IRB Quiz

Project teams, educators, clinicians, and administrators can use the IRB Quiz to organize an early review of whether an activity may be research, quality improvement, or a combination of both. An IRB assessment is most useful when the project’s purpose, procedures, information sources, and intended audience need to be described clearly before an institutional review board discussion.

What This Assessment Explores

Questions cover purpose, procedures, selection, data, and links with people or private material. The profile has three dimensions:

• Generalizable Knowledge Intent (0-15) reflects whether the project is designed to produce knowledge beyond one immediate operational decision: Local-purpose emphasis (0-5) keeps intended use within one service, class, or organization; Mixed intent (6-10) joins local improvement with transferable lessons; Broader-knowledge emphasis (11-15) aims its questions, claims, and outputs at other settings or populations.
• Human-Participant Connection (0-15) reflects connections with living individuals through interaction or intervention, or through identifiable private information or biospecimens: Indirect connection (0-5), Potential connection (6-10), and Direct connection (11-15).
• Systematic Investigation (0-15) reflects how strongly the project has a defined question, planned procedures, selection logic, and analysis: Limited structure (0-5), Developing structure (6-10), and Strong structure (11-15).

As an IRB screening questionnaire, it flags features for institutional discussion.

Methodology and Scientific Basis

Each item offers four response options describing project conditions, not agreement with a personal statement. Choices span local or broader aims, informal or planned procedures, and indirect or direct connections with people, private information, or specimens. Answers are most useful when the team can explain the facts behind each option.

The result presents three displayed dimensions with their bands. Read together, they show how knowledge intent, human connection, and investigative structure relate; the dimensions may point in different directions and should be considered as a set.

Bass and Maloy (2020) offer the closest conceptual comparison, distinguishing human-subjects research, quality improvement, and projects containing both. The questionnaire is conceptually consistent with OHRP decision charts, 45 CFR 46.102, and Carter et al. (2021), but it is not an adaptation of those published sources.

Because it is a self-report questionnaire, the result depends on the project description and the respondent’s current understanding; its displayed bands are not official regulatory thresholds, a broad-knowledge aim or publication plan does not settle status, one feature may independently require review, and uncertain cases belong with the relevant IRB.