When Does a Study Require IRB Approval?

Institutional Review Board at the Minnesota Department of Health

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When is approval required? 
When is IRB approval not required?

MDH researchers engaged in human subjects research must get IRB approval before gathering or analyzing data for the study.

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigations follow a plan for answering a question, testing a hypothesis, or developing a new theory or intervention that may include:

• Collection of biospecimens, quantitative data, or qualitative data
• Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
• Collection of data using experimental designs such as clinical trials
• Observation of individual or group behavior
• Analysis of information or specimens collected for non-research purposes to answer a research question

Contribute to generalizable knowledge means that the purpose of the study is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include:

• Presentation of the results at meetings, conferences, seminars, poster presentations, etc.
• The knowledge contributes new information to an established body of knowledge
• Other investigators and practitioners may benefit from this knowledge
• Publications including journals, papers, dissertations, and master’s theses

Participants or subjects must be living, and the data must be about them to be considered human subjects. In addition, the data must be identified with or traceable to the subject. Anonymous information or specimens are not considered human subjects. 

An institution is considered engaged in research when its employees or agents (e.g., contractors or grantees) fund the study or obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. 

Related: Decision Tool: Am I Doing Human Subjects Research? (National Institutes of Health)

MDH collects and analyzes data to do its work, and quite often these activities do not meet all elements of the definition of "engaged in human subjects research." The following examples are some situations that do not require IRB review.   

• MDH is only providing data gathered for non-research purposes for a research project as part of its obligation to share publicly available data upon request; MDH is not participating in the design, analysis, or interpretation of findings for the study
• If the study does not include any interaction or intervention with human subjects and does not include any access to identifiable private information, then the project does not require IRB review
• The data is needed to administer, evaluate, or report to the funder on a well-established intervention or public health activity with no innovative components, and there is no expectation to publish or share the findings more broadly than to the funder 
• The participants are solely providing information about a policy or process and not about their own thoughts, feelings, behavior, status, etc. For example, a study consisting of interviews with clinic staff about the efficiency of a new method for administering a vaccine. For this study, the focus is on the method, not on the clinic staff themselves.

The MDH IRB is best able to determine whether your study requires IRB approval. If you have any doubt whether your study requires IRB approval, we encourage you to submit an application for preliminary review. The application requires you to answer just a handful of questions about your study, and we typically respond within 2-3 business days. 

Related: 
Types of review
Forms and applications