20.2(b) Approval Categories for Retrospective Chart Reviews
No matter the review category, waivers of informed consent and HIPAA regulations may be requested. Such requests must be appropriately justified in writing.
1) EXEMPT REVIEW:
A retrospective chart review may receive IRB approval under the exempt process if the research fits both of the exempt criteria of 45 CFR 46.101(b)(4). These exempt criteria are:
a. The research involves the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens; AND
b. The data sources are publicly available or the data is recorded by the investigator in an anonymous manner such that subjects cannot be identified directly or through identifiers linked to the subject
2) EXPEDITED REVIEW:
Retrospective chart reviews may qualify for expedited review according to 45 CFR 46.110 category 5 if:
a. The research involves no more than minimal risk or minor changes in approved research; AND
b. The research involves materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as for medical treatment or diagnosis).
The expedited review procedure may not be used for studies in which identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
Unlike exempt review, expedited review of retrospective charts does not require that the data be de-identified or anonymous. Expedited reviews can be given to studies in which the data already exists, but data may be prospectively collected. No matter whether the data exists or will be prospectively collected, the HIPAA "minimum necessary" rule applies.
3) FULL BOARD REVIEW:
Retrospective medical cart review studies that do not meet the criteria outlined in categories 1 and 2 must be approved by a convened meeting of the full IRB panel. Examples of such studies might be those in which the information contained in the medical records is of a sufficiently sensitive nature that additional safeguards are necessary to protect subjects' rights. In this case, the full IRB panel will make a determination of risk and the need for informed consent.