Research based on review of patient records is subject to IRB review regardless of where the records are located (e.g. Health Information Services, departmental database, shadow records in your department). The method for and the type of data to be collected will dictate the category of IRB review that is appropriate.
Note: All chart review proposals must be submitted to the IRB prior to initiation. A final determination as to whether the proposal qualifies for exempt or expedited review can only be made by the IRB chairman to whom your protocol is assigned.
Review of existing patient records may be considered exempt if the records are collected without identifiers or a link to identifiers. The records and data must be in existence before the review is begun, and there must be no possible way to go back to the records or re-link the data at a later date. Additionally, the record review must be conducted by an individual (investigator) who would normally have access to the records as part of the patient’s routine clinical care.
In most cases, a retrospective chart review that does not record identifiers falls under the following exempt category:
“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 in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.”
To submit a retrospective, anonymous chart review to the IRB for consideration submit an initial application, along with a separate protocol or research plan, data collection sheet, and any other material that will be used. The protocol should explain what you propose to do, why you propose to do it/the question you hope to answer, and specifics of how it will be done in enough detail to be clear to the reviewer (usually one of the IRB chairmen).
The data collection sheet should specifically identify all of the information that will be collected from each chart (a flow sheet template is often used – this can be included in the protocol). What you intend to do with the collected data (i.e. presentation, publication, preliminary data for a grant, etc.) should also be explained.
Federal regulation regarding exempt studies - 45 CFR 46.101
Review of patient records, retrospective, prospective, or both, for which it is necessary to collect identifying information or maintain a code or link to the data source may qualify for expedited review.
Based upon the study, the details being collected and the risks to the patient (including confidentiality risks), the study might qualify for a waiver of obtaining informed consent/authorization.
To submit a proposal for this type of chart review to the IRB for consideration submit an Initial Application, along with a separate protocol or research plan, data collection sheet, and any other material that will be used. The protocol should explain what you propose to do, why you propose to do it/the question you hope to answer, and specifics of how it will be done in enough detail to be clear to the reviewer (usually one of the IRB chairmen).
Federal regulation regarding expedited studies - 45 CFR 46.110 and 21 CFR 56.110
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