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:
|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|