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Research Reporter :: April 2006
Research Information from the University of Michigan

Some public data sets now pre-approved by IRBs

Research at the University often involves the analysis of data from publicly available data sets, such as the data collected by the U.S. Bureau of Census. Indeed, sources of such public data are growing. The federal government maintains several important sets. Many federal funding programs now require that researchers make data they collect publicly available. Pre-approved data sets:
Secondary analysis research using these data sets
does NOT require IRB review
  • Inter-University Consortium for Political
    and Social Research (ICPSR)
  • National Center for Health Statistics
  • National Center for Education Statistics
  • National Election Studies
  • Roper Center for Public Opinion Research
  • U.S. Bureau of the Census

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 federal regulations that protect human subjects, research that uses publicly available data sets that are stripped of identifiers that could link information back to individuals does not require Institutional Review Board (IRB) review.

For a researcher contemplating a project, it can be difficult to assess whether a particular data set meets the official definition of "publicly available" or "stripped of identifiers" and assess whether the project will require review by the IRB.

To smooth the path of such research, at the recommendation of the IRBs, the University has designated some data sets as approved for human research without IRB review.

Note that IRB approval may be required if the archive hosting the data explicitly requires IRB approval before the host will release the data for use. Also, research projects that merge more than one data set are not covered by this policy; IRB approval is required.

The data sets that are on the approved list are: Inter-University Consortium for Political and Social Research (ICPSR), National Center for Health Statistics, National Center for Education Statistics, National Election Studies, Roper Center for Public Opinion Research, and the U.S. Bureau of the Census

Submitting a data set for approval
The policy also has a provision for adding data sets to the approved list. Data sets that may quality for inclusion on the approved list include:

Public use data sets posted on the internet that include a responsible use statement or other confidentiality agreement for authors to protect human subjects.
Survey data distributed by UM principal investigators who can certify that: the data collection procedures were approved by an IRB, and the data set and documentation as distributed do not contain information that could be used to identify individual research participants.
To obtain pre-approved status for a data set, investigators must submit information for review by a U-M IRB Council subcommittee:
  • Name of data set
  • URL or information on how to obtain the data set
  • Abstract describing the content of the data set and its potential use (one page maximum).

Submit this information to: Judy Nowack, chair of the IRB Council, and Assistant Vice President for Research. If the subcommittee approves the request, the data set will be added to the list. The list is available on the UM Research Web site under "human use" policies, http://www.research.umich.edu/policies/um/datasets.html


April 2006

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