Are Chart Reviews Expedited or Exempt?

There is often confusion as to the category of chart reviews.

The Code of Federal Regulations (45CFR46.101(2)) states that a study can not be exempt if “information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and  ii) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.”

The key here is what information will be recorded. If you are going to record any identifiers (or links) and the information recorded is of a sensitive nature, then you should submit the study for Expedited review.

When submitting a chart review for Institutional Review Board (IRB) approval, a list of information that will be recorded must be included so the chair can make a determination as to whether the study can be Exempted or Expedited.

If the study will be submitted for Expedited approval, remember to include the Expedited Protocol Assessment Form as part of your submission packet.