Human Research Protection Program (HRPP)

Office of the Vice President for Research

Research Using Publicly Available Data Sets: UM Policy
(revised April 2008)

A common research method involves secondary analysis of publicly available survey data. The federal government provides public access to several important data sets (e.g., U.S. Bureau of the Census), and many federal funding programs now require that researchers make the data they collect publicly available. Likewise, many professional organizations and journals have a standard requirement that research data sets of published works be made accessible to encourage scholarly replication of research.

Under the federal regulations for human subjects research (45 CFR Part 46) publicly available data sets that are stripped of identifiers do not require IRB review. Because it may be difficult to understand the definition of "publicly available" and also, what "stripped of identifiers" means, upon recommendation of the IRBs, the university has instituted the following policy for research projects involving certain data sets:

Policy for Use of Publicly Available Data Sets

Research projects involving analysis of secondary data from any one of the following data sets/repositories will NOT require prior IRB approval, unless the archive hosting the data explicitly requires prior IRB approval before releasing the data for use. Note: Research projects that merge more than one data set are not covered by this policy, and require prior IRB approval.

This policy was first approved by the IRB Council in Apirl 2006 and is revised as new data sets are approved by the Council.

Submitting a Data Set for Pre-approval
Data sets that may quality for inclusion on UM's list of approved data sources include:

To obtain pre-approved status for potentially eligible data sets, investigators must submit the following information for review by a subcommittee of the Council: Submit the information to Judy Nowack, chair of the IRB Council.

If the subcommittee approves the request, the data set will be added to the list.