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Analysis of Existing Data

Researchers often analyze data that they did not collect. Existing data may be data sets, but may also be interview notes or audio- or video-tapes.

Existing data may have been collected for research purposes or non-research purposes, such as driver's license information or school records.

Important: If data are provided to researchers without identifiers, the proposed research does not meet the definition of research with human subjects.

If the data are identifiable there is only one protocol application form, regardless of the type of review that will be used.

Federal Guidance Defining Identifiers

Identifiers include, but are not limited to names, addresses, phone number, social security numbers, geocodes, and images (but not voices).

Federal guidance addresses the question: "Are data ‘identifiable' if they include identification codes that could link the data to individuals?" The answer is "yes," unless the researcher and the data provider have a formal agreement stating that the key linking codes with the individual identifiers will never be provided to the researcher.

Restrictions

If data were collected for research purposes, the original agreement with the subjects must have included permission for identifiable data to be shared with other researchers.

Process

An IRB* staff member will pre-review the protocol and determine what kind of review is needed.

Exempt, Expedited, or
Full Review?

Protocols for research analyzing existing data can be exempt if identifiable data are publicly available or if the researcher strips any identifiers upon receipt of the data.

Protocols can be expedited if the only risk is a breach of confidentiality and adequate confidentiality procedures are in place.

Protocols generally require full review only when it is a requirement of the data provider.

Anticipated Approval Time

It depends upon the type of review that will be required.

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