Case studies typically involve the collection and presentation of detailed information about a particular patient/person or small group to highlight an interesting condition, treatment, presentation or outcome.
To determine whether a case study or case series requires IRB review, recall the definition of human subjects research; specifically,that it is designed to contribute to generalizable knowledge. A case study, in contrast, tends to highlight one or a few particular cases for purposes of demonstration rather than for purposes of drawing generalized conclusions.
Below are some criteria that tend to be representative of either case studies or research; this list is to be used as a guide not as a definitive determination. Note that Emory has used five case studies as a threshold above which we normally wish to review the project as "research." While somewhat arbitrary, we found it necessary for consistency.
While HIPAA authorization may not always be required, there may be instances in which authorization from the patient may be needed to use their health information. Emory has a Case Study HIPAA Authorization template which can be used in these instances. In addition, if you will be using a photo from the patient, you may obtain their consent using a consent form for that purpose. The School of Medicine has a document you may use in their website.
NOTE: If a trainee or student will work up the case(s) for publication, and the trainee/student does not have a clinical need to have access to the relevant record(s), they may obtain access for the case study under the "EHC Graduate and Undergraduate Medical Education PHI Policy." Please contact Darcelle Skeete in the EHC Office of Compliance before proceeding, for more information.
|Report on 5 or fewer subjects||Report on more than 5 subjects|
|Not meant to be a representative sample (not drawing conclusions)||Drawing conclusions about a broader population based on the reported cases (even if not statistically significant; e.g. pilot studies can be "research")|
|Reported/Published without attempting to draw broader conclusions||Reported/Published in a way that suggests broad findings or recommendations|