Case Reports and Case Series
A case report is a detailed report of the diagnosis, treatment, response to treatment, and follow-up after treatment of an individual patient. A case series is group of case reports involving patients who were given similar treatment. Case reports and case series usually contain demographic information about the patient(s), for example, age, gender, ethnic origin.
When information on more than three patients is included, the case series is considered to be a systematic investigation designed to contribute to generalizable knowledge (i.e., research), and therefore submission is required to the IRB.
For all case reports and case series, a signed HIPAA authorization should be obtained from the patients or their legally authorized representatives for the use and disclosure of their Protected Health Information. The only exception to the requirement for obtaining authorization is if the author of a case report or case series believes that the information is not identifiable; in this case, the author must consult with the Privacy Officer at Boston Medical Center (DGemail@example.com) or the HIPAA Privacy Officer of Boston University (firstname.lastname@example.org) to seek an expert opinion about the magnitude of the risk of identifying an individual.
For case reports or case series containing more than three patients, the HIPAA authorization should be part of the consent form that is reviewed by the IRB.
For case reports or case series containing three or fewer patients, authors should prepare an authorization form using the following templates and arrange for review as indicated below. The red text in the template should be customized for the specific case report or case series. Please note that for deceased patients, authorization must be obtained from the personal representative, who is the administrator or executor of the patient’s estate.
- Boston Medical Center (BMC Case Report HIPAA Authorization Template) – review by the Privacy Officer at Boston Medical Center (DGemail@example.com); a copy of the authorization must be filed in each patient’s medical record.
- Goldman School of Dental Medicine (GSDM Case Report HIPAA Authorization Template) – review by the HIPAA Privacy Officer of Boston University (firstname.lastname@example.org)