CASE STUDIES / CASE REPORTS/ CASE SERIES
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 LSUHSC 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.
Patient authorization is not usually required for case studies since they use de-identified patient health information. Some medical journals are now requiring some type of authorization by the patient. This Case Report Consent Form Template may be used when the journal requires the author to obtain the patient's permission for use of the information for the case study. The authorization may be obtained by having the patient sign this document, or verbally, depending on the requirements of the publisher.
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 (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 |
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