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. What is the review level for studies involving chart review?
When information from the charts are to be recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects, the study may qualify for an exemption.
Typically, all of the materials would need to exist at the time the research is proposed in order to be eligible for this exemption. However, the study may qualify for an exemption even if an investigator records a list of identifiable information (e.g., medical record numbers) for the purposes of linking this list with other records, provided that: (a) the investigator does not include any private information such as medical information on this list of identifiers; and b) does not record identifiers once the data for the study have been obtained and the analyses begin. This flexibility cannot be applied if the study involves any component of the Veterans Administration, as they have issued guidance that this interpretation is unacceptable.
If the study is not federally funded or otherwise supported and meets the other criteria for the FLEX initiatives, it may be able to fit into a new exempt category FLEX B.
FLEX B: Research meeting all flex criteria and involving the collection or study of existing or prospectively accumulating data, documents, records, or biological specimens that exist or will exist for research or non-research purposes. Such data may be individually identifiable, so long as a breach of confidentiality would not pose more than a minimal risk to the research subjects.Examples include:
DMV records (if not already publicly available)
Fishing or boating licenses (if not already publicly available)
Marriage, divorce, and real estate transactions
Datasets from previously approved minimal risk research
Excluded from this category are individually identifiable medical, mental health, school, and employment records, as a breach of confidentiality involving this information is not considered to be minimal risk and therefore does not meet the flex criteria. If the data is pre-existing and will be abstracted or recorded in such a manner that subjects cannot be identified, directly or indirectly, through variables linked to the subjects, an exemption under category 4 may be more appropriate.
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. Do I have to obtain consent from research subjects?
Informed consent from subjects is required for research participation. However, an IRB may waive the requirement for informed consent, or the documentation of that consent, if certain criteria are met.
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 following criteria must be met:
Waiver of Documentation of Consent: 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 following criteria are met:
Written Consent: In certain instances the IRB may determine that prior written consent is required from each subject. This is more often the case for prospective chart review studies, but can be required for retrospective chart review as well. For example, an investigator wants to conduct a study that would include the review of the charts associated with all of her current or recent students, employees, or patients. The IRB may determine that the investigator should obtain prior written consent from each patient.*
5. How many subjects should I include for my total enrollment number?
A total enrollment number is not required for chart review studies.
*Guidance adapted, in part, from the Chart Review Protocol Instructions from Northwestern University Office for Research (2009).
Guidance Version date: April 1, 2016
Revised: May 24, 2016