Do I Need to Apply?
Does My Research Project Require an IRB Application?
You are required to submit a formal application if your proposed study meets both of these conditions:
- It constitutes research, and
- It is conducted on human subjects.
The questions below are designed to help you determine if your study meets both criteria. If it does, an application approved by the IRB is required before research can begin. The IRB cannot approve research after it has been done.
Part 1: Does My Study Constitute Research?
According to the Code of Federal Regulations (45 CFR 46 or “Common Rule”), research means “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Answer YES OR NO to the following questions:
- Do you expect or intend to publish the results of your study?
- Do you expect or intend to present the results of your study in a public setting, such as a workshop, conference or poster session?
If your answer is NO to both of these questions, your study is not considered research based on the Federal definition. No application to the IRB is required, and you are free to begin your study.
If your answer is YES for any of the questions, your study is research. Continue to Part 2.
NOTE: The Common Rule specifically excludes certain types of investigations from the definition of “research,” including oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focuses directly on the specific individuals about whom the information is collected.
Part 2: Is My Study Considered Research on Human Subjects?
Answer YES or NO to the following questions:
- Will people themselves be the subjects of the 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.)
- Will the study involve interacting with living people?
- Will you gather information that would ordinarily be private (e.g., personal beliefs)?
- Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., in their home)?
If you answered NO to all four 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 three questions, your study is considered to involve human subjects, and you must submit an application to the IRB and receive approval before beginning your research.
Part 3: Is My Human Subjects Research Project Exempt or Non-exempt?
Certain research is exempt from HSIRB oversight. Exemption categories include:
- Educational Setting (PDF)
- Surveys, Tests, Interviews, Observations (PDF)
- Benign Behavioral Interventions (PDF)
- Secondary Use of Identifiable Data or Specimens (PDF)
Due to the potential for conflict of interest, investigators are not authorized to make an independent determination that their human subjects’ research is exempt.
Both Requests for Exemption and Requests for Approval of Non-Exempt research may be submitted using the HSIRB online application system. Modification requests to existing protocols may be also submitted using this system. Visit our application page for more information.
Student Research—exempt or non-exempt—requires a faculty sponsor. In addition to the correct application form, a Faculty Sponsor Assurance Form must be submitted by the faculty sponsor before review can begin. This form is now part of the online HSIRB Application for Exempt/Non-Exempt protocols and the online Modification form.
Still Not Certain?
If you are still not sure whether or not your study is considered “research on human subjects,” please contact the HSIRB (email@example.com). You may also direct further questions to the IRB Chair, Professor Jessica Good (firstname.lastname@example.org) or IRB Vice Chair, Ms. Tiffany Johnson (email@example.com).
For questions regarding the Submittable application platform, contact the HSIRB (HSIRB@davidson.edu).