UW-Madison 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 because their use does not constitute research involving human subjects.
Adopted By: All Campus IRB
Adoption Date: November 1, 2001
Revised by: HRPP Advisory Committee
Revised on: March 14, 2013
In many areas of the social sciences and increasingly in health sciences research, 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) or its contractors. In addition, federal agencies increasingly require that social and health science investigators make data collected with assistance of federal funds publicly available. Further, 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 because their use does not constitute research involving human subjects.
In order for research to constitute "human subject" research under federal law (45 CFR 46.102), the data used in the research must either have been obtained by the investigator through intervention or interaction with the subject of the data, or the data must include identifiable private information about the subject of the data. As a result, research which involves ONLY the analysis of publicly available data as described below does not constitute human subject research and does not require prior IRB approval.
Research projects involving analysis of secondary data will NOT require prior IRB approval in the following situations:
UW-Madison IRBs have determined that data satisfying one or more of the above criteria never contained or have been stripped of identifiers and are publicly available. As a result, research using such data does not meet the definition of research involving human subjects 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.
Any questions regarding whether a data set meets these requirements should be referred to the IRB Office that would be expected to review the use of the data if the project qualifies as research involving human subjects. See, List of Approved De-identified Publicly Available Datasets for examples of the types of secondary datasets that do not require prior IRB approval.
|Keywords:||Datasets database existing publicly available research secondary data not human subjects research||Doc ID:||29465|
|Owner:||Ryan M.||Group:||Office of the Vice Chancellor for Research and Graduate Education and Graduate School|
|Created:||2013-04-15 10:37 CST||Updated:||2014-10-31 10:52 CST|
|Sites:||Office of the Vice Chancellor for Research and Graduate Education and Graduate School|
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