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Submissions :: Before you submit :: Activities that require IRB Review :: Pre-studies, class projects

Pre-Studies, Class Projects

Preliminary study activities, class projects, and other exploratory activities can be a gray area as to whether they need IRB approval.  For example, if you have an assignment for your research methods class to conduct a survey, compile the results, and submit the paper for a grade, this activity does not satisfy the definition of research for an IRB review because the intent is not to generalize this information (instead the intent is to practice conducting research for a grade in a class).  However, let’s suppose that you want to use this data for a thesis that will be published as part of your graduation requirement, which does meet the definition of research.  Even though the initial collection did not fall under IRB review, because you want to use the data in a context that does require IRB review, the use of the data can be problematic. The federal regulations state that researchers cannot collect data before an IRB approves the data collection, except in the case where data was collected without the intent to conduct human subjects research.  In this case, it can be argued that the data was initially collected without the intent to conduct human subjects research (at least according to the IRB definition of research), so the Board can allow its use.  The catch here is that the Board will review the data collection process and will only approve the use of the data if the data were collected in an ethical manner.  Going back to the survey example, if the surveys were collected in a manner that did not protect confidentiality, they may not allow you to use the data.  Or if you conducted interviews, the Board may request that you seek the participants’ consent to use their data in the new study. In some cases, it may be easier to obtain IRB approval for the pre-study data collection than to try to navigate obtaining approval after the data is collected. If you think that your data collection will be a gray area or if you have already collected data, we recommend that you contact our staff for further assistance.  They can help you determine if you should submit a protocol before you collect data and/or give you advice on how you can collect your data so that the Board can approve its use for a potential future study.  For data that is already collected, the staff can help you to understand how that data can be used in a study.

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