Human Research Protection Program: Policy
Existing Datasets
Policy
Adopted By: All Campus IRB
Adoption
Date: November 1, 2001
Purpose: In
many areas of the social sciences, one of the most common methods of research
is secondary analysis of publicly available files of data collected from
surveys. One of the main sources of such data is the federal government (e.g.,
Bureau of Labor Statistics). Increasingly, federal agencies require that social
science investigators make data collected with assistance of federal funds
publicly available. In addition, social science professional organizations and
journals are establishing the norm that investigators make data sets used for
the production of published scholarly papers accessible in public use data
files to encourage scholarly replication of research.
In response, UW–Madison’s Institutional Review
Boards (IRBs) have developed a policy that research projects involving analysis
of secondary data from the following datasets/repositories will NOT require
prior IRB approval:
Policy
I. Analysis of Secondary Datasets
A. Research projects involving analysis of secondary data from the
following datasets/repositories will NOT require prior IRB approval:
·
Better Access to Data for Global
Interdisciplinary Research (BADGIR)
·
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
·
University
of Wisconsin-Madison Data and Information Services Center (DISC)
·
U.S.
Bureau of the Census
·
Luxembourg
Income Study (LIS)
UW-Madison IRBs have determined that data in the above
listed datasets has been stripped of identifiers and is publicly available. As
a result, research using this data does not rise to the level of “human subjects
research,” under the federal Common Rule, 45 CFR Part 46 and
UW-Madison policies, and, therefore, does not
require IRB review. See, Defining Human Subjects Research Policy.
Note: Research projects that merge more than one dataset in such
a way that individuals may be identified are not covered by this policy, and
require prior IRB approval.
A. Datasets that may qualify for inclusion on UW–Madison's list of
approved data sources include:
1. Public use datasets 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
responsible use statement)
2. Survey data distributed by UW-Madison principal investigators who can
certify that:
a. the data collection procedures were approved
by an IRB that satisfies the Common Rule criteria for an IRB, and
b. the dataset and documentation as distributed
do not contain information that could be used to identify individual research
participants.
B. Investigators must submit the following information on potentially
eligible datasets to the IRB office prior to conducting research:
1. Name of dataset
2. URL of the dataset or other information on how to obtain the dataset
3. Abstract (one page maximum) describing the content of the dataset and
its potential use
