HRPP Manual Section 12-8

Guidance on Exempt Category 4

This document provides guidance on Exempt Category 4 under which certain retrospective research can be determined exempt if identifiable private information is not needed for the research data that will be analyzed.

Please note that the requirements in HRPP Manual 8-1, Exemptions, apply and that the investigator must submit an exempt application to the IRB for the exempt determination. See HRPP Manual 8-1, Exemptions for requirements.

45 CFR §46.101(b) (4) exempts:

Research involving the 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.”

“Existing” means that the data…exist at the time the IRB application is submitted to the MSU HRPP office.

In order to meet the criterion for non-identifiable, you cannot record the research data you will analyze in such manner that subjects can be identified.  This means you must not record direct identifiers such as name, but also cannot record indirect identifiers such as any code that can be linked by the research to the subject (e.g., a medical record number) or any combination of variables that would allow a subject to be readily identifiable. For example, once you obtain the data, there cannot be a code or identifier that would permit you to link the abstracted data to the particular individual’s medical record to extract additional data, to check abstracted data, etc.

As an example of how to design a study of medical records to qualify for this exemption:

  1. A list of medical record numbers (MRN) can be requested with a certain diagnostic code for a given past time period.
  2. That list of MRNs is then used to retrieve the medical record.
  3. The research information from the medical record is then recorded without identifiers in the research form/database.
  4. Delete the MRN.

If there is some reason that maintaining the MRN linked to the research data is essential to the research, this would disqualify this exemption.  

Even if the project meets the criteria for Exempt Category 4, Health Insurance Portability and Accountability Act (HIPAA) requirements apply if protected health information is involved. See HRPP Manual 7-6, Health Insurance Portability and Accountability Act Compliance in Human Research for more information.

This guidance document supersedes those previously drafted.

Version Date: 7-5-2017

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