Consent for case report

[TheBoneDoctah]

My doctor said that I could write up a case report on a patient yesterday. I wanted to present it at a conference and possibly write up a paper to submit to a journal. As far as patient consent, do I need just a verbal consent from the patient or do I need something signed? I’ve been searching around and don’t even really know what department in the hospital to go to ask this question.

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[Dr G Oogle]

My doctor said that I could write up a case report on a patient yesterday. I wanted to present it at a conference and possibly write up a paper to submit to a journal. As far as patient consent, do I need just a verbal consent from the patient or do I need something signed? I’ve been searching around and don’t even really know what department in the hospital to go to ask this question.

Every hospital IRB is different, but in general you will need a patient’s written consent to publish a case report, and will need to apply for an IRB exemption. Contact the hospital’s IRB department to get an specific answer. You can probably just type “ ‘hospital where you’re at’ IRB contact” into google and get an email, phone and office location. They will also have templates for you to use.

 

[Merely]

What if it’s a private practice with no IRB?

 

[Dr G Oogle]

What if it’s a private practice with no IRB?

Is the practice affiliated with a hospital? Or completely stand alone? What is the nature of the case? Was it inpatient at any point during the workup? If the practice/hospital does not have an IRB than touch base with your Med school. In general if all human subjects research (including case reports) must be overseen by an IRB. Look at page 1364 of the attached for options on what to do if there is no affiliated IRB. Also keep in mind that it is a short walk before the effort to publish a case report become greater than the reward. http://www.rcjournal.com/contents/10.08/10.08.1362.pdf

 

[TheBoneDoctah]

Every hospital IRB is different, but in general you will need a patient’s written consent to publish a case report, and will need to apply for an IRB exemption. Contact the hospital’s IRB department to get an specific answer. You can probably just type “ ‘hospital where you’re at’ IRB contact” into google and get an email, phone and office location. They will also have templates for you to use.

On the hospital IRB website it states it costs like $2,200 to submit to IRB. You're saying that every medical student who writes case reports goes through IRB approval and pays this kind of money?

 

[Dr G Oogle]

What if it’s a private practice with no IRB?

Is the practice affiliated with a hospital? Or completely stand alone? What is the nature of the case? Was it inpatient at any point during the workup?

On the hospital IRB website it states it costs like $2,200 to submit to IRB. You're saying that every medical student who writes case reports goes through IRB approval and pays this kind of money?

What?! No, IRB submissions are generally free unless this hospital doesn’t have their own and is using a commercial IRB or is partnering with another institution and have to pay some kind of fee and is then charging people to use this outside hospital IRB. I have published close to 30 papers in 4 different institutions (all academic) and have never had to pay, nor have I ever heard of any of my colleagues having to pay. Like I said touch base with your school, but if you cannot find a way to get some kind of IRB approval for this case report it’s basically a no go. There may be some process for getting patient consent for a case report outside of an IRB that I am not aware of though

 

[TheBoneDoctah]

Is the practice affiliated with a hospital? Or completely stand alone? What is the nature of the case? Was it inpatient at any point during the workup?


What?! No, IRB submissions are generally free unless this hospital doesn’t have their own and is using a commercial IRB or is partnering with another institution and have to pay some kind of fee and is then charging people to use this outside hospital IRB. I have published close to 30 papers in 4 different institutions (all academic) and have never had to pay, nor have I ever heard of any of my colleagues having to pay. Like I said touch base with your school, but if you cannot find a way to get some kind of IRB approval for this case report it’s basically a no go. There may be some process for getting patient consent for a case report outside of an IRB that I am not aware of though

Sorry, this may be a stupid question, but is this journal specific? Can you not just get verbal consent from the patient especially if you are removing all identifiers?

Is IRB approval needed for a poster presentation at a conference?

 

[operaman]

At my current and last institution a case report was not considered research and did not require formal IRB approval. I would submit them and they would issue a letter saying it was exempt.

 

[Dr G Oogle]

At my current and last institution a case report was not considered research and did not require formal IRB approval. I would submit them and they would issue a letter saying it was exempt.

It may be journal specific. You have to check with journal, just figure out which journal you want to submit and go on their website. @operman is correct in that you will likely get an exemption, but you generally have to submit for an exemption. And the very few case reports I’ve done, we’ve needed written consent from the patient, but maybe journal/institution specific.

 

[TheBoneDoctah]

It may be journal specific. You have to check with journal, just figure out which journal you want to submit and go on their website. @operman is correct in that you will likely get an exemption, but you generally have to submit for an exemption. And the very few case reports I’ve done, we’ve needed written consent from the patient, but maybe journal/institution specific.

For the written consent from the patient, is this on IRB paperwork or journal paperwork?

 

[operaman]

It may be journal specific. You have to check with journal, just figure out which journal you want to submit and go on their website. @operman is correct in that you will likely get an exemption, but you generally have to submit for an exemption. And the very few case reports I’ve done, we’ve needed written consent from the patient, but maybe journal/institution specific.

