First, you will be asked a few questions to determine if your project involves human subjects.

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This means the data provide information ABOUT individual living people, not simply collected FROM individual living people.

Information gathering interviews with key informants where questions focus on things, products, or policies, rather than individuals or their personal thoughts, feelings, or opinions, do NOT count as "data about living individuals." An example of this would be an interview with a company manager where the questions focus on the how a product is made.

Note: if you plan to obtain biological specimens (such as blood or saliva samples) of living individuals, your answer here should be 'Yes.'

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Intervention includes both physical procedures by which data are gathered (for example, veripuncture) and manipulations of the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subjects. Typical examples include face-to-face meetings, phone conversations, and physical or electronic correspondance. The distribution of anonymous online surveys qualifies as an interaction.

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Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for a specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

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Based on your responses it appears as though your project will not involve human subjects.

Assuming this is correct, and regardless of whether or not your project satisfies the definition of regulated research, IRB review and approval of your project is not required because the IRB does not have the regulatory authority to review, oversee, and/or approve projects that are not regulated research with human subjects.

In other words, you do not need to submit your project to the IRB for review.

Presentation or publication of the findings of this project is allowed; however, you must avoid claiming that your study received IRB review or approval. You are still expected to follow adequate, discipline-specific guidelines to assure that the project is being conducted in a responsible, professional, and ethical manner. 

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If you would like to request an official Determination letter from the Office of Research and Sponsored Projects Operations that your project is Not Regulated Research, please provide the following information. The ORSPO will respond within 3 business days of submission.

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Based on your responses it is possible that your project will involve human subjects.

That's the first step. Next, you must determine whether or not the project meets the federal definition of regulated research.

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Next, you will be asked a couple of questions to determine if your project involves regulated research.

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

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A systematic investigation is an inquiry that is characterized by a predetermined and organized method of data collection and analysis to study a specific topic, answer a specific question, test a hypothesis, or develop a theory. 

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This is the most challenging question to answer when determining if an activity meets the definition of regulated research. A study that is designed to develop or contribute to generalizable knowledge applies and/or expands upon existing scholarly or scientific knowledge and will support conclusions that hold (generalize) across contexts and populations.

Several common activities involving human subjects and systematic data collection are similar to regulated research but do not satisfy this criterion. Examples include Quality Improvement, Quality Assurance, Program Evaluation, and Needs Assessment. These projects usually intend to to seek feedback about and/or improve upon a specific program or process within a specific, limited setting.

Relatedly, a project involving data collection may occur within the context of a class assignment with the goal of contributing to a student's educational experience (e.g., to learn about research methods). Such projects rarely satisfy this criterion because they are not intended to contribute to generalizable knowledge.

Please note that the intent to publish or present the findings of a project does not in and of itself determine whether a project was designed to contribute to generalizable knowledge.

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Based on your responses it appears as though your planned project does not satisfy the definition of regulated research.

Assuming this is correct, IRB review and approval of your project is not required because the IRB does not have the regulatory authority to review, oversee, and/or approve projects that are not regulated research.

In other words, you do not need to submit your project to the IRB for review.

Presentation or publication of the findings of this project is allowed; however, you must avoid claiming that your study received IRB review or approval. You are still expected to follow adequate, discipline-specific guidelines to assure that the project is being conducted in a responsible, professional, and ethical manner. 

Click 'Next' to continue.

Click 'Next' to continue.

If you would like to request an official Determination letter from the Office of Research and Sponsored Projects Operations that your project is Not Regulated Research, please provide the following information. The ORSPO will respond within 3 business days of submission.

Click 'Next' to continue.

Based on your responses it appears possible or likely that your planned project does satisfy the definition of regulated research.

Your earlier responses indicate that your project probably involves human subjects and regulated research; therefore, it is likely that your project requires IRB approval prior to initiation.

In other words, you need to submit your project to the IRB for review.

Click 'Next' to continue.

The responses you provided should have resulted in feedback regarding whether or not your planned project satisfies the federal definition of human subjects research.

• If it has been determined that your project involves both human subjects and research, please proceed to the UIW IRB website to submit your project for review.
• If one or both definitions are not satisfied, please do not submit your project for review.

Refer to the IRB website for additional information on UIW's human subjects protection program and IRB, including adminstrative and IRB contact information. Feel free to contact the ORSPO or the IRB Chair with any questions about your planned project(s).

Click 'Submit' to complete the questionnaire.