“Research involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.” (§46.101(b)(4))
Exempt Category 4 - Secondary Research is commonly referred to as “previously collected data,” “existing data,” or “secondary data.” Research that falls under Exempt Category 4 does not involve new recruitment of human participants. In order to qualify for this exemption, the materials to be used in the research must satisfy two criteria:
The following guide will explain how to submit a protocol for existing data to Teachers College (TC) Institutional Review Board (IRB) review.
All submissions to TC IRB should include a Primary Investigator (PI) survey (submitted through TC Mentor IRB) and a completed IRB application (IRB Application Template). A Sample Application for Existing Data can also be downloaded and used for reference. For detailed information on how to submit to TC IRB, please visit our How to Submit page.
On the IRB Application, there are a number of questions that ask about “new data collection” or “recruitment efforts.” For these questions, you may respond with “Not Applicable” when submitting an Exempt Category 4 protocol, because no new data will be collected as part of the study parameters.
Researchers should clearly indicate the identifiers that will not be included with the final dataset.
Data retrieved from an external institution or individual should be transferred via secure methods and stored in a safe location. When receiving datasets from external institutions, researchers are required to abide by guidelines and policies set in place by the data owners. Failure to do so can result in consequences from both the external institutions and TC IRB. Data protection measures should also be carefully considered. Researchers are advised to consider the following documents per their specific research needs:
In most cases, the following documents are not required for an Exempt Category 4 TC IRB protocol submission:
Prospective vs. Retrospective: Prospective studies involve individuals over time, where data is collected about them as their characteristics or circumstances change. These studies are not considered Exempt Category 4. Retrospective studies must have all data or specimens in existence prior to the start date of data analysis in order to qualify for exempt review. IRB protocols can be submitted for existing data before data collection has ended. However, the protocol activities cannot begin until data collection is complete.
Public sources of data include local telephone directory information, publicly available websites, open use datasets, etc. Student records, which are covered by the Family Educational Rights and Privacy Act (FERPA), are not public records. These (de-identified) records can be considered existing data, as the information was collected prior to the start of the study protocol.
Existing data can help reduce new data collection burdens, and can also show how data evolves over time. Researchers can consider the following ways to explore existing data:
An existing data set may be suitable for answering a new research question or exploring a hypothesis. Secondary analysis may be a researcher's preferable option since it can be completed in less time, for less money, and with far lower risk to research subjects. A researcher must carefully consider if the existing data quantity and quality are adequate to answer the proposed research questions.