Updates regarding the use of Existing and Archival Data

In many areas of the social sciences, one of the most commonly used methods of research is the secondary analysis of publicly available files of data.

The IRB is acquainted with the fact that the federal government as well as large data consolidation bureaus and consortiums provide public access to many data sets. Additionally, many federal funding programs as well as social science professional organizations and journals now require that researchers make the data they collect publicly available to encourage scholarly replication of research. Data may also available from previously IRB approved protocols where the data sets do not contain information that could be used to identify individual research participants

Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets are exempt from IRB review:

* as long as the data come from sources that are publicly available
* and the data is deidentified and uncoded and stripped of identifiers.

Therefore, the IRB has determined that investigators who plan to use these publicly available, de-identified sources do not require prior IRB review. These means no application is required.

The IRB has created a list of pre-approved data holders whose archives include publicly available, de-identified data. Review this list and follow the respective links below to learn more about the access and download procedures each data source.

Go to the IRB website (http://www.umbc.edu/research/HARPO/IRB/IRBspecialtopics.html#archival) for more information about this process and to obtain the list of pre-approved data holders.

Cautionary note # 1: If you are designing a research project that merges more than one public data set and you recognize that this may increase the risk of identification of individual research participants, please contact the Human and Animal Research Protections Office at 5-2737 or HARPO@umbc.edu.

Cautionary note #2: Data holders whose archives are available on a restricted basis will require the submission of an application for Expedited or full board review.