Under the revised Common Rule (45 CFR 46), secondary research of data/records/biospecimens can now be deemed exempt when:
While these criteria seem relatively straightforward, it’s important to keep them in mind as secondary use or retrospective review protocols are developed. If Institutional Review Board (IRB) personnel cannot validate that these criteria are met, the research may require revision or may require a different level of IRB review.
To facilitate IRB review, ask yourself if the following are clearly described in your study protocol.
Perhaps biospecimens are collected from a department’s specimen repository under another IRB protocol. Perhaps the data will be retrieved from an online government database. Perhaps you will receive a dataset from a commercial entity. Is it clear what the source of the information/biospecimens is? Is that source available to the public or available upon request? Furthermore, is access to the information/biospecimen limited or restricted and if so, how will the information/biospecimen be obtained? Understanding the source of the information/biospecimen and an investigator’s access to that source is critical to determine whether a proposal meets the criteria for exemption.
The divide between what information/biospecimens were originally collected and why (i.e., the primary collection) and what will be used now for the secondary/retrospective review (i.e., the secondary use) is often muddy. This leaves IRB personnel unsure in determining if the protocol under review is truly ‘secondary’. It is crucial to be clear about where information/biospecimens are coming from and why they were originally collected.
Protocols submitted to the IRB often misuse, or use interchangeably, the terms de-identified and coded. Though these terms are similar they do not have the same meaning. Therefore, incorrectly using these terms leaves the IRB unsure of whether the information/biospecimens are truly de-identified or coded, which impacts their ability to make required IRB determinations.
For more information, reference the Identifiability of Research Data page.
If the research is undergoing review by the local IRB, the Research Subjects Review Board (RSRB), a data collection sheet identifying the specific data points that will be collected as part of the retrospective review is required to be submitted with the study protocol. Frequently, the RSRB finds that the information described in the study protocol does not match the data points identified in the collection sheet, which then requires clarification. The protocol, for example may state the data is de-identified, but the data collection sheet includes identifiers. Protocols will also often list all data collection points, in addition to the data collection sheet, but the two documents are inconsistent. To avoid this, it’s best practice to indicate generally the type of data being collected in the study protocol, leaving specific data collection points to be listed on the data collection sheet.
Use of protected health information regulated under HIPAA for the purposes of research still needs to comply with HIPAA requirements (category C listed above). For retrospective reviews, this typically involves requesting a waiver of HIPAA authorization, and while the waiver is often requested, the justification for the wavier is either not provided or inadequate, thereby making the waiver request unacceptable for IRB approval.
As a final best practice, to ensure all of the necessary points described above are addressed when submitting to the Research Subject’s Review Board (the University’s IRB), study teams are strongly encouraged to utilize the specimen and record review protocol template .
When a proposal involving only the use of secondary information/biospecimen does not fit into an exemption category, the research is typically reviewed via an expedited pathway. This means the IRB coordinator and board chair will conduct the review on behalf of the full board, and the protocol may need to be revised to include a waiver of consent (if not already included). During the review, the IRB board chair will confirm that the research meets the criteria for IRB approval and determine whether continuing review of the research is required.
Rather than worry about the IRB review level, it is more important for study teams to ensure all study activities are accurately described in the study protocol and the information/biospecimens needed to meet the research aims are collected. Modifying procedures or data collection points in order to fit the research into an exemption category may cause more problems in the long-run, if the data collected for analysis is compromised.