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.
- 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
- The University of Michigan Health and Retirement Study (HRS)
- Unrestricted data sets only
- U.S. Bureau of the Census
- Panel Study of Income Dynamics
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:
- Public use data sets posted on the Internet that include a
responsible use statement or other confidentiality agreement for
authors to protect human subjects (for an example, see the ICPSR's
confidentiality review:
http://www.icpsr.umich.edu/access/deposit/conf-review.html)
- Survey data distributed by UM principal investigators who can
certify that:
- the data collection procedures were approved by an IRB that
satisfies the Common Rule criteria for 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 potentially eligible data sets,
investigators must submit the following information for review by a
subcommittee of the Council:
- Name of data set
- URL of the data set or other information on how to obtain the
data set
- Abstract (one page maximum) describing the content of the data
set and its potential use.
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.