What Needs IRB Approval
Much of the research involving human subjects conducted by University of San Francisco students, faculty and staff is either exempt or eligible for expedited review.
Some research falls outside the scope of the IRB regulations. The federal regulations are clear about what categories of activities fall within their purview. However, they are not always entirely transparent and unambiguous. The following definitions are derived from the Code of Federal Regulations 45 CFR 46.
What is Research?
- Any activity that is designed to test a hypothesis or otherwise produce generalizable knowledge. Not all data collection is intended to produce generalizable knowledge. Activities that tend to fall outside of the consideration of research are Quality Assurance or Quality Improvement studies. These activities are typically not viewed by IRBs as constituting research even if they are using scientific research methods or use private identifiable information on human subjects.
What is Human Subjects Research?
- Any research activity involving living human subjects whom the investigator interacts in some way with, or about whom the investigator collects private, identifiable information. If you are collecting public information or working with existing data about human subjects, then your research does not involve human subjects and falls outside the scope of the IRB review process.
Should you Submit an Application to the IRB?
If you can answer "yes" to any of the below, an application to the IRB will be required:
- Does your study involve living human subjects that you will be interacting with?
- Does your study involve the collection of private, identifiable information from human subjects?
- Does your study involve children, prisoners, or mentally disabled participants?
- Does your study involve more than minimal risk to the participants?
Exceptions from IRB Review
Federal regulations identify several research categories that are considered exempt from IRB oversight. These categories include:
- Research in conventional educational settings, such as those involving the study of instructional strategies or effectiveness of various techniques, curricula, or classroom management methods. In the case of studies involving the use of educational tests, there are specific provisions in the exemption to ensure that subjects cannot be identified or exposed to risks or liabilities.
- Research involving the analysis of existing data or other materials if they are already publicly available.
- Studies intended to assess the performance or effectiveness of public benefit or service programs.
Generally, human research ethics guidelines require that decisions about exemption are made by an IRB representative, not by the investigators themselves. Consult with your faculty advisor if you are still unsure if your study should be submitted to the IRB for review. You may also submit a short description of your study to the IRB Chair and let the IRB help you make a determination.