An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subjects research be conducted in accordance with all federal, institutional, and ethical guidelines. The goal of the IRB is to provide all stake holders with information, guidance, forms, and related materials needed to secure IRB approval for human subjects research. 

The IRB reviews research projects which involve human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they are not coerced into participation in research, rather they are recruited to participate through informed consent.

IRB is comprised of peer faculty from a wide range of scientific and academic disciplines, and representation from local community outside of the academia. The IRB gives rapid but individualized attention to the research submitted by internal and external investigators, including community members.

IS IT HUMAN SUBJECTS RESEARCH?

Is it Research?

Research is defined by DHHS as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities”.

*Research is defined differently by the FDA and has additional requirements.

Is it a Human Subject?

A Human Subject is defined by DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through  intervention or  interaction with the individual, or

2. Identifiable  private information

*A Human Subject is defined differently by the FDA and has additional requirements.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). It must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Do I need to submit?

All individuals engaged in human subjects research that is supported by A&M-San Antonio; conducted by or under the direction of any faculty, staff, student, or agent of A&M-San Antonio in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of A&M-San Antonio using any property or facility of A&M-San Antonio; or involved in identifying and contacting human research participants or prospective participants, must submit an application to the IRB prior to commencement of any research activities.

How do I submit?

The required IRB Protocol Application and required supporting documents can be found here. Please submit all documents as one pdf packet and email the pdf as an attachment to irb@tamusa.edu. 

What if I am not sure?

If you have questions about whether research is classified as human subjects research, contact the Research Compliance Administrator, Blanca Cuellar at irb@tamusa.edu. 

The Office of Research Compliance is available for consultations with individuals and groups.  Please bring your specific questions and concerns to discuss your research. 

Disclosure

To report any concern, individuals can call 210-784-1223 or make anonymous reports to the TAMU System via the Risk, Fraud, and Misconduct Hotline or by calling the Texas State Auditor’s Office at 1-800-892-8348.