification to the protocol (Modification Application) for IRB approval prior to implementation of any change to the research.

First, determine who will be the lead PI. If the study is funded, the lead PI will be the primary investigator listed on the grant. If the study is not funded, the lead PI will be the investigator conducting the bulk of the research on his/her campus.

If the lead PI is affiliated with UTSA, the PI will complete the submission in Cayuse as normal. There is a section in the protocol asking about collaborations with other institutions. Complete that section, making sure to include the contact information for the IRB Offices at the other institutions. Our office will contact the other IRB Offices to determine whether they are willing to enter a reliance agreement allowing us to serve as the IRB of record.

If the lead PI is not affiliated with UTSA, the lead PI will submit the study to the IRB at their institution. That IRB should contact us and we will determine whether we can enter a reliance agreement ceding review to them.

Please note, federally funded Expedited or Full Board studies must be reviewed by a single IRB with reliance agreements in place for the rest of the participating institutions. Exempt studies are not subject to this requirement and reliance agreements are completed on a case-by-case basis.