1. What is the difference between a retrospective and prospective chart review?
A Retrospective Chart Review evaluates patient data that is existing at the time the project is submitted to the IRB for initial review.
A Prospective Chart Review evaluates patient data that does not yet exist at the time the project is submitted to the IRB for initial review.
2. Who may conduct chart reviews?
Only individuals with existing legal access to the charts may conduct reviews. Depending on the circumstances, written permission from the institution holding the records, and/or external IRB approval, may be necessary.
3. Should I request exempt, expedited or full board review?
Exempt: Exempt review should only be requested if the information to be collected already exists and is publicly available or data will be recorded in such a manner that subjects cannot be identified, either directly or indirectly (Exempt Category #4). As data must exist at the time the project is submitted to the IRB, this limits exempt review to retrospective chart reviews. In the majority of cases, chart reviews do not qualify for exempt status because most investigators need to retain identifiers at least through the data collection process. Even if an investigator plans to eventually discard all identifiers once data collection is complete, this is not sufficient for the project to qualify for exempt review.
Expedited: Expedited review can be granted for retrospective and prospective chart reviews under expedited category #5 which is defined as: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Most chart reviews fall into this category.
Full Board: While rare, full board review may be required for both retrospective and prospective chart reviews. Some circumstances under which this occurs is if the investigator plans to collect sensitive data, or if the chart review results in a change in care for the patients whose data is being collected.
4. What type of consent should I apply for?
Waiver of Consent: Waiver of consent is the most frequently requested type of consent for both retrospective and prospective chart reviews. In order for the IRB to approve a waiver of consent, the IRB must be satisfied that the following criteria are met:
• The research involves no more than minimal risk to the subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• The research could not practicably be carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Waiver of Documentation of Consent: This type of consent is not usually requested for a chart review. Under a waiver of documentation of consent, an investigator must still obtain consent from the subject. However, the investigator does not need to obtain a signed consent form from subjects if the IRB agrees that the following criteria are met:
• That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
Written Consent: In certain instances the IRB may determine that written consent is required if the investigator is unable to justify why it’s impracticable to conduct the research without a waiver. This is more often the case for prospective chart review studies, but sometimes occurs in retrospective chart review studies. For example, an investigator wants to conduct a study that would include the review of the charts of all of her clinic patients who have a history of mental illness. The IRB may determine that the investigator should obtain prior written consent from each patient.i
i Guidance adapted, in part, from the Chart Review Protocol Instructions from Northwestern University Office for Research (2009).
Guidance Version date: February 1, 2011