What is Reviewed by the IRB
The IRB reviews all proposed doctoral projects and studies. However, the level of review depends on several factors (see Figure 1 - IRB Decision Tree). This section explains what the terms research and human subjects mean so that you can more readily interpret the figure.
Not all work that we would colloquially call research is considered research under the Common Rule (the Common Rule is a short name for The Federal Policy for the Protection of Human Subjects and was adopted by several federal agencies in 1991 and revised in 2018).
To make things even more interesting, not all research involves human subjects. Two questions are asked to determine if a proposed activity is research with human subjects.
Question 1: Does the activity meet the regulatory definition of research?
The Common Rule defines research as: "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102(d)). Thus, two factors are assessed:
✔whether the activity involves a systematic investigation and
✔whether the activity is designed to develop or contribute to generalizable knowledge (there is no regulatory guidance on the meaning of generalizability).
Because systematic investigation and generalizable knowledge are not easily operationally defined, USU's IRB Review Form begins with a screening checklist that will assist the IRB in determining whether or not your proposed activity is research. Most DNP students propose projects that are not deemed research by this definition and will receive the determination of "Not Human Subject Research" per Figure 1.
If, and only if, the activity is deemed research, then a second question is asked.
Question 2: Does the research involve human subjects?
A human subject is defined as "a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information" (45 CFR 46.102(f)(1),(2)).
USU's IRB Review Form begins with a screening checklist that will assist the IRB in determining whether or not your proposed activity is research with human participants. DBA and EdD students proposing systematic literature reviews or studies using de-identified archival data will receive the determination "Not Human Subjects Research" per Figure 1.