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Submissions :: Protocol review process :: Expedited/Exempt Review :: Exemption :: Archival data

Archival Data

Archival data are any data that are collected prior to the beginning of the research study. The data contains information that can be linked to individuals (though not necessarily to the individual’s identity), otherwise it is not considered human subjects research and does not qualify for IRB review. The data are also the primary source (versus a secondary source where the data was analyzed for another publication). The federal regulations allow for IRB’s to exempt research using archival data when certain conditions exist, including stripping a participant’s identity from the data, so often we talk about archival data from an exemption perspective.  However, there are conditions where archival data is not considered exempt.  In order for the Board to assess the risks to the participants through the use of archival data sources and make recommendations for ethical use of the data, they will need to know the following:

  • How did you obtain access to the data? The Board will need to know if the data are publicly available or if there are restrictions for accessing the data.  If the second is true, the Board will need to know how you obtained permission to access the data.
  • What do the data consist of? The Board will need to know if you are using data sets, video tapes, audio tapes, journal entries, transcripts, etc.  If you are using data sets, they will need to know what data fields you will use.  
  • Can the participants be linked to their data? The Board will need to know in what form you receive the data.  Can the data be de-identified? Are the data linked and stripped of identifiers?  Who prepared the data for you?  Will you merge multiple data sets? 

The first two questions are generally determined by the data’s source.  Archival data generally falls under the following categories:

In order to answer the final question, it is important to understand what an identifier is and to understand how the data were collected.

In addition, there are specific rules for using archival data in an educational setting, particularly in regards to using student records. Please see Education: Archival Data for more information.

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