Is IRB review required for publication of a case study?

August 16, 2019 Yvonne Higgins

Question:

Is IRB review required for publication of a single-patient case study, from a case that occurred several years ago?
- Physician, private practice with a university faculty appointment

Response: 

Research is defined by the federal regulations as systematic investigation designed to contribute to generalizable knowledge.  The retrospective analysis of the experience of single patient’s experience with standard treatments, would not likely meet an IRB’s definition of research and would not require review or exemption by the IRB. 

Many IRB policies state that the analysis of a case series (more than 3 cases) meets the definition of human research and requires the submission and review by the IRB.

Note that some journals may require acknowledgement from the IRB that review of a case study is not required. You may want to check with the specific journal on their requirements.  If you are trying to publish in a journal that is asking for evidence of IRB review, it can be difficult when IRB review was not prospectively obtained, even if the reason that it was not obtained is that it was not actually required. 

Some IRBs will look at the project and provide letters that state that had the project been submitted to them prospectively, they would have found that it did not require IRB review, and that documentation is satisfactory to the journal.  However, we have heard of situations where journals refused to accept this kind of retrospective letter.

Also note that the HIPAA Privacy Rule requirements apply to the use and disclosure of protected health information PHI.

 

About the Author

Yvonne Higgins

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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