A common question is whether a "medical case report" is considered human subject research and thereby requires prospective IRB review. For this purpose, a medical case report must fit all of the following criteria:
1) It is a description of medical observations or an interesting medical condition, innovative treatment, presentation, disease progression or outcome
2) It relates to three or fewer patients
3) The patients must be those treated by the clinician preparing the report
4) The report describes observations and is not presented as a systematic investigation designed to contribute to generalizable knowledge
5) The report usually contains no data analysis or testing of a hypothesis
Medical case reports that fit the above criteria do not meet the federal definition of human subject research since the information in the case report is not considered generalizable knowledge. Therefore, clinicians at the University are not required to obtain IRB approval for case reports of 1-3 patients. The review of medical records for publication in such case reports, however, is subject to HIPAA rules and may require authorization from the patient to use the protected health information.
When it is expected that observations will be made from a larger series of patients (more than three), it is usual that data will be systematically collected to answer a specific research question. Such activity is considered research and the proposed study must be submitted to the IRB for review and approval prior to its commencement.
Investigators are cautioned to distinguish between the use of innovative treatments in their clinical practice and treating patients with intent to acquire data in a systematic manner for research purposes and to contribute to generalizable knowledge.