IRB Determination Request

If a project involves 'human subjects' and is 'research' as defined in the regulations, then it will require IRB review and an IRB application must be submitted through Kuali Protocols. It can be very difficult to determine what constitutes human subjects research. The federal definitions are broad and are commonly misinterpreted. As a result, many faculty and student researchers submit a research protocol for review that, per regulatory definition, may not require IRB review because it does not meet the definition of human subject research.

‘Research’ is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it includes both research and human subjects.

Research is:

Systematic Investigation

Typically predetermined method for studying a specific topic, answering question(s), testing a specific hypothesis, or developing theory. A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective and a set of procedures intended to reach the objective, i.e., to acquire knowledge, develop a theory, or to answer a question.

• INCLUDES: observational studies, interview or survey studies, group comparison studies, test development and interventional research
• NOT SYSTEMATIC INVESTIGATIONS: oral history, journalism, phenomenological activities
• IT DEPENDS: Program Evaluation – need to assess design and intent

Generalizable Knowledge

• New information intended to be shared, published, presented, and is intended to have an impact (theoretical or practical) on others within one’s discipline.
• The intent or purpose is to dissemination of findings (via publication or presentation) outside of Texas State University.
• Dissemination with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge.

A Human Subject is:

A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information.

• Intervention is a manipulation of research participants’ environment for modifying one or more health-related or behavioral processes or endpoints.
• Interaction includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey.
• 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

IF YOU THINK THAT YOUR STUDY DOES NOT CONSTITUTE RESEARCH INVOLVING HUMAN SUBJECTS, RESEARCH INTEGRITY AND COMPLIANCE WILL MAKE A FINAL DETERMINATION OF WHETHER OR NOT A STUDY REQUIRES REVIEW. IF YOUR STUDY DOES NOT REQUIRE IRB REVIEW, THEN YOU WILL RECEIVE AN OFFICIAL WRITTEN STATEMENT EXPLAINING THE DECISION. THIS LETTER MAY BE PROVIDED TO THE GRADUATE SCHOOL OR ACADEMIC PUBLICATIONS UPON REQUEST.