Human Research Protection Program: Policy

Existing Datasets Policy

Adopted By: All Campus IRB

Adoption Date: November 1, 2001

Revised by: HRPP Advisory Committee

Revised on:  March 14, 2013

Purpose:  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.

 

Policy on Analysis of Secondary Datasets

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 publically 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:

 

1.     The data set(s) is (are) published and publicly available without restriction (e.g., data are published by a reputable source in a publicly-available journal, textbook or web-site) and neither the UW researcher nor any collaborating researcher on the project(s) has access to links that would connect the data to the individuals from whom they were derived.

 

2.     The data set(s) are publicly available to researchers and others, but the data holder requires a “responsible use statement” or similar attestation to ensure appropriate use and protection of the data.  Such an agreement or attestation may be automated. In this case, neither the UW researcher nor any collaborating researcher on the project can have access to any links that would connect the data to the individuals from whom they were derived, nor may any researcher on the project attempt to re-identify any person from whom the data were derived.

 

3.     The researcher will obtain a data set available from a Federal or State agency and will enter into an agreement with the data provider that includes language that a) the data provided to the researcher does not contain any identifiers, including those specified under the HIPAA Privacy Rule; b) if the data are coded, the data provider will not release a link to the code to the researcher; and c) the researcher receiving the data set must agree to not attempt to re-identify any person from whom the data were derived.

 

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 Datasets, http://my.gradsch.wisc.edu/hrpp/10280.htm for examples of the types of secondary datasets that do not require prior IRB approval.