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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

20.1 Medical Case Reports

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

February 22, 2007

20.1 Medical Case Reports

A common question is whether a "medical case report" is considered human subject research and thereby requires prospective IRB review.  For this purpose, a medical case report must fit all of the following criteria:

1)  It is a description of medical observations or an interesting medical condition, innovative treatment, presentation, disease progression or outcome

2)  It relates to three or fewer patients

3)  The patients must be those treated by the clinician preparing the report

4)  The report describes observations and is not presented as a systematic investigation designed to contribute to generalizable knowledge

5)  The report usually contains no data analysis or testing of a hypothesis

Medical case reports that fit the above criteria do not meet the federal definition of human subject research since the information in the case report is not considered generalizable knowledge.  Therefore, clinicians at the University are not required to obtain IRB approval for case reports of 1-3 patients.  The review of medical records for publication in such case reports, however, is subject to HIPAA rules and may require authorization from the patient to use the protected health information. 

When it is expected that observations will be made from a larger series of patients (more than three), it is usual that data will be systematically collected to answer a specific research question.  Such activity is considered research and the proposed study must be submitted to the IRB for review and approval prior to its commencement. 

Investigators are cautioned to distinguish between the use of innovative treatments in their clinical practice and treating patients with intent to acquire data in a systematic manner for research purposes and to contribute to generalizable knowledge.

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