FAQs-Children's Hospital and Research Center of Oakland Institutional Review Board
"Do I need IRB approval for a case report?
Data concerning one individual, their family, and/or environment, including medical history and any other information, collected for the purposes of analyzing and diagnosing the individual’s condition or for instructional purposes, is considered a “case study.” Although this case reporting does involve the intent to publish results, it does not involve a testable hypothesis. Consequently, the wish to publish a single case report is not considered to be research and the IRB does not require the submission of a protocol to publish the case report.
If more than one case occurs of the specific condition or medical anomaly, or the investigators begin to formulate a hypothesis or attempt to gather further information on cases of this type with the intent to publish the results, activities cross into what would be considered “research” and it becomes necessary to submit a research proposal to the IRB.
Although publishing a single case report may not require submission to the IRB, investigators should be aware of the use of individually identifiable health information in their publications. Under HIPAA, the disclosure of an individual’s protected health information must be authorized by that individual. In other words, if a case report contains any identifiers as defined by the HIPAA regulations, authorization to disclose this information in a publication must be sought from the individual whose information is being disclosed. The subject must sign a consent form (or authorization) to disclose this information. This authorization/consent must be reviewed by the IRB, which serves as the Privacy Board for Children's Hospital & Research Center Oakland. Many journals now require authorization/consent from the subject of the article before publication.
Case reports often involve reporting on a rare disorder, condition, or course of treatment. In such cases, individuals may be more easily identified as being the subject of a publication than individuals with a more common disease or condition. Consequently, this rare disorder may fall under the category of “any other unique identifying characteristic” under the HIPAA regulations, and thus be considered Protected Health Information. Researchers must then obtain a subject’s authorization before publishing a report, even when no other identifiers are being disclosed, because the subject may be able to be identified by their disorder. This authorization again must be reviewed by the IRB before use."