Case Reports and Case Series Guidance
Version Date: January 23, 2007
Guidance for investigators regarding case reports and case studies
The Health Sciences IRB Office frequently receives queries regarding whether publishing a case report constitutes human subjects research and therefore requires IRB review. Case reports generally involve the description of medical treatment in a patient or a few patients with a unique treatment, disease course, or outcome based on a retrospective review of medical records or they can involve a description of a unique diagnostic finding or uncommon presentation. No predetermined hypothesis or research question guides case reports and publication of the information about the patients’ medical care is not planned prior to or during the patients’ treatment. In addition, case reports are usually prepared by clinicians who have personally provided care to those patients.
The question regarding when case reports constitute research is a difficult one to address. Several major research institutions have concluded that a case report involving the description of the medical cases of three or fewer patients does not constitute human subjects research and is therefore exempt from IRB review. The University of Wisconsin-Madison Health Sciences IRB and Health Sciences Minimal Risk IRB have agreed to adopt this approach. Consequently, case reports involving three (3) or fewer patients generally do not require review by a UW-Madison IRB because they are not viewed as meeting the definition of research under the Common Rule or HIPAA Privacy Rule, which define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Case reports involving more than three patients are more likely to meet the criteria for research and require IRB review. Anyone who is unsure whether a project requires IRB review should contact the Health Sciences IRB Office for assistance.
Although a single case report involving up to three (3) patients may not require IRB review, those conducting such activities should be aware that certain HIPAA Privacy Rule provisions may apply and ethical concerns can arise if identifiable information is published. The use of protected health information to prepare a case report does not require IRB review for HIPAA Privacy Rule purposes. However, anyone who wishes to publish information that includes HIPAA identifiers or may identify the patient because of a description of a unique disease, condition, or outcome will need to obtain from the patient a signed HIPAA authorization using the Authorization for Disclosure of Medical Information for Publication or Conference Presentation form. This authorization does not need to be submitted to the IRB for review, but consultation with the UW-Madison HIPAA Privacy Officer is recommended. Additionally, those publishing case reports are strongly encouraged to obtain consent from any patients about whom information will be published. In the case of deceased individuals, consent might be obtained from the next of kin.
Many journals now require a letter or other acknowledgement from an IRB prior to publication of a single case report or a case series. Anyone asked by a journal to provide documentation of IRB approval prior to publication of a submitted case report or case series should contact the Health Sciences IRB Office, which will provide a letter confirming IRB review was not required per this guidance.
Case reports involving more than three patients are more likely to meet the criteria for research and require IRB Review. In addition, testing of a patient's biospecimen (e.g., special stain, immunohistochemistry, molecular studies) is not typically permissible as part of a case report. Anyone who is unsure whether a project requires IRB review should contact the Health Sciences IRB Office for Assistance.