You are required to submit a formal application if your proposed study meets both of these conditions:

1. It constitutes researchand
2. It is conducted on human subjects.

The quiz below is designed to determine if your study meets both criteria. If it does, a formal application and IRB approval is required before research begins. The IRB cannot approve research after it has been done.

Part 1: Does my study constitute research?

According to the Code of Federal Regulations, research means “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)].

The federal Common Rule specifically excludes certain types of investigations from the definition of “research.” As such, these kinds of investigations are not subject to IRB review: “oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focuses directly on the specific individuals about whom the information is collected.”

Answer YES or NO to the following questions:

  1. Do you expect or intend to publish the results of your study?
  2. Do you expect or intend to present the results of your study in a public setting outside of Carleton, such as a workshop, conference, or poster session?

If your answer was NO to both of these questions, your study is not considered research in the Federal definition. Formal application is waived and you are free to begin your study.

If your answer was YES for either of the questions, your study is considered research. Continue to Part 2.

Part 2: Is my study considered research on human subjects?

Answer YES or NO to the following questions:

  1. Will people themselves be the subjects of study? (If you interview a physics professor to learn about black holes, she is not a human subject of your investigation. If you interview her about her experiences as a physicist, however, she is a human subject.)
  2. Will the study involve interacting with living people?
  3. Will you gather information that would ordinarily be private (e.g. personal beliefs)?
  4. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g. their homes)?
  5. Will your study involve a vulnerable population (e.g., prisoners, minors, undocumented immigrants, etc.) and/or involve participants outside of the United States?

If you answered NO to all five of these questions, your study is not considered to involve human subjects. You do not need to apply for IRB approval of your research, and are free to begin your study.

If you answered YES to question 1 AND to one or more of the other four questions, your study is considered to involve human subjects, and you do need to apply for IRB approval of your research.

Proceed to our How Do I Apply? page to begin the process.

Still not certain?

If you are still not sure whether or not your study is considered “research on human subjects,” go to the Glossary page to see detailed explanations of what does and what doesn’t constitute “research on human subjects” under the federal regulations.

You may also direct further questions to the IRB chair, Anita Chikkatur, IRB Chair and Professor of Educational Studies, 507-222-4877 or 1 N. College Street (5-EDUC), Northfield, MN 55057.