Navigating the IRB When Using Deidentified Secondary Data Sources

This article offers a step-by-step tutorial on the information you will need to include in your IRB application to use de-identified secondary data in your research project. Deidentified means that there are no direct or indirect links to patients’ identifying information, such as names, addresses, dates of birth, social security numbers, medical record numbers, or other identifying information. Many national survey data sources are de-identified. Most studies using de-identified data are considered “Not Regulated” by the IRB and the applications are brief. 

 

An additional guide to navigating the IRB when using secondary data that includes identifying information is linked below. 

 

Please note that this tutorial is only applicable to the University of Michigan IRB (EResearch) system and may not apply to other institutions. The language included below is purely suggestive, and may need to be modified depending upon your project needs. If you have specific questions or would like further consultation, please email our team at efdc-datadesign@umich.edu. 

 

  • Questions 1.1-1.3 are standard study questions that ask for your study title, name of Principal Investigator and study team members. 

  • Question 1.8 asks for a Project Summary. This should include a summary of your research question, hypothesis and relevant background information. Here it is important to include that your project is secondary data analysis, information on the data source and what level of identifying information is available to you as a researcher (if any).

  • Question 1.9 asks for which IRB this application should go to. This depends on if your affiliation is within Michigan Medicine or the Medical School (IRB-MED), or campus (IRB-HSBS). 

  • Question 1.11 asks for study duration. I think it is best to be generous with this estimate in case of delays. 

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  • Question 1-1.1 offers a list of options to determine the study type. Select the third option, “Activities Not Regulated as Human Subjects Research”. 

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  • Questions 1-2.1-2.9 are standard study questions related to who initiated the study, if there are students working on the project, if the study is related to cancer or cancer risk, if the merits of the study have been reviewed and if it is a clinical trial. The answers to these questions depend upon the focus of your specific project. 

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  • Questions 2.1-2.4 ask about the financials of the project, including the PAF. For secondary data projects, if you do not have external funding, you will not need a PAF. 

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  • Question 3.1 asks about study functions performed at University of Michigan. You will want to select “Secondary analysis”.

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  • Question 4-1.1 asks about categories of research determined to be Not Regulated. Here you can select “Research Using Publicly Available Datasets”. 

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  • This brings you to the last page of the application, question 44.1. This question is for additional Supporting Documents, which is optional. You may not need to add anything here. 

 

After that, the system will prompt you to do an error check and you should be all set to submit your application! 

 

If you run into additional issues, or need help, please contact our team at efdc-datadesign@umich.edu. 

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