Case Studies/Series

Case studies typically involve the collection and presentation of detailed information about a particular participant 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 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:

Common Elements
Case Study Research
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
Specific to subjects' conditions or treatments Not as specific to individuals, instead focused more on conditions or treatments
Reported/Published specifically notes case reports Reported/Published in a way that suggests broad findings or recommendations
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.