Office of Research

Guidance & Resources

What Needs to Be Reviewed?

IRB review is required for all human subjects research conducted by faculty, staff, and students, on- and off-campus, regardless of the funding support, if any, for the project.

Two initial questions researchers should consider are:

(1)   Does my particular project meet the definition of research in the regulations? and

(2)   Does my particular project involve human subjects?

(1) According to Federal regulations governing research with human subjects (45 CFR 46), Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." [45 CFR 46.102(d)] 

The core of this definition is "a systematic investigation...designed to develop or contribute to generalizable knowledge." It should be noted that the IRB considers the definition of "a systematic investigation" to vary widely depending on the discipline of the investigation and recognizes that it might be more appropriate in some fields to refer to research results as transferable, rather than generalizable.

The IRB relies on the judgment of the PI (Principal Investigator) when considering whether or not a project is "contributing to generalizable knowledge," rather than making a determination of whether or not a project constitutes research based solely on the criterion of public presentation / publication. We do this because we recognize that many factors other than public access play into the generalizability or transferability of particular studies. And we work under the assumption that the PI is the person who is most likely to be able to make an accurate judgment as to whether or not a particular project will be contributing to generalizable knowledge.

(2) Human subject means "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information" [45 CFR 46.102(f)].

Generally speaking, information coming from experience or opinions is not likely to be replicable across people, even in similar situations, and thus means the data are "about" the individual from whom they are gathered. In contrast, factual information should not vary depending on the respondent. Thus the collection of factual data generally does not result in the "informant" becoming a human subject. A few examples of questions that are likely to elicit responses drawing on experience or opinions are "What is your projection of next year's sales data?," "What would be the best ways to improve this system?," and "Has this change in policies impacted the morale of employees?" A few examples of factual questions are "Does this organization have a policy for parental leave?," "What is the annual input into this system?," and "When did this company implement its new inventory structure?"

For assistance in determining whether or not a particular project constitutes research involving human subjects, please contact us.