Does research involving retrospective review of patient charts require IRB review? What if some of the subjects are children? Do the researchers need training?
Research that involves review of medical records may qualify for exemption if the information is recorded by the investigator in a way that “the identity of the human subjects cannot be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.”1 Research with children is eligible for exemption under this category.
In order to qualify for this category, a researcher may access medical chart information such a patient name or medical record number; but the researcher may not record or link these identifiers to the research data set.
If the researcher does intend to retain any links to identifiers, then the research will require review by the IRB and may be eligible for expedited review.
Here is a link to information about the WCG IRB submission process. The IRB application will prompt you for the information needed by the IRB to make an exemption determination or to perform a review of the research. You may also contact IRB Client Services with protocol specific questions at email@example.com.
- 45 CFR 46 Category 4: Common Rule, Secondary research for which consent is not required