MSU HRPP Manual Section 4-3-A

4-3-A, Clinical Case Reports

This policy pertains to case reports in the field of medicine and related clinical fields.  Outside of medicine the “case report” may have different meanings and this policy does not pertain to those situations.

Case reports are medical information collected and presented on a single patient.  Case reports are done to highlight a unique treatment, a unique case, or a unique outcome.  They present clinical information on a single patient describing the treatment or outcome. Case reports are generally done by retrospective review of the medical record. Nothing is done to the patient for research purpose. Statistics are not used and the case report generally only describes existing clinical data or procedures.

While a case report does involve a human subject and may contribute to generalizable knowledge, a case report is not typically a systematic investigation and therefore does not meet the definition of research. Institutional Review Board (IRB) review is typically not required for a clinical case report on a single patient with no prior research intent.  If more than one patient will be included in a case series, it may be considered research and require IRB review. If anything will be done in the course of care with a research intent, the case report may also become research. When a program or investigator plans to call a case report research or will use it to fulfill a research requirement, it may require IRB approval. In such instances, the policies and procedures in the Human Research Protection Program (HRPP) Manual 4-3 “Determination of Human Subject Research” will be followed to determine whether the activity is human subject research.

In most cases, the investigator must obtain Health Insurance Portability and Accountability Act (HIPAA) authorization to use the patient’s health information. In rare cases, the investigator may apply for a waiver of authorization, but it is generally determined authorization can be obtained. There are instances when human subjects are not involved in research but when HIPAA may apply.

See the following HRPP Manual sections for procedures related to HIPAA:

7-6         Health Insurance Portability and Accountability Act Compliance in Human Research
7-6-A      Individual Authorization
7-6-B      Alteration or Waiver of Individual Authorization
7-6-C      Review Preparatory to Research
7-6-D      De-Identification

 

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-21-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-2-2015.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 4-3-A, Clinical Case Reports.