You are here: American University Institutional Review Board Review of Research Involving Secondary (Existing) Data Sets

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Zembrzuski, Matt
IRB Coordinator

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Institutional Review Board 4400 Massachusetts Avenue NW Washington, DC 20016 United States

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Most research that utilizes secondary (existing) data sets does not meet the definitional criteria for "human subjects" research and, therefore, does not require IRB approval. The purpose of this document is to provide guidance for researchers on whether or not they are required to apply for IRB approval when using secondary (existing)data sets.

THERE IS NO NEED TO APPLY FOR AN IRB APPROVAL, if your data are:

  1. Publicy available (e.g., through a public website or publication or by subscription) AND
  2. De-identified so that it is impossible to link a record to a particular individual.

The research using this data set is not "human subjects"research and is not subject to IRB approval.[Examples include: Inter-University Consortium for Political and Social Research (ICPSR); National Election Studies; National Center for Health Statistics]

RESEARCHERS MUST APPLY FOR AN IRB APPROVAL if their data are both:

  1. Not publicly available AND
  2. Not de-identified making it possible to link a record to a particular individual

The research using this data set is considered "human subjects" research and must be submitted in Cayuse IRB and approved by the IRB.

Maybe: Utilize the Determination Tool to check if further IRB interaction is needed.

RESEARCHERS MAY NEED TO APPLY FOR AN IRB APPROVAL, if their data are any of the following:

  1. Not publicly available OR 
  2. Not de-identified so that it is possible to link a record to a particular individual OR
  3. Coded so that it would be possible to link a record to a particular individual if one possessed the key 

The research using this data set MAY BE considered "human subjects" research. In such cases, please, use the Determination Tool to the IRB in order to determine if your research qualifies as "human subjects" research.