Ethical clearance/consent needed for case reports?

[lucid_interval]

Is consent from the patient or ethical clearance needed for publication of case reports if no identificable information is mentioned?

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[gamerEMdoc]

No, but they still have to typically go through IRB

 

[gro2001]

No, but they still have to typically go through IRB

Actually case reports do not meet the definition of human subject research (they are scholarly activity but are specifically not research because they do not contribute to generalizable knowledge). Most institutions do not require you to go through IRB approval. Journals typically require you to answer a question about whether IRB approval was sought. If you answer no, they will ask why. An explanation stating that this paper does not meet the definition of research as it is a single case report should suffice. If it does not, your institution's IRB administration can issue a letter stating the same thing (which should not require a board review, only admin).

This is not even an exemption (which should be determined by an IRB not an investigator), this is just not human subject research and therefore falls entirely outside the scope of an IRB, like geology research or a newspaper interview.

The situation is a little different with case series. At a certain point you start getting enough data points for someone to say this is generalizable knowledge. There is no hard line but typically institutions pick some arbitrary small number, like 3-5 cases, as a cutoff above which an IRB review is required.

http://www.cumc.columbia.edu/harlem-hospital/sites/default/files/Consentforcasereport.pdf

Case Report Publication Guidance: IRB Review and HIPAA Compliance

www.hopkinsmedicine.org

Case Studies/Series

 

[deleted109597]

If there is something unique enough to be a case report, then it's unique enough to be PHI. You generally still want the patient or surviving family consent on these.

 

[gamerEMdoc]

Actually case reports do not meet the definition of human subject research (they are scholarly activity but are specifically not research because they do not contribute to generalizable knowledge). Most institutions do not require you to go through IRB approval. Journals typically require you to answer a question about whether IRB approval was sought. If you answer no, they will ask why. An explanation stating that this paper does not meet the definition of research as it is a single case report should suffice. If it does not, your institution's IRB administration can issue a letter stating the same thing (which should not require a board review, only admin).

This is not even an exemption (which should be determined by an IRB not an investigator), this is just not human subject research and therefore falls entirely outside the scope of an IRB, like geology research or a newspaper interview.

The situation is a little different with case series. At a certain point you start getting enough data points for someone to say this is generalizable knowledge. There is no hard line but typically institutions pick some arbitrary small number, like 3-5 cases, as a cutoff above which an IRB review is required.

http://www.cumc.columbia.edu/harlem-hospital/sites/default/files/Consentforcasereport.pdf

Case Report Publication Guidance: IRB Review and HIPAA Compliance

www.hopkinsmedicine.org

Case Studies/Series

Yeah, at my hospital they still want all case reports to go through the IRB. I have zero idea why.

 

[gro2001]

Yeah, at my hospital they still want all case reports to go through the IRB. I have zero idea why.

That's pretty crazy. Might be worth it to send an email to the IRB committee chair or head of research administration with some of those links and ask for clarification as to why they want it that way since most authorities agree that case reports are not human subject research.