I believe our patients sign a blanket consent that covers things like case reports or QI stuff whenever they come seek care at our hospital. Our IRB counts anything with 3 patients or fewer as not being research and not requiring a separate informed consent process.

 

[TheBoneDoctah]

I believe our patients sign a blanket consent that covers things like case reports or QI stuff whenever they come seek care at our hospital. Our IRB counts anything with 3 patients or fewer as not being research and not requiring a separate informed consent process.

Thank you so much for the help.

One more question: I think the patient should be getting discharged next week and tomorrow is my last day on service. I want to make sure I get the written consent before he is discharged. Any advice since tomorrow is Sunday and I am guessing IRB office is closed?

 

[operaman]

Thank you so much for the help.

One more question: I think the patient should be getting discharged next week and tomorrow is my last day on service. I want to make sure I get the written consent before he is discharged. Any advice since tomorrow is Sunday and I am guessing IRB office is closed?

Your IRB should have a website that would lay out their policies. They should have something there about case reports since this is such a common thing.

 

[TheBoneDoctah]

Off Tufts website:

For De-identified Case Reports
If case reports are not identifiable, there is no need to obtain the patient’s signed authorization, to contact the HIPAA Privacy Officer, or to submit any documents to the IRB.

I know this isn't my hospital and I will still check with IRB ASAP.

 

[Dwan]

Sorry, this may be a stupid question, but is this journal specific? Can you not just get verbal consent from the patient especially if you are removing all identifiers?

Is IRB approval needed for a poster presentation at a conference?

Yeah, it's journal specific. For example, if you plan to submit to BMJ case reports, you will need to fill a consent form.
http://casereports.bmj.com/site/about/guidelines.xhtml#patientconsent

 

[TheBoneDoctah]

Yeah, it's journal specific. For example, if you plan to submit to BMJ case reports, you will need to fill a consent form.
http://casereports.bmj.com/site/about/guidelines.xhtml#patientconsent

Even on BMJ it says “identifiable” though.

 

[Med Ed]

My doctor said that I could write up a case report on a patient yesterday. I wanted to present it at a conference and possibly write up a paper to submit to a journal. As far as patient consent, do I need just a verbal consent from the patient or do I need something signed? I’ve been searching around and don’t even really know what department in the hospital to go to ask this question.

If there is nothing identifiable in the case report, and you are using information that was collected in the course of clinical care, there is no need to perform any type of consent. Case reports are merely observational and not generalizable, and therefore does not meet the DHHS definition of research. Again, as long as there is nothing identifiable in the report (e.g. patient photo with visible, distinctive tattoo) then there is not need to even contact the IRB.

 

[Naruhodo]

Written consent is always a good idea. As others have pointed out it is required by some journals (though it's a pet peeve of mine when they require you use their special consent instead of your institutional consent). Ditto to Operamen at my institution a single case report is not considered research and does not require IRB approval, but if you describe more than 3 patients then you have to go to the IRB. Totally arbitrary IMHO, and also why you'll see a ton of reports describing "3 patients with condition X".
De-identified is tricky. If a condition is rare enough it may be nearly impossible. Think about how the patient/ family will feel reading your report (ideally share it with them before you even submit), and try to always do the humane thing. Conference presentations tend to be more relaxed and rarely require proof of consent, but please discuss it with the patient at the very least.

 

[Dwan]

Even on BMJ it says “identifiable” though.

Pretty much everything counts as identifiable except images:
"For "Images in ..." articles where there is no personal information and very limited clinical data we may be able to waive consent. Consent will not be waived for case reports involving living patients."

All cases I've heard of from my institution that were published here had required consent.

 

[OrthoTraumaMD]

The hospital irb has an “expedited approval” form that is meant for research using deidentified data. You do not need a written consent.


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[franklyMed]

Pretty much everything counts as identifiable except images:
"For "Images in ..." articles where there is no personal information and very limited clinical data we may be able to waive consent. Consent will not be waived for case reports involving living patients."

All cases I've heard of from my institution that were published here had required consent.

If I'm publishing something that falls under this exception where do I find "waiver" for BMJ; is it simply a letter saying that we are waiving consent or is there a specific form?

 

[operaman]

If I'm publishing something that falls under this exception where do I find "waiver" for BMJ; is it simply a letter saying that we are waiving consent or is there a specific form?

Usually this means a letter from your IRB.

I would encourage anyone with questions like this to simply pick up the phone and call your IRB. They usually have some office staff who handle the exempt and expedited stuff anyhow and they can help steer you through the process. Sometimes the wording on the web forms can be confusing and having a human to talk to makes it much easier.

 

[RJ McReady]

I was a co author on a case report done by a physician in private practice-
There was no IRB approval required, only written consent from the patient to allow de-identified data to be published in print and/or electronic format.