Single Patient Case Reports – Dissemination of Clinical Study Data by Investigators for Education and Research Purposes

Investigators may present data from an individual patient from their clinical practice as a case study analysis/report in the format of a presentation or a journal article. The investigator must protect the participant’s privacy and confidentiality by taking appropriate measures during dissemination. The case study analysis/report does not meet the regulatory definition of research (45 CFR 46.102 (e)(7)(l)) because an individual participant case study does not contribute to generalizable knowledge. Given this, it does not require IRB review. However, if required, WCG IRB can also review the case study analysis/report and provide an official letter that it is “Not Research” to satisfy any applicable requirements of the entity to which the analysis/report will be presented.