Policy on Secondary Analysis of Existing Datasets
Adopted by Carleton IRB:
One common approach to empirical inquiry in the social sciences involves the secondary analysis of data that have been made available to the public. While academic data archives, such as the Inter-University Consortium for Political and Social Research, have offered data warehousing and distribution services for associated institutions for decades, the growth of the internet has broadened public access to a wider range of data sources and vastly increased ease of access. Government agencies, non-governmental organizations and academic journals with requirements that data be made available for replication studies are just a few of the places scholars may find existing datasets.
IRBs at a number of institutions have instituted policies that indicate that the use of these existing data, when they have been stripped of any identifying information about the human respondents and made publicly available, do not constitute “research with human subjects” under the federal common rule 45 CFR Part 46. Consequently research using these data does not require IRB review.
This policy DOES NOT apply to data acquired from these archives that includes identifying information (typically acquired only through special application to the archiving body) or research projects that merge one or more datasets in a manner that allows individuals to be identified. These projects will still require IRB approval.
Some examples of data archives where publicly available data meets these requirements and does not require IRB approval:
This is not intended to be an exhaustive list of public-use data sites. Data made available though Carleton’s Library and other internet data sources may also fall under this policy if the site where the data has been made available satisfies the following criteria:
- It includes a ‘responsible use statement’ or other confidentiality agreement for the authors to protect human subjects.
- The initial data collection was approved by an IRB that meets the Common Rule criteria for an IRB (including non-US research oversight bodies that meet Common Rule standards)
- The dataset and documentation as distributed do not include information that could be used to identify individual study participants.
Investigators who intend to use existing data from on-line or other sources and who have questions about whether this policy applies should email the Chair of the IRB and include the following information: 1) the name of the dataset, 2) the URL of the data archive site (or other information on how the data can be obtained) and 3) a brief abstract describing the dataset and its possible use.