Secondary Use of Existing Data

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⇐Back to Step 1: Is IRB Approval Required? 

Secondary research is the use of data or specimens from human participants for a separate purpose than its original intended use. The data was originally collected to test a different hypothesis or question or it was collected for the purpose of clinical review. This type of research is most common at WKU when analyzing data sets, medical chart review, and past data to test a separate question. 

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• Data collected for non-research- student records, medical records, non-research public data sets
• Data collected for a research study used for a project it was not initially approved for
  • Example: using data sets from previously approved studies to answer a different question or test a new hypothesis. 
• Data which contains information that can be linked back to individuals, even if it is de-identified
• Data sets in which faculty advisors obtained which students are using for their own independent projects
  • Note that if the scope and hypothesis of the project differs from the original Principal Investigators approved research, the student using the data for their own project will need independent IRB approval.

When in doubt contact The Office of Research Integrity ori@wku.edu. 

 

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You will complete the Human Subjects Application, only filling in information through Section A.

• How will/did you obtain access to the data? This will include information such as if it is publicly available or if you have permissions to access the data intended to be used. 
  • If this is publicly available data sets please include links to the data sets if available.
• What does the data consist of? This includes types of data sets, where the data originated from, if there were audio tapes or journal entries, and if the data was de-identified before your access.
• How are you using the data? This includes information such as how easy it could it be to conclude the identity of participants, if this is being combined with other data sets, as well as your hypothesis and theory for the need of the data set for research.
• Can participants be linked to their data? This includes the following questions:
  • Is the data de-identified? If not, how will it be de-identified?
  • Who prepared the data for you? 
• A letter or email of permission/cooperation is needed if accessing non-public data

 

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1. A researcher wishes to use a publicly available data set from the National Survey of Student Engagement to study the relationship between student engagement activities and graduation outcomes at public universities.

• Why IRB review is required: This data set, while publicly available, is being used for a research purpose that it was not originally intended for. 

2. A researcher obtains access to a state health department database containing identifiable information for the purpose of a research project. 

• Why IRB review is required: This requires access to identifiable health-related records. It is important here to also explain how you will be obtaining access to these records and if a Data Use Agreement is necessary. If a Data Use Agreement is not needed please provide a letter or email of permission from the state health department giving you access to the data.

3. A researcher completed a project 2 years ago, while in discussion with a colleague they developed another question they would like to study using this data collected. 

• Why IRB review is required: This research is using data that the Principal Investigator collected and analyzed for a different hypothesis and question than the new proposed research would be for. Please include an email or letter from the original PI stating permission to use the data for your research. 

4. A graduate student is working on their thesis and would like to use a data set that their faculty advisor has from past research. The data is de-identified and the student will be presenting their own hypothesis and research from the data used.

• Why IRB review is required: The student, while on the project with the faculty advisor, is using the data for a different purpose than it was intended upon approval. The student will need a separate IRB approval describing their own research. 

 

For more information and additional resources please visit https://irbo.nih.gov/irb-review/secondary-research/ 

If you have questions about secondary use of existing data or whether you need IRB approval, please contact us!